SII’s Covishield approved by India: Efficacy, cost and all about AstraZeneca’s Covid-19 vaccine

AstraZeneca had signed an agreement with Serum Institute of India (SII) to produce 1 billion doses of its experimental vaccine for low- and middle-income countries.

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India News/ Covid-19 Vaccine Tracker: A government’s expert panel has reportedly approved the vaccine, developed by AstraZeneca and Oxford University, for emergency use in India to provide immunity against the coronavirus disease (Covid-19). According to news agency Reuters, a subject expert committee, set up by Drugs Controller General of India (DCGI) to vet Covid-19 vaccine proposals, recommended granting emergency use authorisation to AstraZeneca’s vaccine AZD1222, dubbed in India as Covishield.

AstraZeneca had signed an agreement with Serum Institute of India (SII) to produce 1 billion doses of its experimental vaccine for low- and middle-income countries. The Pune-based company has sought an emergency use authorisation for the Covid-19 vaccine which recently received approval from British regulators.

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Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday authorised the AstraZeneca-Oxford vaccine for deployment across the United Kingdom on the conditions that the vaccine should be administered in two doses, with the second dose given between 4 and 12 weeks after the first.

Here’s all you need to know about the vaccine:

Efficacy: In two different dosing regimens, the AstraZeneca-Oxford Covid-19 vaccine showed the efficacy of 90 per cent and 62 per cent. In participants who received two full doses at least one month apart, vaccine efficacy was 62 per cent, and in participants who received a low dose followed by a full dose, efficacy was 90 per cent.

Also Read|India may approve AstraZeneca vaccine by next week

Safety: The Lancet publication, a leading medical journal, has confirmed that AZD1222 was well tolerated and there were no serious safety events confirmed related to the vaccine. The safety data published is from over 20,000 participants, so far, enrolled across four clinical trials in the UK and Brazil and South Africa.

Storage: The AstraZeneca-Oxford Covid-19 vaccine can be stored, transported and handled at normal refrigerated conditions (2°C to 8°C) for at least six months.

Cost: Adar Poonawalla, the chief executive officer of SII, had told Hindustan Times that Covidshield will be priced in India at Rs 500-600.

Also Read| SII’s Covishield approved by India: Efficacy, cost and all about AstraZeneca’s Covid-19 vaccine

Technology: AZD1222 is made of a weakened and modified version of adenovirus (a common cold virus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

News Source: Hidustan Times

California Nurse Tested Positive for Covid-19 a week after receiving Pfizer-BioNtech's Vaccine

 Matthew W, a nurse at two different local hospitals, said in a Facebook post on December 18 that he had received the Pfizer vaccine, telling the ABC News affiliate that his arm was sore for a day but that he had suffered no other side-effects.

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World News / Covid-19 Vaccine Tracker : A 45-year-old nurse in California tested positive for COVID-19 more than a week after receiving Pfizer Inc's coronavirus vaccine, an ABC News affiliate reported on Tuesday.

Matthew W, a nurse at two different local hospitals, said in a Facebook post on December 18 that he had received the Pfizer vaccine, telling the ABC News affiliate that his arm was sore for a day but that he had suffered no other side-effects.

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Six days later on Christmas Eve, he became sick after working a shift in the COVID-19 unit, the report added. He got the chills and later came down with muscle aches and fatigue.

He went to a drive-up hospital testing site and tested positive for COVID-19 the day after Christmas, the report said.

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Christian Ramers, an infectious disease specialist with Family Health Centers of San Diego, told the ABC News affiliate that this scenario was not unexpected.

"We know from the vaccine clinical trials that it's going to take about 10 to 14 days for you to start to develop protection from the vaccine," Ramers said.

Also Read| India may approve AstraZeneca vaccine by next week

"That first dose we think gives you somewhere around 50%, and you need that second dose to get up to 95%," Ramers added.

News Source: Reuters

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.

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.

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"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.

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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.

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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.

Uk Watchdog issued allergy warning for Pfizer Covid-19 Vaccine

 UK's Medicines and Healthcare products regulatory agency issued the advisory after two NHS workers developed allergies shortly after receiving the Pfizer vaccine; they're stable now.

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World News/Covid-19 Vaccine Tracker: British healthcare regulator has issued a warning that individuals with history of serious allergies shouldn't be given the newly approved Pfizer-BioNTech COVID-19 vaccine. The advisory was issued after two NHS workers suffered allergic reactions on Tuesday.

Medicines and Healthcare products regulatory agency (MHRA) said that the allergy advisory applies to people that have had reactions to medicines, food or vaccines, reported the BBC.

Dr June Raine, chief executive of MHRA, informed a parliamentary committee on Wednesday that the cases of severe allergic reactions didn't appear during vaccine trials. "We know from the very extensive clinical trials that this wasn't a feature. But if we need to strengthen our advice, now that we've had this experience in the vulnerable populations - the groups have been selected as a priority - we get that advice to the field immediately," said Dr Raine.

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The two UK healthcare workers reportedly developed anaphylactoid reaction shortly after the Pfizer COVID-19 vaccine was administered to them, the report said. They received treatment shortly after, and are stable now.

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

Anaphylactoid reactios appear as skin rashes, breathlessnes and a drop in blood pressure. this is often different from anaphylaxis, which may cause death.

Notably, both individuals have prior history of allergies and carried adernaline pens for fiirst aid within the event of severe reactions.

The Pfizer-BioNTech jab, codenamed BNT162b2, became the first ever vacccine against coronavirus to receive emergency use approval - first in the UK then in Bahrain. the companies have also approved regulators in India for emergency use authorisation of the inoculation, but it seems like a long shot, considering the very fact it's never underwent any trials within the country. The vaccine has got to be stored at extremely frigid temperatures of -70 degree Centigrade , which presents another argument against its appoval by the Indian regulator.

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

Meanwhile, the united kingdom has began to vaccinate its priority groups against COVID-19 using the Pfizer vaccine. Margaret Keenan, 90, and Shakespeare , 81, were the first and second recipients of the jab vaccine in the world. British government intends to administer 800,000 in the coming weeks.