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FDA Speeds up Full Approval Process for Comirnaty

11.08.2021 - Pfizer and BioNTech applied to the US Food and Drug Administration (FDA) in May for full authorization of their Covid-19 vaccine Comirnaty, and in the interest of encouraging more Americans to get vaccinated the health agency is now conducting a priority review to speed the approval process.

First to win emergency use authorization, in December 2020, the Pfizer/BioNTech partnership is also the first vaccine maker to complete an application for full approval. Moderna, the other mRNA vaccine maker, launched the application process in June, but has not completed its data submission. Johnson & Johnson has not yet applied at all, but said it plans to do so later this year.

The US health watchdog said this week that its review of the Pfizer/BioNTech biologics license application (BLA) is moving forward as rapidly as possible, “in keeping with the high-quality complete assessment that the public expects from the FDA.” The agency has said repeatedly that it wants to make sure the efficacy and safety profile is watertight and beyond reproach.

Citing multiple sources, the New York Times suggested that the green light for the American-German duo should come by Labor Day, the first Monday in September. US president Joe Biden, who has pushed for the speed-up, said earlier he expected the go-ahead to come by September or October.

To accelerate the review, senior officials at the health agency told pharma journal STAT that its center charged with reviewing vaccines is planning to deprioritize some of its existing work such as postponing meetings with drug sponsors and plant inspections.

With the Delta variant of the coronavirus now sending US infection numbers sharply upward, there is considerable pressure on the Biden administration to counter the impression created by the anti-vaccination camp that the vaccines are experimental and insufficiently tested. “We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated,” the agency said in a statement.

In a poll conducted by the Kaiser Family Foundation in June, three out of ten unvaccinated adults reportedly said they would be more likely to get vaccinated if one of the shots currently authorized for emergency use were to receive full approval. Full approval would also give businesses, the government and organizations such as colleges and the military the authority to require vaccinations.

Despite the urgency, the health watchdog wants to avoid any accusations that it is acting with undue haste. In a guest essay published in The Times last month, the agency’s top vaccine regulator, Peter Marks, wrote that this “would undermine the FDA’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

The regulators’ task, Marks said, is to examine real-world data on how the vaccine has performed since it was authorized for emergency use. This includes verifying the manufacturers’ data on efficacy and immune responses, reviewing how this might decline over time, examining new infections in participants in continuing clinical trials and reviewing adverse reactions to vaccinations and inspecting manufacturing plants.

Pfizer and BioNTech’s preliminary figures for Comirnaty show that, at 91.3% in people who have received two doses, efficacy against symptomatic Covid-19 is still high for as much as six months – slightly lower than in the original trials – but wanes as time progresses. The companies have launched a study to evaluate the effect of a booster shot that would offer more protection against circulating and potential new variants, saying it would offer a “flexible solution for rapidly adapting the vaccine.”

Author: Dede Williams, Freelance Journalist

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