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Report: FDA to Unveil Booster Dose Strategy by Early September

The plan comes in the wake of several other countries planning to provide extra doses of covid-19 vaccines to immunocompromised and older people.

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Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic targeting minority community members at St. Patrick’s Catholic Church on April 9, 2021 in Los Angeles, California.
Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic targeting minority community members at St. Patrick’s Catholic Church on April 9, 2021 in Los Angeles, California.
Photo: Mario Tama (Getty Images)

U.S. health officials are reportedly getting close to issuing a verdict on the immediate need for booster vaccines against covid-19. This week, the Wall Street Journal reported that the Food and Drug Administration is set to have a plan for booster shots ready by early next month, one that would dictate which populations should receive them and when. Other highly vaccinated countries are preparing to or have already started to rollout their own booster doses, even as some authorities are pleading for vaccine equity throughout the world first.

On Thursday afternoon, the Wall Street Journal, citing anonymous sources, reported that FDA will unveil its booster dose plan by early September. The Biden administration has reportedly been pushing for a strategy to emerge soon, given concerns that older and immunocompromised people may need a booster more urgently than others, due to waning immunity over time and the emergence of the more transmissible and possibly more virulent Delta variant.


Some data from Israel has suggested that older vaccinated people may experience waning immunity past the sixth-month mark. Other studies have found that certain populations of immunocompromised people don’t respond as robustly to inoculation as the general public and that a third dose can meaningfully improve their immune response to the virus. In recent weeks, vaccine makers such as Pfizer and Moderna have also been calling for boosters to be deployed in time for the fall and winter.

At the same time, not all scientists agree that booster doses are a necessity at this time, particularly for the average person. Moderna and Pfizer’s own clinical trial data has suggested that vaccine-provided immunity remains robust in most people at least six months out. Some experts have also questioned whether Israel’s data is a real sign of waning immunity. And despite concerns about variants like Delta, most of the evidence continues to indicate that vaccines provide roughly the same level of protection against serious illness from Delta as they did against past strains, though perhaps not as much protection from infection altogether.


Another concern many public health experts have voiced is about using vaccines for booster shots when so little of the world is vaccinated at all. Yesterday, the World Health Organization called for a moratorium on booster shots until at least late September or when 10% of every country’s population is vaccinated. Just today, the European Union’s drug regulators stated that there wasn’t enough evidence to support the use of booster doses at this moment. Currently, only 29% of the world population is partially vaccinated, while 15% is fully vaccinated, with poorer countries having far lower vaccination rates than wealthier countries like the U.S.

Despite the wishes of the WHO or EU, it seems likely that booster shots will be on the way for some people. The EU’s assessment came after several EU countries and the UK announced they would start boosting older residents by September. In America, hospitals and vaccine clinics are already having to deal with people going rogue trying to get booster doses, sometimes by concealing the fact that they’ve already had a vaccine.

Relatedly, the city of San Francisco announced this month that residents who took the Johnson & Johnson single-dose shot could freely get a mRNA booster shot. Like booster shots in general, this may improve someone’s immune response to the virus, but it’s not clear that it’s really needed to prevent the most serious outcomes. On Friday morning, researchers from South Africa unveiled the results of a highly anticipated study of health care workers who received the Johnson & Johnson one-dose vaccine. They found that the vaccine provided 91% to 96% protection against death from the Delta variant, and around 71% protection against hospitalization—levels comparable to its performance against the Beta variant, the previously dominating strain in the country. The results, while not yet peer-reviewed, do indicate that the vaccine remains effective against Delta.

Many vaccinated people will certainly have no issue getting a booster dose if advised to by health authorities. But the matter of proper timing is still a complicated and increasingly political issue.