India may approve AstraZeneca vaccine by next week

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Covid-19 Vaccine Tracker/India News:  India is probably going to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.

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This could be the first country to give the regulatory green light for British drugmaker’s vaccine because the British medicine regulator continues to look at data from the trials.

India, the world’s biggest vaccine-making country, wants to start out inoculating its citizens next month and is additionally considering emergency use authorisation applications for vaccines made by Pfizer Inc and native company Bharat Biotech.

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Getting vaccines to the world’s second-most populous country with one among the very best infection rates also will be an enormous step within the battle against the pandemic.

The AstraZeneca-Oxford shot is taken into account vital for lower-income countries and people in hot climates because it's cheaper, easier to move and may be stored for long periods at normal fridge temperatures.

India's Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on Dec. 9 here and sought more information from all the businesses , including from Serum Institute of India (SII), which is making the AstraZeneca shots.

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SII, the world's biggest vaccine manufacturer, has now provided all the info , the 2 sources said. The authorities were still expecting more details from Pfizer, a government health adviser told here a news briefing on Tuesday, while one among the sources said additional information was expected from Bharat Biotech.

Both sources said Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot which there have been “strong indications” an approval would come by next week.

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The expected approval comes after data from AstraZeneca’s late-stage trials within the UK and Brazil released earlier this month showed the vaccine had efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.

The Indian regulator is merely considering the 2 full-dose regimen of the shot despite it showing a lower success rate, the sources said.

“Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.”

The sources declined to be named as deliberations were ongoing and therefore the timeline could change.

CDSCO chief V.G. Somani didn't immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII didn't immediately answer an email seeking comment.

India has not yet signed a vaccine supply affect any company, but SII has already stockpiled quite 50 million doses of the AstraZeneca shot and plans to form a complete of 400 million doses by July.

Pfizer wants approval for emergency use in India after UK

 Pfizer Inc submitted application to DCGI seeking emergency use authorisation on Dec 4; also seeks permission to import vaccine for sale and distribution in India.

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World News/Covid-19 Vaccine Tracker: Pfizer has become the primary company to seek emergency use approval of its vaccine candidate in India after getting clearance within the UK and Bahrain. Pfizer Inc and BioNTech SE vaccine candidate, BNT162b2, has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. It's sought approval from the Drugs Controller General of India for emergency use authorisation. the development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to mention that India could have the first coronavirus vaccine in weeks and that eight vaccines are going to be manufactured in India.

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Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to urge instant approval for emergency use, a PTI report said.

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"Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India," an official source told the press agency .

AIIMS Delhi Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its COVID-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental COVID-19 vaccine.

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The UK became the first country within the world to approve Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products regulatory agency (MHRA) found the jab safe. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the united kingdom , Bahrain has also approved the vaccine for 'emergency use'. Bahrain's drug regulatory body said the approval was granted after a radical analysis and review of all available data.

The approval for Pfizer's vaccine candidate came in just 10 months since it started developing it, which is that the fastest within the history of vaccines. Other countries just like the US and the European Union also are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc. 

Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the sole vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes. Besides, Swedish drugmaker AstraZeneca and therefore the University of Oxford's vaccine candidate, being developed along side India's Serum Institute, has also achieved 70 per cent efficacy during the preliminary analysis of its Covid-19 trial participants.

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.

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US Plans to Starts Covid vaccinations by 11 December: Official

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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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.

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 trial AstraZeneca CEO says, participant had serious neurological symptoms, but could be discharged today

 COVID-19 VACCINE TRIAL PARTICIPANT HAD SERIOUS NEUROLOGICAL SYMPTOMS, BUT might be DISCHARGED TODAY, ASTRAZENECA CEO SAYS 

The participant who triggered a worldwide shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a lady in the uk who experienced neurological symptoms according to a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a personal call with investors on Wednesday morning.

The woman’s diagnosis has not been confirmed yet, but she is improving and can likely be discharged from the hospital as early as Wednesday, Soriot said.

The board tasked with overseeing the info and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the call , which was found out by the investment bank J.P. Morgan.

Soriot also confirmed that the clinical test was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with MS , deemed to be unrelated to the Covid-19 vaccine treatment, he said.

The new disclosures made by Soriot were heard by three investors participating on the decision and were shared with STAT. An AstraZeneca spokesperson didn't answer an email request for further comment.

One investor on the decision said Soriot’s comments were intended to reassure investors that the corporate was taking the possible vaccine safety event seriously, and to reverse any damage to the company’s stock price. “A vaccine that nobody wants to take is not very useful,” said Soriot.

To date, AstraZeneca’s public statements on the pause are sparse with details. as an example , the corporate has not publicly confirmed that this is often the second time its trials are stopped to research health events among participants.

On Wednesday, the corporate issued a press release , attributed to Soriot, saying AstraZeneca would be guided by a committee of independent experts in determining when to lift the hold on the trial “so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

AstraZeneca’s is that the first Phase 3 Covid-19 vaccine trial known to possess been placed on hold. Such holds aren't uncommon, and it’s not clear yet how long AstraZeneca’s will last.

“To have a clinical hold, as has been placed on AstraZeneca as of yesterday, because of a single serious adverse event is not at all unprecedented,” Francis Collins, the director of the National Institutes of Health, told a Senate panel on Wednesday. “This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, some of them may get ill and you always have to try to figure out: Is that because of the vaccine, or were they going to get that illness anyway?”

AstraZeneca only began its Phase 3 trial within the U.S. in late August. The U.S. trial is currently happening at 62 sites across the country, consistent with clinicaltrials.gov, a government registry, though some haven't yet started enrolling participants. The Phase 3 trial within the U.S. aims to enroll about 30,000 participants at 80 sites across the country, consistent with a release last week from the NIH. Phase 2/3 trials were previously started within the U.K., Brazil, and South Africa .

The vaccine — referred to as AZD1222 — uses an adenovirus that carries a gene for one among the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is meant to induce the system to get a protective response against SARS-2. The platform has not been utilized in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus .

Transverse myelitis may be a serious condition involving inflammation of the medulla spinalis which will cause muscle weakness, paralysis, pain and bladder problems. In rare instances, vaccines have triggered cases of transverse myelitis; although it also can be caused by viral infections.

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Trials Of Oxford Vaccine "Put on hold" After Unexpected Illness In Volunteer

Trials Of Oxford Vaccine "Put on hold" After Unexpected Illness In Volunteer

 AstraZeneca, which is developing the drug alongside the University of Oxford, may be a frontrunner within the global race for a Covid-19 vaccine.

Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.

The company, which is developing the drug alongside the University of Oxford, may be a frontrunner within the global race for a Covid-19 vaccine.

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen accidentally but must be reviewed independently.

"We are working to expedite the review of the single event to minimise any potential impact on the trial timeline," the spokesperson added.

It was not immediately clear where the patient was, or the character and severity of their illness.

Holds during clinical trials aren't uncommon, but this is often thought to be the primary time it's happened for a Covid-19 vaccine trial.

AstraZeneca is one among nine companies currently in late-stage Phase 3 trials for his or her vaccine candidates.

In the US, the corporate began enrolling 30,000 volunteers across dozens of web sites on August 31.

The vaccine, called AZD1222, uses a weakened version of a standard cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the physical body , which primes the system to attack the coronavirus if the person is later infected.

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