FDA Gives EUA to Pfizer-BioNTech’s Covid Vaccine

14.12.2020 - The US Food and Drug Administration on Dec. 11 awarded an emergency use authorization (EUA) for the Pfizer-BioNTech mRNA-based Covid-19 vaccine. The green light followed a recommendation hours earlier by the US health regulator’s advisory panel, which voted 17 to 4 in favor – with one abstention – to offer the shot to people 16 years of age and older.

With their vote, the advisers were asked to confirm that they thought the benefits of the vaccine outweighed any risks. Two of those voting against recommendation told the US press they would have voted differently if the age bracket had been 18 and up.

The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) also recommended the use of the Pfizer-BioNTech vaccine, saying that inoculation should begin as soon as supplies are distributed.

The FDA had initially planned to announce its decision – most likely in favor of the EUA – on Dec. 12 or Dec. 13 to allow it enough time to review the panel’s recommendations.

According to US press reports, the decision to press ahead was hastened by a phone call from Mark Meadows, chief-of-staff to president Donald Trump, threatening to fire FDA commissioner Stephen Hahn if he did not announce approval immediately.

Hahn, while acknowledging the call, denied the dismissal threat. President-elect Joe Biden is expected to choose a new FDA commissioner when he takes office, anyway, as is generally the case for a new administration.

Some US presidents leave the commissioner in place if the officeholder is highly regarded in the medical world, but Hahn is seen as tainted by his repeated issuing of EUAs for questionable products, in deference to Trump.

While stressing that it was extremely unlikely that the FDA would not grant the authorization, the interference from the White House made it appear that the decision was politically motivated, thus undermining the acceptance of the vaccine, many commentators from the US health sector noted.

The US is the fifth country to grant an emergency authorization for Pfizer-BioNTech’s mRNA –based vaccine. The UK gave its nod a week earlier, followed by Bahrain, Saudi Arabia and Canada. Mexico issued an EUA on Dec. 11, shortly after the US. The EU’s European Medicines Agency (EMA) is expected to follow suit on Dec. 29.

The go-head for Pfizer and BioNTech comes just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists and kicked off the global search for a vaccine, making this the fastest-ever development of an immunization project.

The development of a new vaccine by two virtually unknown companies and via a genetic route also represents a sea change for the pharmaceutical industry. Neither BioNTech nor Moderna has ever made a commercial product but now both are stock market powerhouses. BioNTech is valued at $30 billion, Moderna at $60 billion.

The FDA’s advisory committee will meet again on Dec. 17 to review data from the Covid vaccine being developed by US biotech Moderna. Like the American-German vaccine, this is also based on mRNA. The two vaccines are the first ever to be based on this genetic concept and both were shown in clinical trials to be around 95% effective.

As of now, the FDA is recommending that the vaccine not be given to anyone with a known history of severe allergic reactions (anaphylaxis) to any of the components. These reactions were reported in two British healthcare workers who were given the first doses last week.

The first shipment of 2.9 million doses of the Pfizer-BioNTech vaccine was expedited on the weekend from Pfizer’s warehouses in the US states of Michigan and Wisconsin to 600 recipients, for the most part healthcare systems overseen by the CDC and the US Department of Health and Human Services (HHS).

An additional 2.9 million doses for the second vaccination, to be held 21 days after the first, are due to be sent in due time. Altogether, US authorities project that 40 million doses of the two mRNA vaccines, including Moderna’s, will be delivered by the end of 2020.

The formulation of the Pfizer-BioNTech virus requires cooling at temperatures of minus 70 degrees Celsius. Pfizer has commissioned special coolers packed with 50 lbs of dry ice.

The US has another 300 million Covid-19 doses under contract from Pfizer-BioNtech and Moderna. Deployment after that will depend on how fast production can be ramped up and new purchase agreements negotiated.

Another factor is the speed at which other vaccines already under contract but still in development are approved. Several developers have recently suffered setbacks in clinical trials.

Author: Dede Williams, Freelance Journalist