FDA to unveil booster dose strategy by early September



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Vials containing doses of the Pfizer COVID-19 vaccine are examined at a clinic targeting members of the minority community at St. Patrick's Catholic Church on April 9, 2021 in Los Angeles, California.

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

US health officials are said to be on the verge of rendering 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 should have a plan for booster shots ready early next month, which would dictate which populations should receive them and when. Other heavily vaccinated countries are preparing or have already started to deploy their own booster doses, even as some authorities advocate for equity in vaccines worldwide first.

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

Some data from Israel have suggested that older vaccinated people may experience decreased immunity after the sixth month. Other studies have shown that some populations of immunocompromised people do not respond as vigorously to inoculation as the general public and that a third dose may significantly improve their immune response to the virus. In recent weeks, manufacturers of vaccines such as Pfizer and Modern also requested that boosters be deployed in time for fall and winter.

At the same time, not all scientists agree that booster doses are a necessity right now, especially for the average person. Moderna and Pfizer clinical trial data have suggested that the immunity provided by the vaccine remains robust in most people for at least six months later. Some experts also interrogates whether Israel’s data is a real sign of declining immunity. And despite concerns about variants like Delta, most of the evidence continues to point to the vaccines providing roughly the same level of protection against serious Delta illnesses as against earlier strains, although perhaps not so much protection of infection completely.

Another concern voiced by many public health experts is the use of booster vaccines when so few people in the world are vaccinated. Yesterday, the World Health Organization called for a moratorium on booster injections until at least the end of September or when 10% of the population of each country is vaccinated. Even today, the European Union’s drug regulators declared that there was insufficient evidence to support the use of booster doses at this time. Currently, only 29% of the world’s population is partially vaccinated, while 15% are fully vaccinated, with poorer countries having much lower vaccination rates than wealthier countries like the United States

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

At the same time, the city of San Francisco announcement This month, that residents who took the Johnson & Johnson single-dose vaccine were able to freely receive an mRNA booster. THELike booster shots in general, it can improve a person’s immune response to the virus, but it is not clear that it is really necessary to avoid the most serious consequences. On Friday morning, researchers in South Africa unveiled the results of a long-awaited study of healthcare workers who received the Johnson & Single dose Johnson vaccine. They find that the vaccine provided 91% to 96% protection against Delta variant death, and approximately 71% protection against hospitalization– levels comparable to its performance against the Beta variant, the previously dominant strain in the country. The results, although they have not yet been peer reviewed, indicate that the vaccine remains effective against Delta.

Many people who have been vaccinated will certainly have no problem getting a booster dose if advised by health authorities. But the question of good timing remains a complicated and increasingly political question.



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