FDA Grants BioNTech Full Approval for Covid Vaccine

24.08.2021 - First to receive US approval under an Emergency Use Authorization (EUA) in late 2020, the BioNTech/Pfizer Covid-19 vaccine on Aug. 23 became the first to be fully approved by the US Food and Drug Administration (FDA) for marketing and use in the country.

US approval for the vaccine, officially granted to Germany-registered BioNTech, which owns the mRNA technology, applies to people 16 years of age and older. For adolescents aged 12 to 16, the EUA issued earlier this year will continue to be the basis. The German-American partnership has not yet applied for full approval for this shot.

While US president Joe Biden had initially signaled that full authorization could take place for “sometime in September,” repeatedly leaks said the FDA was aiming for Sept. 6, the US Labor Day holiday, as a milestone marker. The intent additionally was to prop up sagging interest in getting the shot amid a flood of disinformation and a rapidly rising number of infections nationwide.

The decision to grant full authorization for the vaccine now known as Comirnaty came after a priority review by the FDA’s panel of independent experts and according to reports was one of the quickest approvals on record. Whether the official stamp of approval will suffice to convince vaccine skeptics who reject vaccination on grounds that the technology has not been studied long enough remains to be seen.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic. While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting commissioner Janet Woodcock said in a statement.

Biden Urges all Americans to Line up for a Shot

Immediately after the agency’s announcement, Biden urged all Americans to line up for a shot “today,” saying, “there is no time to lose.” In the wake of the news, the US military said it would accelerate its timeline for requiring all troops to get vaccinated, and New York mayor Bill de Blasio said the city would mandate vaccinations – with no opt-outs – throughout its school system, starting in September. Other jurisdictions were expected to follow suit, with the exception of states whose governors have rejected even mask-wearing.

To support its decision-making process, the FDA panel looked at updated results from the companies’ original clinical trials submitted for the EUA and included a longer follow-up in a larger clinical trial population. The health watchdog said it analyzed effectiveness data from some 20,000 vaccine and 20,000 placebo recipients aged 16 and older who did not have evidence of infection with the virus within a week of receiving the second dose. Safety was evaluated in approximately the same cohort.

The updated results showed Comirnaty to be 91% effective in preventing Covid-19 disease, down slightly from 95% in the original trials. The FDA apparently did not address the question of how effective it was in preventing infection. The agency said more than half of the trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients were followed for at least six months.

US biotech Moderna, manufacturer of the only other mRNA-based Covid vaccine, has filed with the FDA for full authorization of its shot, but has not completed the paperwork, reports said. Johnson & Johnson said it plans to apply sometime this year. Across the Atlantic, the European Medicines Agency (EMA) has already granted conditional marketing approval to all three US-administered Covid vaccines, in addition to that of AstraZeneca.

EMA Could Grant Standard Marketing Authorization

This European authorization is considered to be a step beyond the EUA, although it does not qualify as full approval. In response to the US move, the European Medicines Authority said its conditional green light could be switched to a standard marketing authorization if the manufacturers apply for it and provide the required paperwork.

Pfizer and BioNTech have said they plan to deliver more than 2 billion Comirnaty doses worldwide during 2021, while manufacturing 3 billion altogether this year and 4 billion next year. For full year 2021, the New York-based US drugmaker said it expects its own Covid vaccine-related sales to total $33.5 billion, while BioNTech has forecast related sales of $18.7 billion.

Thanks to its Covid vaccine, US trade journal Fierce Pharma said BioNTech could advance into the ranks of the world's top 20 drugmakers by sales this year, joining Teva, Biogen and Novo Nordisk near the bottom. Pfizer ranked 8th in 2020, but is expected to move higher.

In a conference call with analysts, US press reports quoted Sean Marett, chief business and commercial officer at BioNTech, as saying that in future orders both Europe and the US could take advantage of an updated vaccine or new formulation able to deal with virus variants like Delta, “if approved and available.”

As first reported by UK business newspaper Financial Times, both Pfizer/BioNTech and Moderna have raised prices for their Covid vaccines in their new European purchase agreements. The duo’s shot will cost €19.50 ($23.15) per dose, while Moderna will charge $25.50 per dose. The EU’s May contract is said to require that all doses sold in the EU be made in the 27-member bloc.