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Showing posts with label Covid-19 vaccine. Show all posts
Showing posts with label Covid-19 vaccine. Show all posts

COVID-19 Vaccine Can Turn People Into "Crocodiles", Says Brazilian President Bolsonaro

 "In the Pfizer contract it's very clear: 'we're not responsible for any side effects.' If you turn into a crocodile, it's your problem," Jair Bolsonaro said on Thursday.

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World News/Covid-19 Vaccine Tracker: Brazilian President Jair Bolsonaro has launched an attack on coronavirus vaccines, even suggesting that the one developed by Pfizer-BioNTech could turn people into crocodiles or bearded ladies.

The far-right leader has been sceptical of the coronavirus since it first emerged late last year, branding it "a little flu." in the week he insisted he wouldn't be vaccinated, even while launching the country's mass innoculation program.

Also Read| London move to heights alert for new variant of Coronavirus found in UK

"In the Pfizer contract it's very clear: 'we're not responsible for any side effects.' If you turn into a crocodile, it is your problem," Bolsonaro said on Thursday.

That vaccine has been undergoing tests in Brazil for weeks and is already getting used within the united states and Britain.

Also Read|Uk Watchdog issued allergy warning for Pfizer Covid-19 Vaccine

"If you become superhuman, if a woman starts to grow a beard or if a man starts to speak with an effeminate voice, they will not have anything to do with it," he said, pertaining to the drug manufacturers.

When launching the immunization campaign on Wednesday, Bolsonaro also said it might be free but not compulsory.

Also Read| America Will start Vaccination of Pfizer Vaccine From Monday: Official

But the Supreme Court on Thursday ruled that the vaccine was obligatory, although couldn't be "forced" on people.

That means authorities can fine people for not being vaccinated and ban them from certain public spaces, but not force them to take it.

Brazil has recorded quite 7.1 million cases and almost 185,000 deaths from Covid-19 amongst its 212 million population.

Bolsonaro said that when a vaccine has been certified by Brazil's regulatory authority Anvisa, "it will be available for everyone that wants it. But me, I won't get vaccinated."

"Some people say I'm giving a bad example. But to the imbeciles, to the idiots that say this, I tell them I've already caught the virus, I have the antibodies, so why get vaccinated?"

There are alittle number of cases of apparent reinfection although there's no certainty over whether an individual are often reinfected or how long immunity lasts.

Bolsonaro caught the virus in July but recovered within three weeks.

Brazil is within the middle of a second wave of coronavirus infections.

After peaking in June to August cases had been dropping but that changed in November.

On Thursday, Brazil surpassed 1,000 daily deaths from covid-19 for the first time since September.

The country's immunization program has been widely criticized for being late and chaotic, not least given Bolsonaro's opposition.

America Will start Vaccination of Pfizer Vaccine From Monday: Official

 General Gus Perna told reporters the first doses are going to be shipped Sunday which starting Monday morning, "We are operationally 100% confident that we will get the vaccines to the American people."

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World News/Covid-19 Vaccine Tracker: Americans will start receiving the Pfizer-BioNTech Covid-19 vaccine on Monday, the official in charge of the distribution operation said Saturday.

ALSO READ| Uk Watchdog issued allergy warning for Pfizer Covid-19 Vaccine

General Gus Perna told reporters the first doses are going to be shipped Sunday which starting Monday morning, "We are operationally 100% confident that we will get the vaccines to the American people."

"Expect 145 sites across all the states to receive vaccine on Monday, another 425 sites on Tuesday. and the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer-BioNTech vaccine," he said.

Also Read| British Grandma Is 1st In World To Get Pfizer Covid-19 Vaccine Outside Trial

The first push will vaccinate about three million people.

Federal health authorities have recommended that health care workers and nursing home residents be at the front of the road , but the decisions are going to be left to states.

Also Read| Pfizer wants approval for emergency use in India after UK

The US became the sixth country to green light the Pfizer vaccine on Friday night.

It has been shown to be 95 percent effective in preventing Covid-19 infection compared to a placebo.

But the FDA has advised people that have severe allergies to ingredients within the drug to avoid getting immunized for the time being.


British Grandma Is 1st In World To Get Pfizer Covid-19 Vaccine Outside Trial

 An early riser, Keenan received the jab at her local hospital in Coventry, central England, on Tuesday morning at 0631 GMT, a week before she turns 91.

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World News/Covid-19 Vaccine Tracker: Margaret Keenan, a 90-year-old grandmother from Northern Ireland , became the first person within the world on Tuesday to receive the Pfizer COVID-19 vaccine shot outside of a trial as Britain began vaccinating its population.

An early riser, Keenan received the Pfizer-BioNTech vaccine at her local hospital in Coventry, central England, on Tuesday morning at 0631 GMT, a week before she turns 91.

Also Read| Pfizer wants approval for emergency use in India after UK

A video showed Keenan being pushed in a wheelchair out of the ward while nursing staff clad in protective gear lined the corridor to applaud and cheer, in an echo of moving video clips released through the year when COVID-19 survivors finally left hospital.

Britain is the first Western country to start out immunising its general population in what has been hailed as a decisive watershed in defeating the coronavirus.

