Updated COVID-19 Vaccines Are Coming to the US, Should You Get One?

Updated COVID-19 Vaccines Are Coming to the US, Should You Get One?

By Ahmed Aboulenein and Julie Steenhuysen

WASHINGTON/CHICAGO (Reuters) – The United States plans to release an updated COVID-19 booster vaccine to include Omicron subvariants of the coronavirus. Regulators are reviewing the shots and may give the go-ahead as early as next week.

Here’s what you need to know:

WILL WE RECEIVE NEW VACCINES?

Pfizer Inc with partner BioNTech SE and Moderna Inc this week completed applications to the U.S. Food and Drug Administration for reformulated COVID-19 vaccine boosters to target versions of the Omicron variant of the virus.

These so-called bivalent vaccines include the currently dominant BA.4/BA.5 Omicron subvariants and the original version of the virus.

Pfizer’s vaccine would be for people 12 and older, while Moderna’s would be for people 18 and older.

The FDA will likely decide on the vaccine soon. The US Centers for Disease Control and Prevention (CDC) has scheduled a two-day meeting of its expert advisors starting Sept. 1, a step that normally follows FDA clearance.

The United States has ordered 175 million doses from Pfizer/BioNTech and Moderna, which should be ready to ship in September.

WHO SHOULD GET AN UPDATED BOOSTER?

Government health officials say boosters are needed because immunity wanes over time and vaccines help prevent serious illness and death.

Several experts said they do not expect the updated vaccines to be a game-changer and urged public health officials not to exaggerate their benefits.

“What the administration is asking us is that we accept that this bivalent vaccine is significantly better than the current ancestral strain vaccine. It would be nice if there were data to support this,” said Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel.

“Right now what they’re asking is that you trust them and trust them with your mouse data, and I think that’s asking too much.”

Currently, a fourth dose, or second booster, is primarily restricted to people over 50 and people who are immunocompromised or at high risk. The government plans to open up Omicron boosters to people age 12 and older, according to a CDC document https://www.cdc.gov/vaccines/covid-19/downloads/CDC-Fall-Vaccination-Operational-Planning- Guide.pdf .

People in these same risk groups are more likely to benefit from the new boosters, said Dr. Celine Gounder, infectious disease epidemiologist and editor-at-large of Kaiser Health News.

“If you don’t fall into one of those categories, it’s really a question of how much additional benefit you get,” she said.

Gounder recommends that those who have recently received a booster or COVID-19 wait at least three months to give the immune system the best chance of mounting a robust response.

John Moore, professor of microbiology and immunology at Weill Cornell Medical College in New York, said the most important thrust is the first. “Anyone who has not received this booster should do so as soon as possible, regardless of the vaccine’s composition,” he said.

WHAT DO THE DATA SAY?

Pfizer has presented data on its BA.4/BA.5 booster from laboratory and animal studies. The company says it generated a strong neutralizing antibody response against these and other Omicron variants, as well as the original strain of the virus.

The company provided regulators with data from a human trial testing the immune response to an injection that combined the original vaccine with the BA.1 Omicron variant. He plans this month to begin a similar trial of the BA.4/BA.5 booster in people aged 12 and over.

Moderna’s FDA application includes data from animal studies of the BA.4/BA.5 booster. An intermediate-stage trial of the vaccine in people is underway.

(Reporting by Ahmed Aboulenein in Washington, Julie Steenhuysen in Chicago and Mrinalika Roy in Bengaluru)

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