Global COVID-19 death toll tops 1.1 millionNews

  • Global COVID-19 death toll tops 1.1 millionNews

Global COVID-19 death toll tops 1.1 millionNews

Besides, it expects to have data on the drug's safety by the third week of November, as per the report. It is still unknown who will be prioritized for COVID-19 vaccine and when a vaccine will be available. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients.

"People tend to think, 'Ah, on the first of January or the first of April I'm going to get the vaccine and then things will be back to normal, '" Swaminathan said.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November", Mr. Bourla wrote in an open letter.

"Each of the information in our USA program could be assessed not only by the FDA's scientists but also by an outside panel of independent experts at a publicly held assembly convened by the bureau".

"I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer's and our partner BioNTech's COVID-19 vaccine", Bourla said. On the one hand, he pointed out that "it induces a complete immune response, so much humoral (neutralizing antibodies) such as cellular (mediated by T lymphocytes) ".

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials.

In August, North Dakota was selected by the Centers for Disease Control and Prevention (CDC) as one of four states to be part of a pilot project to plan for the distribution of a future COVID-19 vaccine.

Two vaccinations by the end of the year?

Another leading USA contender, Moderna Inc., previously announced the earliest it could seek authorization of its own vaccine would be November 25.

Both Pfizer and Moderna began phase three of their clinical trials in late July and both have started dose production, to be in a position to distribute tens of millions in the United States by the end of the year.

As per the US Food and Drug Administration (FDA) norms, to get authorisation for emergency use of experimental coronavirus vaccine, companies have to submit at least two months of safety data.

Pfizer CEO Albert Bourla has long said it's possible testing might reveal by the end of October if his company's vaccine actually protects against the coronavirus. Three were in Moderna's trial, while the other two were in Pfizer's.

In any case, they are unlikely to be a good substitute for wearing masks, social distancing, and other recommended behaviors to curb transmission, as how effective they will be is unknown at this time.