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US Closes in on Pfizer-BioNtech Covid Booster for All

09.11.2021 - Pfizer and BioNTech are expected to seek an Emergency Use Authorization (EUA) for their Covid-19-vaccine booster shot to be given to anyone 18 and older, an unnamed US official told journalists on Nov. 8, confirming a report by the newspaper Washington Post. The request could be made as early as this week, reports said.

This time around, the US Food and Drug Administration (FDA) is thought likely to give the green light, in contrast to several weeks ago, when its advisory panel and that of the Centers for Disease Control (CDC) turned thumbs down on the idea. In the final vote, boosters were   limited to those above age 65, the immunocompromised and those whose jobs put them at risk.

An altered FDA recommendation would essentially fulfill the Biden administration’s hope of offering a booster to all adults. In August, President Joe Biden announced plans for a Sept. 20 rollout, amid concerns about waning vaccine protection. In light of the health authorities’ decision, this subsequently had to be put on ice.

At press time, neither Pfizer nor BioNTech had commented on the health authority’s possible change of heart. Following the manufacturers’ earlier booster proposal, some voices had criticized Pfizer for attempting to further pad profits.

While in the US, the recent surge caused by the Delta variant appears to be subsiding, some health experts are concerned that infections and deaths could be plateauing at a high level. As November started, cases still exceeded 70,000 a day, and deaths totaled more than 1,000 daily. With cold weather in many states and the Thanksgiving holiday looming at the end of November, experts increasingly believe that more people could require a booster.

In September, the panels advising US health authorities said there was little evidence that young, healthy people needed an additional shot, especially when much of the world remained unvaccinated. Since then, however, additional data has pointed more strongly to a need for more than two shots per person.

Despite the lack of an official authorization for all, the Washington Post said more than 24 million fully vaccinated people in the US, about 12.4% of the total, have already received a booster dose.

EMA also advises same dose-boosters

The European Medicines Authority (EMA) has already recommended Covid vaccine boosters for all. Up to now, the rollout has been slow, however. In a number of countries the vaccination centers set up early last year have closed, and local physicians may not have sufficient capacity to ramp up inoculations.

As part of the booster discussion, the question of whether to mix doses from different manufacturers is commanding attention. While US heath authorities, including the CDC, recommend combining two different vaccines, citing studies that this boosts antibody production, some European countries are taking a different approach.

In Germany, the tendency is to offer a third dose from the same manufacturer to all of those previously receiving two doses of an mRNA-based vaccine. Johnson & Johnson’s single-dose shot could be boosted with an mRNA vaccine while recipients of Astra Zeneca’s product, including those who received a combination of AstraZeneca and Pfizer/BioNTech or Moderna, could also receive a third dose from one of the mRNA vaccines.

Author: Dede Williams, Freelance Journalist