Also Read|UK approved Pfizer-BioNtech's COVID-19 vaccine, Vaccination starting from next week

"I feel so privileged to be the first person vaccinated against COVID-19," said Keenan, as she received the shot from a nurse originally from the Philippines in front of a photographer and television crew.

"It's the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year."

Keenan, referred to as Maggie to her friends, is a former jewellery shop assistant who only retired four years ago. She has a daughter, a son and 4 grandchildren.

Video footage showed her wearing a light blue mask, a gray cardigan along with a blue t-shirt with a penguin in snow and therefore the message "Merry Christmas" as she received the shot in her left arm from nurse May Parsons.

Also Read|Covid-19 Vaccine: Serum Institute will apply for emergency authorisation in next 2 weeks

"We Will Beat This Together"

Parsons, one among many thousands of individuals from round the world employed in Britain's National Health Service (NHS), where she has worked for twenty-four years, said the last few months had been tough, but there was now light at the end of the tunnel.

Britain is the worst-hit European country from COVID-19, with over 61,000 deaths. Prime Minister Boris Johnson hopes to show the tide against the disease by rolling out the Pfizer/BioNTech vaccine before the united states or European Union .

The mass inoculation will fuel hope the world may be turning a corner in the fight against an epidemic that has crushed economies and killed over 1.5 million, although ultra-cold storage and tricky logistics will limit its use for now.

"Thank you to our NHS, to all of the scientists who worked so hard to develop this vaccine, to all the volunteers - and to everyone who has been following the rules to protect others," Johnson said on Twitter.

Also Read|Russia vaccine to be made in India:100 million doses of effective Sputnik V will be made every year, production will start next year

"We will beat this together."

British Health Secretary Matt Hancock and Stephen Powis, medical director for NHS England, said they both found it very emotional watching the vaccine programme rollout.

The BBC said the second patient to receive the jab in Britain was a person named william shakespeare from Warwickshire.

Britain has ordered 40 million doses of the Pfizer/BioNTech shot. As everyone requires two doses, that's enough to vaccinate 20 million people within the country of 67 million.

About 800,000 doses are expected to be available within the first week, with care home residents and carers, the over-80s and some health service workers the highest priority to get them.

UK approved Pfizer-BioNtech's COVID-19 vaccine, Vaccination starting from next week

 A vaccine is seen as the best chance for the planet to get back to some semblance of normality amid a worldwide pandemic which has killed nearly 1.5 million people and upended the worldwide economy.

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World News/Covid-19 Vaccine Tracker: Britain approved Pfizer's COVID-19 vaccine on Wednesday, jumping before the united states and Europe to become the West's first country to formally endorse a jab it said should reach the foremost vulnerable people early next week.

Prime Minister Boris Johnson touted the medicine authority's approval as a worldwide win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the planet economy and upended normal life.

Britain's Medicines and Healthcare products regulatory agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time - just 23 days since Pfizer published the first data from its final stage clinical trial.

"It's fantastic," Johnson said. "The vaccine will begin to be made available across the uk from next week. it's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."

The world's big powers are racing for a vaccine for months in an attempt to be first to begin the long road to recovery.

The approval of a vaccine to be used almost exactly a year since the novel coronavirus emerged in Wuhan, China, may be a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

China has already given emergency approval for 3 experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.

But the european Union's drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, because it was supported more evidence and checks that the procedure chosen by Britain.

British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need - the elderly, those in care homes and health workers.

'HISTORIC MOMENT'

The U.S. drugmaker said Britain's emergency use authorization marks a historic moment within the fight against COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the uk," said CEO Bourla.

"As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world."

Britain's medicines regulator approved the vaccine in record time - partly by doing a "rolling" concurrent analysis of knowledge and therefore the manufacturing process while Pfizer raced to conclude trials.

"With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks," said Andrew Hill, senior visiting research fellow within the Department of Pharmacology at the University of Liverpool.

"However, we need new independent clinical trials to monitor long-term safety and efficacy."

The U.S. Food and Drug Administration (FDA) is about to satisfy on Dec. 10 to debate whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and therefore the European Medicines Agency said it could give emergency approval for the shot by Dec. 29.

"The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme," said Ugur Sahin, chief executive and co-founder of BioNTech.

U.S. media reported on Tuesday that the White House had summoned FDA head Stephen Hahn to discuss why the U.S. agency hadn't moved faster to authorise Pfizer's vaccine.


FIRST IN LINE?

Britain said it might start vaccinating ordinary people early next week after it gets 800,000 doses from Pfizer's manufacturing centre in Belgium. The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine.

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine - enough for slightly below a third of the population as two shots of the jab are needed per person to gain immunity.

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge as long as the vaccine must be shipped and stored at -70C (-94F), the sort of temperature typical of an Antarctic winter.

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days, from up to fifteen days previously guided. Afterwards, the vaccine are often kept at fridge temperatures for up to five days.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70% effective in pivotal trials and could be up to 90% effective.



Also Read|



Covid-19 Vaccine: Serum Institute will apply for emergency authorisation in next 2 weeks

 University of Oxford and AstraZeneca on Monday said that their Covid-19 vaccine was up to 90 per cent effective in late-stage clinical trials.

