On a day when Pfizer and BioNTech revealed that they were submitting COVID-19 booster-shot data to the FDA, the government looks to be a step ahead in the process.
The Biden administration has decided to recommend booster shots for most Americans, multiple news outlets report. The endorsement could come as early as this week, said The New York Times, citing administration officials, who added that boosters could be made available as early as mid-September.
CDC vaccine advisors will meet on Aug. 24 for “discussions on additional doses of COVID-19 vaccine, including booster doses,” the agency revealed in a filing.
The new recommendation would allow for people to receive a third vaccine of the Pfizer or Moderna shots eight months after receiving their second dose. The urgency for the sanction comes as cases of the delta variant are on the rise in the U.S. and because severe breakthrough cases among vaccinated people are rare.
Pfizer has released data showing 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 plans to ask regulators for a booster authorization next month.
Once authorized for the general population, boosters would be apportioned based on priority need, The New York Times reports. They would first be provided in nursing homes and to healthcare workers and then to the elderly. Last Thursday, the FDA signed off on booster doses for people who are immunocompromised, but that covers only about 3% of the population.
The phase 1 data submitted by Pfizer and BioNTech to the FDA on Tuesday showed that a third dose created a significantly higher antibody count compared to levels observed after the two-dose series. The booster provided for added protection against the beta and delta variants, as well.
The companies said they will send the data to European regulators in the coming weeks. Phase 3 data on boosters will soon be available, the partners said.
Meanwhile, the FDA is also pressing to issue a full approval for Pfizer and BioNTech's vaccine by Labor Day, according to reports.
Israel began administering booster shots to fully vaccinated elderly people three weeks ago. Those 50 and older are eligible this week. France, Germany and the U.K. will roll out boosters in September. The countries are ignoring a plea from the World Health Organization for a moratorium on boosters to increase supplies to needy countries.
Government authorization for COVID-19 boosters would further bolster revenues for Pfizer and Moderna. In reporting second quarter earnings, Pfizer said it expects to reach $33.5 billion in COVID-19 vaccine sales this year. Moderna has projected that it will rake in $19 billion in vaccine revenues.
Ahead of the booster news, Bernstein analyst Ronny Gal on Friday predicted Pfizer’s COVID-19 vaccine sales will reach $40 billion this year. Gal also sees Pfizer and Moderna’s already dominant share of the market growing even further beyond 2021.
“We feel increasingly confident that mRNA vaccines have ‘won’ the market,” he wrote. “We give all volume in 2023 and beyond to Pfizer and Moderna in developed markets.”