US authorities approve updated booster shots targeting omicron

Deutsche Welle

Posted at Sep 01 2022 10:44 AM

The US Food and Drug Administration (FDA) has authorized a revamped version of the COVID-19 booster shot from the two big pharmaceutical companies providing the vaccine in the US, Moderna and BioNTech-Pfizer.

The reworked vaccines will target the BA.4/BA.5 omicron subvariants specifically, which are dominant in the US at present. Both pharmaceutical companies' jabs are part of efforts in the US to vaccinate the population as the country heads into fall.

The retooled shots could start being administered within days. They are designed for those who received the initial coronavirus vaccinations.

The US approval follows similar authorization being granted in the UK.

Moderna's single dose is authorized for adults 18 and over, whereas Pfizer's two dose regimen is approved for people aged 12 and above.

The US has purchased more than 170 million doses of the boosters from the two companies with the hopes of preventing another significant wave of infections as the seasons change and people are forced indoors.

Pfizer said it could ship 15 million doses by week's end. The company also said it would request approval for the dose from the FDA for 5 to 11-year-olds come October.

In the US, half of those who received the first two doses of the COVID vaccine received the first recommended booster dose. One-third of those 50 and older who received the recommendation to get the second booster shot did so.

What has been the regulatory process to date?

In June, the FDA asked the manufacturers to adjust the jabs to better respond to the two subvariants surging internationally. In the US, the BA.5 subvariant of the coronavirus, considered the most contagious yet, is responsible for nearly 90% of infections.

Remaining regulatory hurdles include the US Centers for Disease Control and Prevention (CDC) making recommendations on the matter. The agency is expected to convene an independent panel of experts on Thursday to discuss the updated shots, before CDC director Rochelle Walensky makes a final determination.

As viruses change, it is not unusual for existing vaccines to be modified. For instance, the flu vaccine is updated annually.

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