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World News/Covid-19 Vaccine Tracker : The Serum Institute of India (SII) will apply for emergency license of Covid-19 vaccine within the next fortnight , said chief executive officer Adar Poonawalla on Saturday.

Speaking to reporters through virtual press conference minutes after Prime Minister Narendra Modi’s visit to SII’s facility in Pune on Saturday, Poonawalla said, the vaccine, post-authorization, will initially be distributed in India then to African countries.

“We are in process of applying for emergency licensing in the next two weeks. we will have to wait and see when we get the authorisation,” said Poonawalla while responding to an issue on Covishield vaccine’s distribution within the country.

“The vaccine will be distributed initially in India and then we will look at COVAX countries which are mainly in Africa. The united kingdom and European markets are being taken care of by AstraZeneca and Oxford. If they need our help for scaling up production capacity, we are always there to support them.”

The SII, the world’s largest vaccine maker, has signed an agreement to manufacture the vaccine developed by the Jenner Institute of Oxford University together with British-Swedish pharma company AstraZeneca.

University of Oxford and AstraZeneca on Monday said that their Covid-19 vaccine was up to 90 per cent effective in late-stage clinical trials, raising hopes for the arrival of shots in India by the end of the year.

According to Poonawalla, the Covishiled vaccine has proved effective during trials. “What we found in Covishield during trials globally was that there was zero hospitalisation and 60 per cent reduction in sterilizing immunity.”

Poonawala said during PM Modi’s visit to the manufacturing facility at SII, various issues about pricing and logistics also as pros and cons of other vaccine candidates were discussed.

The SII is currently producing 50-60 million doses per month and plans to proportion to 100 million doses by January next year.

“We are producing 50 to 60 million doses per month and post-January, it will be scaled up to 100 million doses a month. we have built the largest pandemic-level facility in Pune and our new campus in Mandri. That was also showcased to the PM with a tour around the facility and a lot of detailed discussions,” Poonawalla further mentioned.

On signing any deal with the govt of India, Poonawalla said there has been no contract signed with centre yet.

“As of now, we don’t have anything in writing on how many doses they will purchase but as indicated by the health ministry, they would need 300-400 million doses by July 2021,” said the SII CEO.

Poonawala also claimed the Oxford drug will be transported easily at normal refrigerator temperatures, unlike a number of the other candidates which require extreme cold storage.


Also Read|

Russia vaccine to be made in India:100 million doses of effective Sputnik V will be made every year, production will start next year


Russia vaccine to be made in India:100 million doses of effective Sputnik V will be made every year, production will start next year

 

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  • India's pharmaceutical company Hetero ties up with Russian Direct Investment Fund
  • Sputnik V free in Russia, for other countries its price will be less than 700 rupees


India News/Covid-19 Vaccine Tracker: The Russian Direct Investment Fund (RDIF) and India's pharmaceutical company Hetero have tied up to produce Corona's vaccine Sputnik V. This agreement is to make 100 million doses every year in India. Production will start from next year.

Sputnik V has been created by the Gameleya National Research Center for Epidemiology and Microbiology of Russia. RDIF is overseeing its production and promotion abroad. The clinical trial for the third phase of the vaccine has been approved. These trials are ongoing in many countries including Belarus, UAE, Venezuela. According to IDIF, the second and third phase trials are going on in India.

More than 50 countries have requested to make 120 million doses of this vaccine. The vaccine will be produced in India, China, Brazil, South Korea and other countries for supply in the global market.

'Big step in the fight against Corona'

Murali Krishna Reddy, Director, International Marketing, Hetero Labs Ltd, said Sputnik V is most effective in treating Kovid-19. We are very pleased with this partnership with RDIF to develop the vaccine. This partnership is another step towards fulfilling our commitment and the Make in India campaign in the fight against Corona.
At the same time, RDIF CEO Kirill Dmitriev said that we are happy to announce the agreement with Hetero. This will pave the way for the production of safe and most effective corona vaccine in India. Thank you for partnering with Hetero. This will help us to increase the production capacity and provide a better solution to the people of India in this challenging period of Corona.

Hetero has over 25 years of experience
Hyderabad based company Hetero is India's leading generic pharmaceutical company. It was founded in 1993 by Dr. BPS Reddy. It is the world's largest manufacturer of anti-retroviral drugs for the treatment of HIV / AIDS. The company has over 25 years of experience in the pharmaceutical industry. Hetero's business spans 126 countries.

95% effective Sputnik vaccine

Sputnik has proven to be 95% effective in fighting corona during a trial. The second preliminary analysis of the clinical trial showed that 42 days after the first dose, it showed 95% efficacy. The data was 91.4% 28 days after the dose was given.It will also cost much less than other vaccines. People of Russia will get it for free. For other countries, its price will be less than 700 rupees.


Also Read|

US Plans to Starts Covid vaccinations by 11 December: Official

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World News/Covid-19 Vaccine traker: The united states hopes to start a sweeping program of Covid vaccinations in early December, the head of the govt coronavirus vaccine effort said Sunday.

"Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Moncef Slaoui told CNN.

