FDA won’t require lengthy clinical trials for COVID-19 boosters

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Future COVID-19 vaccine boosters will not have to go through the traditional lengthy clinical trial process to be approved for emergency use in the US. report to Reuters. An agency spokesman, speaking ahead of the publication today, said the U.S. Food and Drug Administration (FDA) will instead rely on data from vaccine trials developed earlier in the pandemic to target specific variants of the virus, as well as manufacturing data when considering whether boosters should be cleared for administration. Preclinical animal studies and safety data could also be used, the official said.

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Like an edge notes in its news coverage, a variant of COVID-19 known as omicron has branched into several sub-strains since its introduction late last year, including BA.4 and BA.5. The FDA is urging vaccine manufacturers to target BA.4 and BA.5, the most common lines in the US.

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Boosters targeting BA.1 are still effective against BA.4 and BA.5, according to early data from Moderna and Pfizer/BioNTech. But the immune response they generate against newer lines is weaker than that against BA.1. Pfizer is also developing a booster for BA.4 and BA.5 which is in the early stages of testing.

The new boosters are expected to be available in the fall. However, it remains unclear how many suitable people will look for them. In the US, more than 78% of the population has received at least one dose of the COVID-19 vaccine. But it turned out that delivering subsequent doses to adults with one study showing that up to 50% of people failed to get a booster – or shots – within a year of the first one.

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With omicron almost 60% in US were infected during the pandemic, according to statistics released in April by the U.S. Centers for Disease Control and Prevention. Currently, the number of hospitalizations due to COVID-19 in the country averages between 1,400 and 10,500 people, and the number of deaths ranges from 1,300 to 4,600 people.

In an encouraging development this week, COVID-19 vaccines have been authorized for children from 6 months.


Credit: techcrunch.com /

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