Seeking approval for a 3rd dose, Pfizer and BioNTech take their COVID-19 booster data to the FDA

Since the spring, Pfizer has trumpeted the value of a booster shot after a two-dose course of its COVID-19 vaccine. Now, the company and development partner BioNTech are taking their data to the FDA.

In a phase 3 trial that enrolled 306 adults who received a booster dose five to eight months after a second COVID-19 shot, recipients' antibody levels increased more than threefold compared with after their second dose, Pfizer said Wednesday. Side effects after a third shot were no more prevalent among recipients than after the second dose, the partners said.

With the data, the partners have started an FDA rolling biologics license application for the booster dose in people 16 and older. They plan to complete the application this week and intend to submit booster applications to other regulatory agencies in the next few weeks.

For its part, the Biden administration is also enthusiastic about boosters. Last week, the administration revealed plans to roll out follow-up vaccines starting the week of Sept. 20.

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Pfizer's news came just hours after Johnson & Johnson reported that a booster shot of its single-dose COVID-19 vaccine produced a ninefold increase in spike-binding antibodies.

Also Wednesday, Moderna said it has completed its rolling submission for full approval of its COVID-19 vaccine in people aged 18 and older. As part of the application, Moderna has requested a priority review from the FDA.

Earlier this week, the Pfizer-BioNTech vaccine became the first COVID-19 vaccine to win a full FDA approval. Previously, the shot had been authorized on an emergency basis.

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Earlier this summer, to support its claim for the need for booster shots, Pfizer released data that showed the efficacy of its vaccine wanes after six months. Moderna has shown its vaccine to be more durable, but the company trails Pfizer in the regulatory submission process. Moderna’s application for use of its shot as a booster is expected to come next month.

Israel began administering booster shots a month ago. France, German and the U.K. plan to roll out boosters in September, defying a plea from the World Health Organization for a moratorium on boosters to increase the supply to needy countries.

Booster authorizations would further bolster revenues for Pfizer and Moderna. While Pfizer has estimated expected revenue from its vaccine to reach $33.5 billion this year, Bernstein analyst Ronny Gal has predicted the figure will reach $40 billion. Moderna has projected its vaccine will generate $19 billion in sales this year.