"So I expect maybe on Day Two of the approval, on the 11th or the 12th of December."

FDA vaccine advisors reportedly will meet december 8 to 10 to discuss approving vaccines which Pfizer and Moderna say are a minimum of 95 percent effective.

Two leading vaccine candidates -- one by Pfizer and German partner BioNTech and another by US firm Moderna -- have shown to be 95 percent effective and Pfizer already applied to emergency use approval from US health authorities.

Meanwhile, Pfizer Inc applied to US health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application during a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer Chief executive officer Albert Bourla confirmed the application had been made in a video posted on the company's website on Friday afternoon.

The FDA said on Friday it might hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine.

Slaoui estimated that 20 million people across the US may be vaccinated in December, with 30 million per month after that.

US drug regulators on Saturday already gave emergency approval to a Covid-19 antibody therapy -- one used by US President Donald Trump -- and G20 nations were pushing for global "equitable" access to vaccines with worries poorer nations will be left behind.

The US, which recorded 177,552 new infections on Saturday, is now averaging almost 110,000 more daily cases than a month ago. Recently, US FDA approved an antibody cocktail from Regeneron Pharmaceuticals Inc. for coronavirus treatment.


Also Read|

Pfizer wants emergency use of its COVID-19 vaccine in US


Moderna vaccine 94.5% effective in preventing COVID-19: success gives world more hope

Pfizer wants emergency use of its COVID-19 vaccine in US

 The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease during a large, ongoing study.

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World News/Covid-19 Vaccine: Pfizer said Friday it's asking US regulators to permit emergency use of its COVID-19 vaccine, starting the clock on a process that might bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter. The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the ultimate testing is fully complete.

In addition to Friday's FDA submission, they have already started "rolling" applications in Europe and therefore the UK and intend to submit similar information soon.


With the coronavirus surging round the US and therefore the world, the pressure is on for regulators to make a speedy decision.

"Help is on the way," Dr Anthony Fauci, the top US infectious disease expert said on the eve of Pfizer's announcement, adding that it's too early to abandon masks and other protective measures. "We need to actually double down on the public health measures as we're waiting for that help to come."


Friday's filing triggers a sequence of events because the FDA and its independent advisers debate if the shots are ready. If so, still another government group will need to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

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How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.


About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of medicine this week. Recipients will need two doses, three weeks apart.


Also Read|

India’s Serum says produced 40 million doses of AstraZeneca COVID-19 vaccine

Pfizer says COVID-19 vaccine over 90% effective





Moderna vaccine 94.5% effective in preventing COVID-19: success gives world more hope


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World News/Covid-19 Vaccine: Moderna Inc’s experimental vaccine is 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, the company said on Monday, becoming the second U.S. drugmaker to report results that far exceed expectations.

Together with Pfizer Inc’s vaccine, which is also more than 90% effective, and pending more safety data and regulatory review, the United States could have two vaccines authorized for emergency use in December with as many as 60 million doses of vaccine available this year.

The vaccines, both developed with new technology known as messenger RNA (mRNA), represent powerful tools to fight a pandemic that has infected 54 million people worldwide and killed 1.3 million.

Unlike Pfizer’s vaccine, Moderna’s shot can be stored at normal fridge temperatures, which should make it easier to distribute, a critical factor as COVID-19 cases are soaring, hitting new records in the United States and pushing some European countries back into lockdowns.

“We are going to have a vaccine that can stop COVID-19,” Moderna President Stephen Hoge said in a telephone interview.

Moderna’s interim analysis was based on 95 infections among trial participants who received the vaccine or a placebo. Only five infections occurred in volunteers who received the vaccine mRNA-1273, which is administered in two shots 28 days apart.

“The vaccine is really the light at the end of the tunnel,” Dr. Anthony Fauci, the top U.S. infectious diseases expert said. He urged Americans not to let their guard down and to continue washing hands and being vigilant about social distancing.

Even with fast authorization, the vaccines will not come in time for most people celebrating the U.S. Thanksgiving and end-of-year holidays, when families and friends come together - just the types of gatherings public health officials warn against.

Moderna expects to have enough safety data required for U.S. authorization in the next week or so and expects to file for emergency use authorization (EUA) in the coming weeks.

The company’s shares, which have more than quadrupled this year, jumped 8%, while European and U.S. stocks rose. The benchmark S&P 500 rose 1%, while the pan-European STOXX 600 climbed 1.3%. [MKTS/GLOB]

Shares in Pfizer and its partner BioNTech, whose vaccine must be transported at far colder temperatures, fell 4.3% and 16.4% respectively, while Britain’s AstraZeneca, which has yet to release any results from its late-stage vaccine trials, was down 1%.


SEVERE CASES

Moderna’s data provide further validation of the promising but previously unproven mRNA platform, which turns the human body into a vaccine factory by coaxing cells to make virus proteins that the immune system sees as a threat and attacks.

Moderna expects the vaccine to be stable at normal fridge temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and it can be stored for up to 6 months at -20C.

Pfizer’s vaccine must be shipped and stored at -70C, the sort of temperature typical of an Antarctic winter. It can be stored for up to five days at standard refrigerator temperatures, or for up to 15 days in a thermal shipping box.

