FDA finds Pfizer Covid vaccine is effective against coronavirus, so now what?

The health agency could give emergency authorisation to the vaccine as early as Thursday

The largest mass vaccination campaign could begin in the United States as early as this week following the latest news regarding Pfizer and BioNTech’s Covid-19 vaccine.

The Food and Drug Administration (FDA) released a 53-page report summarizing the data in the company’s candidate vaccine trial. The report found the data supported earlier findings that the vaccine was safe and 95 per cent effective against Covid-19.

So now what does that mean in the push to vaccinate the American public safe and efficiently?

Pfizer and BioNTech are still waiting to receive emergency authorisation from the FDA so they can officially start distributing its first supply of doses to states.

Read more: Where am I in line for the coronavirus jab?

This emergency authorisation could happen as early as Thursday after the FDA hosts an advisory committee meeting with independent experts. During the meeting, which is anticipated to last all day, the experts will discuss and vote on whether they would support Pfizer receiving that emergency use authorisation.

Ultimately the decision will be up to the FDA on if it gives Pfizer emergency authorisation, but the health agency decided to commission an independent panel in an effort to improve the public’s confidence in a coronavirus vaccine if it were to be rolled out to Americans.

States have until Friday to submit their requests for vaccine doses from Pfizer. New York, for example, was anticipated to receive 170,000 doses from the company in the first batch, Governor Andrew Cuomo said last week.

Before the end for the year, Pfizer has projected the United States will receive about half of the company’s global supply of coronavirus vaccines – about 25 million doses. This will vaccinate 12.5 million people as the vaccine requires two doses for full efficacy.

The company has promised 100 million doses in total to the country, and it said that will be available in the first couple months following receiving emergency authorisation.

Moderna, which is about one week behind Pfizer’s vaccine, has also applied for emergency authorisation through the FDA. It’s data will undergo an independent panel review process on 17 December, and government officials expect about 20 million doses will be available from the company after it receives emergency authorisation.

States will rely on guidance from the Centres for Disease Control and Prevention (CDC) and other health agencies to determine who should receive the vaccine first among the public.

Initial guidance recommends for healthcare professionals, 21 million Americans, and those living in long-term care facilities, 3 million Americans, should receive the vaccine first – which will take up the vast majority of initial doses available by the end of the year.

The CDC is expected to release final guidance in the near future about what population groups should follow healthcare professionals and those living in long-term care facilities. But it will likely be other first responders and the millions of Americans who suffer from health risks – such as asthma, heart disease, obesity, and diabetes – who will be next in line to receive the vaccine.

Health officials warned the vast majority of Americans might not have access to a coronavirus vaccine until late spring or summer 2021, but that timeline could be even further pushed back depending on how manufacturing and distributing the vaccines goes for each company.

Pfizer offered the federal government an additional 100 million doses over the summer for purchase, but the Trump administration reportedly turned those doses down, The New York Times reports.

The company has now warned it will not be able to provide more than 100 million doses until late June 3032 because of the promises it made to other countries around the world.

Americans were also advised to not let their guards down once public vaccinations begin.

Although both Pfizer and Moderna proved to be 95 per cent effective in preventing the patient from contracting Covid-19, there was little data to show if a vaccinated individual is unable to transmit the virus to those who are not yet vaccinated.

Coronavirus health guidelines like social distancing, wearing masks, and avoiding large crowds will likely continue for the months to come until the vast majority of the public can receive a vaccine.