In the backdrop of Pfizer and BioNTech saying their Covid-19 vaccine was found 95 per cent effective in the final analysis of the Phase 3 trial and Moderna announcing that its vaccine has shown to be 94.5 per cent effective, top US health expert has said their data looks ‘solid’.
Dr Anthony Fauci, United States' top infectious disease official, said on Thursday that two coronavirus vaccines being tested were solid and that the speed at which they were developed has not compromised safety or integrity.
“The process of the speed did not compromise at all safety nor did it compromise scientific integrity. It was a reflection of the extraordinary scientific advances in these types of vaccines which allowed us to do things in months that actually took years before,” Dr Anthony Fauci told AFP.
After speed at which the vaccines have been developed raised alarm, the health expert said, “It was actually an independent body of people who have no allegiance to anyone -- not to the administration, not to me, not to the companies -- that looked at the data and deemed it to be sound. So we need to put to rest any concept that this was rushed in an inappropriate way. This is really solid.”
Pfizer-BioNTech to seek emergency vaccine approval
The US government and BioNTech's co-founder have said that an emergency use authorisation request for the Covid-19 vaccine developed by Pfizer and BioNTech could be filed with the FDA on Friday.
"Pfizer's partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA," health secretary Alex Azar told a press conference Thursday.
This type of Food and Drug Administration authorisation is temporary or conditional and is granted in response to an emergency situation such as a pandemic. The FDA, however, did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria.
The BioNTech/Pfizer shot and another one being developed by US firm Moderna took the lead in the global chase for a vaccine, after large-scale trial data this month showed that their jabs were around 95 percent effective against Covid-19.
The twin breakthroughs lifted hopes for an end to a pandemic that has infected more than 56 million people and caused over 1.3 million deaths worldwide since the virus first emerged in China late last year.
India’s Serum Institute chief says Oxford vaccine should be available for public by April
Serum Institute of India's CEO Adar Poonawalla has said the Oxford Covid-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public.
The SII chief said the Oxford vaccine will be priced at a maximum of Rs 1,000 for two necessary doses for the public.
"It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," SII’s Adar Poonawalla said.
On price of the shots, Serum Institute chief said, “The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what Covax has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today.”
On the efficacy of the vaccine, Adar Poonawalla said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people. "It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Poonawalla said.
Asked when the SII will apply for an emergency authorisation, Poonawalla said as soon as the UK authorities and the European Medicines Evaluation Agency (EMEA) approve it for emergency use, it will apply to the drug controller for emergency use authorisation in India.
"But that will be for a limited use for frontline workers, healthcare workers and elderly people," he added.
Children would have to wait a little longer till the safety data is out, but the good news is that covid-19 is not so bad and serious for them, Poonawalla said.
Poonawalla said the Oxford vaccine is affordable, safe and stored at a temperature of two to eight degrees Celsius, which is an ideal temperature for it to be stored in the cold storages of India. He said the SII plans to make about 10 crore doses per month from February.
On how many doses would be provided to India, Poonawalla said talks are still going on and no agreement has been arrived at in this regard.
"India wants around 400 million doses by July. I do not know if it will take all from the Serum Institute. We are gearing up to offer that kind of volume to India and still have a few 100 million to offer to COVAX by July and August. No agreement so far," he said.
Poonawalla said 30-40 crore doses of the Oxford vaccine will be available by the first quarter of 2021.
2 vaccines could be authorised soon, says EU official
The European Union's top official said that two Covid-19 vaccines could receive conditional market authorisation as early as the second half of December.
European Commission president Ursula von der Leyen said the vaccines developed by Moderna and Pfizer, which created its serum with German drugmaker BioNTech, could be approved by the end of the year by the European Medicines Agency (EMA) “if all proceeds now without any problem.”
Von der Leyen added: “This is the very first step to be able to be on the market.”
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