The data from Moderna’s trial involving 30,000 volunteers also showed the vaccine prevented cases of severe COVID-19, a question that still remains with the Pfizer vaccine. Of the 95 cases in Moderna’s trial, 11 were severe and all 11 occurred among volunteers who got the placebo.

Moderna, part of the U.S. government’s Operation Warp Speed program, expects to produce about 20 million doses for the United States this year, millions of which the company has already made and is ready to ship if it gets FDA authorization.

“Assuming we get an emergency use authorization, we’ll be ready to ship through Warp Speed almost in hours,” Hoge said. “So it could start being distributed instantly.”

The 95 cases of COVID-19 included several key groups who are at increased risk for severe disease, including 15 cases in adults aged 65 and older and 20 in participants from racially diverse groups.

“We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress, said Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine.

The trials were designed to measure whether the vaccines stop people from getting sick rather than whether they prevent transmission, which remains to be tested.

“It is likely that vaccines that prevent symptomatic disease will reduce the duration and level of infectiousness, and thus reduce transmission, but we don’t yet know if this effect will be large enough to make any meaningful difference to the spread of the virus within communities,” said Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh.


ROLLING REVIEW

Most side effects were mild to moderate. A significant proportion of volunteers, however, experienced more severe aches and pains after taking the second dose, including about 10% who had fatigue severe enough to interfere with daily activities while another 9% had severe body aches. Most of these complaints were generally short-lived, Moderna said.

“These effects are what we would expect with a vaccine that is working and inducing a good immune response,” said Peter Openshaw, professor of experimental medicine at Imperial College London.

The U.S. government, faced with the world’s highest known number of COVID-19 cases, could have access next year to more than 1 billion doses from Moderna and Pfizer, more than needed for the country’s 330 million residents.

The Trump Administration has mainly relied on the development of vaccines and treatments as its response to the pandemic. Moderna has received nearly $1 billion in research and development funding from the U.S. government and has a $1.5 billion deal for 100 million doses. The government has an option for another 400 million doses.

The company hopes to produce between 500 million and 1 billion doses in 2021, split between its U.S. and international manufacturing sites, depending in part on demand.

Europe’s health regulator said on Monday it had launched a real-time “rolling review” of Moderna’s vaccine, as it has done for vaccines from Pfizer and AstraZeneca. Brussels also said it was in talks with Moderna about securing doses.

Other countries such as China and Russia have already begun vaccinations. Russia licensed its Sputnik-V COVID-19 vaccine for domestic use in August before it started large-scale trials. It said on Nov. 11 that its vaccine was 92% effective based on 20 infections in its large trial.

News Source: Reuters


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India’s Serum says produced 40 million doses of AstraZeneca COVID-19 vaccine

Pfizer says COVID-19 vaccine over 90% effective


India’s Serum says produced 40 million doses of AstraZeneca COVID-19 vaccine

 India’s Serum Institute has said it's made 40 million doses of AstraZeneca's potential Covid-19 vaccine. The ICMR will pursue "early availability" of the shot in India, it added.

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Latest News/Covid-19 Vaccine/Corona Virus Vaccine Update: Serum Institute of India, the world's largest vaccine producer, has said it's made 40 million doses of AstraZeneca's potential Covid-19 vaccine, and can soon begin making Novavax's rival shot, as they both seek regulatory approval.

Serum on Thursday said it had enrolled 1,600 participants in India for late-stage trials of AstraZeneca's candidate, and also plans to seek regulatory approval to run late-stage trials for the Novavax vaccine.

The AstraZeneca vaccine, co-developed by Oxford University , is that the most advanced in human testing in India, Serum said, adding that the company and therefore the Indian Council of Medical Research (ICMR) will pursue "early availability" of the shot in India.

Representatives for both Serum and therefore the ICMR declined to comment on whether the 40 million doses of the AstraZeneca vaccine were meant for supply only in India. 

The ICMR, a federal government body, had funded the clinical trial site fees for the AstraZeneca vaccine, Serum said. The company and therefore the ICMR are currently conducting mid-stage clinical trials of the shot at 15 centres across India.

The news came as coronavirus infections in India, the world's second-worst hit country, reached 8.68 million on Thursday and therefore the death toll increased to over 128,000.

India also has at least two home-grown Covid-19 vaccine candidates in development, while local drugmaker Dr Reddy's Labs is carrying out a trial within the country for Russia's vaccine candidate.

Earlier in the week , Pfizer and its partner BioNTech said their vaccine candidate had proven over 90% effective based on initial trial results. Pfizer said it had been committed to advancing its engagement with India's government to supply its potential vaccine within the country.


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Pfizer says COVID-19 vaccine over 90% effective

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Coronavirus Vaccine Tracker/ World News: Pfizer Inc's (PFE.N) experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world's economy.

Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.

Pfizer and German partner BioNTech SE (22UAy.F) said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

"Today is a great day for science and humanity," said Pfizer Chief Executive Albert Bourla.

"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen," he said.

Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.

"This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general," said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the "new normal" of social distancing and face covering set to remain for the foreseeable future.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study's 44,000 participants, which is expected in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.


