Apollo Hospitals gears up to administer 1 million covid-19 vaccine

Henrietta Brewer
October 17, 2020

The timeline now allows for a possible USA authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Pfizer Inc. can not request emergency authorization of its COVID-19 vaccine before the third week of November - and that's if everything goes well, the company's CEO announced Friday.

For months, Pfizer CEO Albert Bourla had maintained that the company would know this month whether its BioNTech-shared COVID-19 vaccine works.

Pfizer won't apply for FDA emergency use authorization before the third week of November, Bourla wrote in an open letter on Friday. Hundreds of thousands of people have been given experimental vaccines in late-stage trials as part of an emergency inoculation programme launched in July. This would allow the companies to file for an emergency use authorization. Trials for a vaccine produced by AstraZeneca remain frozen by the Food and Drug Administration after a neurological issue was discovered in a trial participant in the UK.

The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months.

Bourla estimated that Pfizer's 44,000-person study would reach that milestone in the third week of November. It needs to be stored at sub-zero temperatures, creating logistical headaches in how to effectively ship and store doses so that millions of Americans can be inoculated.

That's a clear shift from Bourla's previous comments, which constantly featured "October" as the key word-at a time when President Donald Trump was touting a vaccine before the November 3 election, and mentioning Pfizer by name.

Stating that there are "ups and downs in any vaccine clinical trial", Dr Soumya Swaminathan, chief scientist at the World Health Organization, also said a vaccine against Covid-19 should be ready by the second quarter of next year.

Dr. William Schaffner, professor of preventative medicine at Vanderbilt University, told TPM in an interview last month that the vaccine would not singlehandedly end the pandemic.

"There's this unstated hope that the day the vaccine is approved, we can stop all the social distancing and mask wearing".

The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production.

"India is heading fast towards vaccine development, as two manufacturers are already in phase-3 trial and one in the phase-2 trial".

Other reports by iNewsToday