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Covid-19 vaccine tracker, Sept 4: Pfizer steps up the heat, says will know about effectiveness of its shot by October

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Pharmaceutical giant Pfizer has said it would seek emergency use authorisation for its coronavirus vaccine from the US Food and Drug Administration, once it was established that the vaccine was indeed effective. The company said this could happen as early as the end of next month, and it intended to apply for emergency license immediately after that, according to a report in The New York Times.

Pfizer’s vaccine, being developed in collaboration with German partner BioNTech, is currently undergoing third and last stage of clinical trials. Its chief executive Albert Bourla said about 23,000 volunteers had been enrolled for the stage-3 trials, and many of them had been administered the second booster dose as well. He said the company would know “in October time frame” how effective the vaccine had been on the volunteers. He said if the effectiveness data was good, the company would immediately apply for emergency use authorisation. Read in Malayalam

FDA, the US drug regulator, has indicated that it would be open to considering applications for emergency use authorisation for coronavirus vaccines, even if the phase-3 clinical trials had not been completed. Pfizer is the first vaccine developer to explicitly state that it intended to seek an emergency approval.

Pfizer’s statement is expected to further heat up an already crazy race for a coronavirus vaccine. In the last few days, it has become evident that a vaccine would be made available this year itself. Before this the most optimistic timeline being talked about was early next year.

But the US Presidential elections on November 3 could playing its part in expediting the vaccine development even further. US President Donald Trump has repeatedly stated that the vaccine could indeed be made available this year itself. He also accused FDA of harbouring a “deep state” that was deliberately delaying the approval process, apparently to sabotage his re-election chances. Trump is seeking a re-election in November 3 polls, and the availability of a coronavirus vaccine before that is seen to be boosting his chances.

Trump has publicly said that a vaccine before November 3 could not be ruled out. The developments of last few days would suggest that everyone was working to make that possible. After the FDA said it would consider approving a vaccine for emergency use, if the benefits outweighed the risks, the Centres of Disease Control and Prevention told public health officials across the US to be prepared for a vaccination programme for targeted groups by late October or early November.

Even Dr Anthony Fauci, America’s most famous expert on coronavirus who has repeatedly said he expected a vaccine to be ready only by early next year, seemed to be getting around the view that an early introduction of vaccine was possible, and in the interests of the people. In several interviews in the last couple of days, Fauci has been saying that if early data from phase-3 trials were promising enough, the vaccine could be cleared for emergency use on high-risk groups like health workers.

Pfizer’s announcement could force other developers to speed up and target the same time-frame. Two other leading contenders, one being developed by Moderna and the other by Oxford University and AstraZeneca, are also undergoing phase-3 clinical trials, and are roughly at the same stage as Pfizer’s candidate.

New study reaffirms safety of Novavax vaccine

A new study published in the New England Journal of Medicine says a coronavirus vaccine candidate being developed by Novavax, a US-based biotechnology company, “appeared to be safe” in the phase-1 clinical trials carried out in May. The company had announced these results earlier, but the results have been published only now.

The study said the candidate vaccine also “elicited immune responses that exceeded levels in Covid-19 convalescent serum”, meaning it triggered a stronger response than that seen in patients who have recovered from the disease caused through natural infection.

The May trials were conducted on volunteers in two hospitals in Australia.

Novavax has already entered into an agreement with Pune-based Serum Institute of India for production of 100 million doses of the vaccine when it is ready. It is expected that 50 per cent of this would be meant for supply within India, and the remaining for other low and middle income countries.

Indian express

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