MARKETS SURGE

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video (ZM.O) and online retailers, tumbled.

Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech's stock hit a record high.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson (JNJ.N) up 4% and Moderna Inc (MRNA.O), whose vaccine uses a similar technology as the Pfizer shot, up 8%. Britain's AstraZeneca (AZN.L), however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.

"The efficacy data are really impressive. This is better than most of us anticipated," said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. "The study isn't completed yet, but nonetheless the data look very solid."

U.S. President Donald Trump welcomed the test results, and the market boost: "STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!" he tweeted.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

The World Health Organization said the results were very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.


'NEAR ECSTATIC'

"I'm near ecstatic," Bill Gruber, one of Pfizer's top vaccine scientists, said in an interview. "This is a great day for public health and for the potential to get us all out of the circumstances we're now in."

Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany's health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.

The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.

The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration's Operation Warp Speed vaccine program.

The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.

Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not break down how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

Shortly after Pfizer's announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.

MORE DATA NEEDED

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.

Pfizer said its data would be peer reviewed once it has results from the entire trial.

"These are interesting first signals, but again they are only communicated in press releases," said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.

News source: Reuters


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Covid-19: China gives ‘unproven’ vaccine to thousands of people, makes them sign ‘secrecy’ agreement

 Thousands of Chinese have already been inoculated by Covid-19 vaccines which are still under trial. China has said WHO gave them a go-ahead.

covid-19,World Health Organization,Covid-19 vaccine,CHINA,China gives ‘unproven’ vaccine to thousands,WHO,Coronavirus vaccine,Coronavirus Vaccine Tracker,
Little is known about China’s Covid-19 vaccination programme. (REUTERS)

China is injecting thousands of its people with Covid-19 vaccine shots, which are still under trial and hence their efficacy unproven, reports said. people who are getting these vaccine shots are made to sign a “nondisclosure agreement”, according to which they can’t talk about it to the news media.

High-risk population, including staff of state-owned companies, government officials, vaccine company staff, teachers are being inoculated on an emergency basis. Global heath experts are raising questions whether their consent has are being taken or not.


In its defence, China has said that the world Health Organization supported China’s experimental coronavirus vaccine programme, which started in July. China informed WHO in June, Zheng Zhongwei, a National Health Commission official, told Reuters.


WHO chief scientist Soumya Swaminathan has said countries can approve use of medical products within their own jurisdiction in the current emergency situation but only as a “temporary solution”.


China currently has 11 vaccines in clinical trials and four in Phrase 3 trials.Among these. two are developed by state-backed China National Biotec Group and one by Sinovac Biotech. Another experimental vaccine was developed by CanSino Biologics, which was approved to be used in the Chinese military in June.


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PM Narendra Modi pledges to use India vaccine-production capacity to help 'all humanity'

 Indian Prime Minister Narendra Modi pledged at the United Nations on Saturday that his country’s vaccine production capacity would be made available globally to fight the COVID-19 crisis.

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“As the largest vaccine-producing country of the world, i want to give one more assurance to the global community today,” Modi said during a pre-recorded speech to the U.N. General Assembly. “India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis.”


Modi said India was moving ahead with Phase 3 clinical trials - the large-scale trials considered the gold standard for determining safety and efficacy - and would help all countries enhance their cold chain and storage capacities for the delivery of vaccines.


Modi said in August that India was able to mass produce COVID-19 vaccines when scientists gave the go-ahead.


U.N. chief Antonio Guterres has been pushing for a “people’s vaccine” that's available and affordable everywhere and expressed concern on Tuesday that some countries were “reportedly making side deals exclusively for their own populations.”

“Such ‘vaccinationalism’ is not only unfair, it is self-defeating. None of us is safe until all of us are safe. Everybody knows that,” he told the general Assembly


Australian Prime Minister Scott Morrison told the general Assembly on Friday: “Whoever finds the vaccine must share it.”


“Some might see short- term advantage, or even profit,” Morrison said. “But I assure you to anyone who may think along those lines, humanity will have a very long memory and be a very, very severe judge.


“Australia’s pledge is clear: if we find the vaccine we will share it. That’s the pledge we all must make,” Morrison said.

Pope Francis told the United Nations on Friday that the poor and weakest members of society should get preferential treatment when a coronavirus vaccine is ready.


India, the world’s second most populous country after China, has recorded more than 5.8 million cases of COVID-19, second only behind the united states.


Its death toll as of in the week was more than 90,000 and it has consistently reported the highest tally of daily cases anywhere within the world as a dense population and sometimes rudimentary healthcare infrastructure hamper attempts to control the pandemic.


News Source : Reuters


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Oxford Vaccine Trials to Resume In UK, Were Paused Over Volunteer's Illness

 Study restarts after halt to assess participant’s illness.No word from Astra or Oxford on status of separate U.S. trial.

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The University of Oxford and AstraZeneca Plc have restarted a U.K. trial of an experimental Covid-19 vaccine after it had been halted over concerns about a participant who fell ill.

The U.K. Medicines Health regulatory authority recommended that the study resume after an independent review of the safety data triggered an interruption on Sept. 6, Oxford said in a statement. It declined to disclose details about the volunteer’s illness.


While temporary halts are common in vaccine trials, the interruption to the closely watched Astra-Oxford study had raised concerns about the viability of one of the fastest-moving experimental shots seeking protection from the pandemic. The race to develop a Covid-19 vaccine has compressed what's normally a decade-long process into a matter of months, with data from final-stage trials expected as soon as next month.


Statements from Astra and Oxford on Saturday didn’t say anything about the status of tests outside the U.K. Trials of the Oxford vaccine were underway within the U.S., Brazil, South Africa and India before being paused after the safety review.



A representative for the U.S. National Institutes of Health couldn’t immediately be reached for comment. An AstraZeneca spokesman declined to comment.


Suspected Diagnosis

AstraZeneca Chief executive officer Pascal Soriot said on Thursday that the vaccine could still be available by the end of the year. An independent safety board was reviewing whether the participant’s illness had been caused by the vaccine or was unrelated, he said.


Soriot said it wasn’t clear whether the participant had a condition called transverse myelitis, a suspected diagnosis. NIH Director Francis Collins told a Senate committee Wednesday the trial had been halted due to a “spinal cord problem.”

“We cannot disclose medical information about the illness for reasons of participant confidentiality,” Oxford said. “We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”


Oxford said some 18,000 people have received “study vaccines” as a part of the trials. It had begun a large phase 3 trial within the U.S. at the end of August, with the aim of enrolling 30,000 people.


AstraZeneca is one among several companies participating within the U.S. government’s Operation Warp Speed program to fast-track a coronavirus vaccine. In May, the company inked a $1.2 billion deal with the U.S. to support clinical studies and provide 300 million doses of the vaccine. it's pledged to provide the vaccine on a not-for-profit basis during the pandemic and has lined up deals round the world to supply almost 3 billion doses.


Human Trials

Oxford began human trials of its shot on April 23 in almost 1,100 volunteers and at the end of May advanced quickly to a large-scale study within the U.K. involving more than 10,000 people including those over the age of 55. Researchers are looking for a significantly higher number of Covid-19 cases within the control group over the vaccinated group to show the shot is effective.


The trial started even as rates of infection within the U.K. began dropping in May, making it harder to demonstrate whether the vaccine works. In recent weeks, new cases are climbing again.


In July, Oxford reported initial results showing the vaccine increased levels of protective neutralizing antibodies and immune T-cells that target and destroy infected cells. It didn’t report any serious adverse events as a part of its phase 1-2 trial. Researchers pressed ahead with trialing a two-dose regime after finding it produced a stronger response in 10 volunteers. It’s unclear whether the participant who fell ill had two doses or one.



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Covid-19 vaccine distribution not expected until mid-2021: WHO chief scientist

 None of the candidate vaccines in advanced clinical trials thus far has demonstrated a "clear signal" of efficacy at the extent of a minimum of 50% sought by the WHO, spokeswoman Margaret Harris said.



The World Health Organization doesn't expect widespread vaccinations against COVID-19 until the center of next year, a spokeswoman said on Friday, stressing the importance of rigorous checks on their effectiveness and safety.

None of the candidate vaccines in advanced clinical trials thus far has demonstrated a "clear signal" of efficacy at the extent of a minimum of 50% sought by the WHO, spokeswoman Margaret Harris said.


Russia granted regulatory approval to a COVID-19 vaccine in August after less than two months of human testing, prompting some Western experts to question its safety and efficacy.

US public health officials and Pfizer Inc said on Thursday a vaccine might be ready for distribution as soon as late October. That might be just before the US election on Nov. 3 during which the pandemic is probably going to be a serious factor among voters deciding whether President Donald Trump wins a second term.


"We are really not expecting to see widespread vaccination until the middle of next year," Harris told a UN briefing in Geneva.

"This phase 3 must take longer because we need to see how truly protective the vaccine is and that we also need to see how safe it is," she added. This mentioned the introduce vaccine research where large clinical trials among people are conducted. Harris didn't ask any specific vaccine candidate.


All data from trials must be shared and compared, Harris said. "A lot of people have been vaccinated and what we don't know is whether the vaccine works...at this stage we do not have the clear signal of whether or not it's the level of worthwhile efficacy and safety...," she added.

The WHO and GAVI vaccine alliance are leading a worldwide vaccine allocation plan referred to as COVAX that aims to assist buy and distribute shots fairly. the main target is on first vaccinating the foremost high-risk people in every country like healthcare workers.


COVAX aims to acquire and deliver 2 billion doses of approved vaccines by the top of 2021, but some countries that have secured their own supplies through bilateral deals, including the us , have said they will not join.

"Essentially, the door is open. We are open. What the COVAX is about is making sure everybody on the planet will get access to the vaccines," Harris said.


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Pfizer CEO says COVID-19 vaccine likely to be ready by October this year

  •  Pfizer has enrolled 23,000 patients in vaccine tests as of Wednesday
  • Pfizer has said it’s on target to possess enough data for an authorization as early as October.


Pharma giant Pfizer is probably going to offer update on its Covid-19 vaccine by October-end on whether a COVID-19 vaccine (BNT162b2) it's developing is successful, and can submit it for approval immediately if that's the case, consistent with reports.


Pfizer has enrolled 23,000 patients in vaccine tests as of Wednesday, its Chief Executive Albert Bourla said in an online briefing sponsored by drug industry group International Federation of Pharmaceuticals Manufacturers & Association, reported Reuters.

Pfizer has said it’s on target to possess enough data for an authorization as early as October. based on how quickly and where it’s currently recruiting people for its 30,000-person trial, it'll probably be the primary US drugmaker with interim data, by October 15, but won’t have full results until November 17, Airfinity projects, consistent with Bloomberg reports.


The pharmaceutical company has already manufactured many thousands of doses of the vaccine candidate, including at a plant in Belgium, Bourla added. it's within the race to come up with a vaccine with its partner, Germany's BioNTech.

The US Centers for Disease Control and Prevention (CDC) has asked state public health officials to organize to distribute a possible coronavirus vaccine to high-risk groups as soon as late October, documents published by the agency showed on Wednesday.


Meanwhile, companies testing vaccines within the U.S., where the virus has spread more quickly than in Europe for the past several months, may have a plus in potential volunteers and infections. AstraZeneca said it expects results later this year, counting on the speed of infection within the communities where it’s running trials. J&J said it still plans to start out its late-stage trial this month, with first batches of vaccine available for potential emergency use in early 2021, pending the study results. Sinovac declined to comment. Moderna declined to discuss the time-frame for its data readouts.


The drugmakers have already made deals to provide many many doses to governments round the world.

The WHO has said any vaccine should be shown to be effective in a minimum of half the people who get it to gain clearance. it'll be important to follow participants within the trials long enough to ascertain whether serious side effects emerge, WHO Chief Scientist Soumya Swaminathan said on Monday. A premature approval would make it hard to continue studying the vaccine in randomized trials, she said. The agency counts 176 Covid-19 vaccines in development, of which 33 have entered human trials.


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Serum Institute says reports of Covid-19 Vaccine Covishield vaccine availability in 73 days false


COVISHIELD will be commercialised only after trials are proven successful and all the requisite regulatory approvals are in place.



Serum Institue of India (SII) issued a press release on August 23, clarifying that each one claims surrounding the supply of its COVID-19 vaccine,COVISHIELD, in 73 days are false.

"Presently, the government has granted us permission to only manufacture the vaccine and stockpile it for future use," SII said during a statement they posted on Facebook, adding that COVISHIELD are going to be commercialised only after trials are proven successful and in any case the requisite regulatory approvals are in situ .

The company also took to Twitter to line the record straight:
SII also touched on the Oxford-AstraZeneca vaccine. "The phase-3 trials for the Oxford-AstraZeneca vaccine are still underway. And only once the vaccine is proven immunogenic and efficacious, SII will confirm its availability, officially," the corporate said.

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73 days to COVID-19 vaccine; Indians to get free shots

 


India's first Covid vaccine-Serum Institute's 'Covishield'- are going to be commercialised in 73 days. Indians are going to be immunised free under the National Immunisation Programme (NIP) as is that the case with all other vaccines under the programme.


"The government has given us a 'special manufacturing priority license' and fast-tracked the trial protocol processes to get the trials completed in 58 days. By this, the first dosing is happening from today in the final phase (Phase III) and the second dosing will happen after 29 days. the final trial data will be out in another 15 days from the second dosing. By that time, we are planning to commercialise Covishield," a Serum Institute of India (SII) top official exclusively revealed.


Earlier, the third phase trials were expected to require a minimum 7-8 months.


The trial among 1600 volunteers at 17 centres, each with about 100 volunteers, started on Aug 22.


Union Health Minister Harsh Vardhan has also said that one among our COVID-19 vaccine candidates is within the third phase of the clinical test . "We are very confident that a vaccine will be developed by end of this year," he said.


The source said the vaccine will belong to Serum Institute, because the company has entered into an exclusive agreement with Astra Zeneca to shop for rights and pay a royalty fee for exclusively selling it in India and 92 other countries. The central government has already indicated to SII that it'll directly procure the vaccines and is getting to immunise Indians for free of charge . Centre has sought 68 crore doses for 130 crore Indian citizens from Serum Institute by June, next year.

For the rest, it's likely to put orders with 'Covaxine' being developed by ICMR and Bharat Biotech and Zydus Cadila's 'ZyCoV-D' if their trials proceed successfully.


Bharat Biotech is yet to point when it might start and finish the trials, though Bharat Biotech's CMD Krishna Ella had said that to make sure safety and efficacy it might not expedite the vaccine with short-cuts.


Serum is beginning to manufacture 6 crore doses per month which can be increased to 10 crore per month by April, 2021. this is often being done by re-engineering its vaccine manufacturing lines that it's spent nearly Rs 200 crore. SII, the most important vaccine maker within the world, features a capacity to form 150 crore doses a year.


The Bill & Melinda Gates Foundation has agreed to fund Serum with about $150 million (nearly Rs 1125 crore) to supply and provide around 10 crore doses of Covid-19 vaccine for supply to low income countries. which will help SII to scale back the worth to about Rs 250 per dose from over Rs 1,000 per dose, the source said.


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