FDA Authorizes COVID-19 Boosters That Will Target Omicron

FDA Authorizes COVID-19 Boosters That Will Target Omicron

  • The new COVID-19 booster campaign will include shots that also target the Omicron virus variants.
  • The Food and Drug Administration authorized on Aug. 31 updated boosters for Moderna and Pfizer-BioNTech.
  • The director of the Centers for Disease Control and Prevention will need to sign off on the updated boosters before they can be rolled out to the public.

With the country’s third “COVID fall” approaching, the United States is expected to start ramping up its autumn COVID-19 booster campaign — with something new in store for this year.

On Aug. 31, the Food and Drug Administration authorized the use of bivalent boosters that include both the original vaccine formula and a component that targets the currently circulating Omicron BA.4 and BA.5 subvariants of the coronavirus.

This is the first updated COVID-19 vaccine to be authorized in the United States.

Next, an advisory committee to the Centers for Disease Control and Prevention (CDC) will meet Sept. 1 to make recommendations on which groups should receive these updated boosters.

The CDC director will also need to sign off on the boosters before they can be rolled out to the public. Once this happens, the updated boosters could be available to the public in early to mid-September.

The Omicron variant has overcome much of the protection against infection offered by two doses of the mRNA vaccines (such as Moderna and Pfizer-BioNTech).

A first booster restores some of that protection, but this wanes considerably within about three months after vaccination.

In spite of that, Dr. David Cutler, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, Calif., told Healthline that the current vaccines continue to offer strong protection against severe illness and death.

This is especially true of the boosters.

In June 2022, unvaccinated people were five times more likely to die of COVID-19, compared to people vaccinated with at least a primary series (for most, two doses of the mRNA vaccines), according to the CDC.

Among people 50 years and older, unvaccinated people were 14 times more likely to die of COVID-19 than those who had received the primary series and at least two booster doses, agency data showed.

The current COVID-19 vaccines and boosters are based on the original strain of the virus. As CDC data shows, these still offer strong protection against severe disease caused by Omicron.

However, in order to better target the variants likely to be circulating in the fall, the Food and Drug Administration (FDA) asked vaccine makers in June 2022 to update their boosters to include a component that targets the currently circulating Omicron BA.4 and BA.5 subvariants.

“We think the Omicron-specific boosters will improve immunity against the existing Omicron variants. This may be particularly helpful during the anticipated winter surge,” Dr. Jimmy Johannes, a pulmonologist and critical care medicine specialist at MemorialCare Long Beach Medical Center in California, told Healthline.

However, not all scientists agree that Omicron-specific boosters will provide greater protection than the current ones.

Cutler thinks the strongest benefit of Omicron-specific boosters will be for people who are unvaccinated or have not received the full primary series and any booster(s) for which they are eligible.

Data presented at an FDA vaccine advisory committee meeting in June 2022 suggests that vaccination with a variant-specific booster — such as one targeting Omicron — might lead to a “broadened antibody response” against the coronavirus.

In addition, data from Moderna shows the potential for this kind of broader immune response. The company’s bivalent Omicron BA.1 booster produced a higher level of neutralizing antibodies against BA.4 and BA.5 than the original booster, according to preliminary data.

On August 15, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency approved Moderna’s bivalent Omicron BA.1 booster for use in adults.

One problem with choosing months in advance which booster to use is it’s impossible to know for certain which variants will be circulating by then.

But in this case, the updated boosters should fit the situation on the ground. The Omicron BA.5 subvariant is still widely circulating in the United States — with a smaller spread of BA.4 — and should still be spreading by the time the updated boosters are rolled out.

Some experts also say there’s a good chance that any variants that emerge in the near future will be descendants of one of the currently circulating Omicron variants.

The Moderna and Pfizer-BioNTech boosters based on the original strain of the coronavirus are currently available for anyone who is eligible now for a first or second booster.

The bivalent boosters from those companies are expected to be available in early to mid-September, Dr. Ashish Jha, White House COVID-19 response team coordinator, said in a virtual discussion with the U.S. Chamber of Commerce Foundation on August 16.

The fourth vaccine in the country, Novavax’s protein-based vaccine, was authorized by the FDA on July 13, 2022 for use as a two-dose primary series. This vaccine is based on the original strain of the coronavirus.

The company announced the next month that it had applied for FDA authorization of this vaccine as a booster. It is also testing an Omicron-specific vaccine and a bivalent vaccine that targets Omicron and the original strain, the company said in a release.

Everyone currently eligible for a COVID-19 booster will still be eligible for these boosters, including:

  • First booster: everyone ages 5 years and older who has completed their primary series
  • Second booster: adults ages 50 years and older; and some people ages 12 years and older who are moderately or severely immunocompromised

Johannes said anyone at risk of severe COVID-19, or complications of a coronavirus infection, should consider getting boosted when the bivalent vaccine is available.

This includes older adults, as well as those with chronic medical conditions such as heart disease, liver or kidney disease, a chronic respiratory condition, cancer, an immune compromising condition, high blood pressure or diabetes.

The Biden administration is also expected to open up second boosters this fall to adults under age 50 when the bivalent vaccines are available. This expansion of eligibility was put on hold when vaccine makers said they could deliver the bivalent vaccines in early fall.

When the bivalent boosters are available, the following people will be eligible to receive them:

  • Pfizer-BioNTech bivalent booster: People 12 years of age and older, at least 2 months after completing the primary series or receiving a booster dose with the original vaccine
  • Moderna bivalent booster: People 18 years of age and older, at least 2 months after completing the primary series or receiving a booster dose with the original vaccine

The original vaccines will continue be used as the primary series for people 6 months of age and older, the FDA said in a statement when it authorized the updated vaccines. In addition, the original Pfizer-BioNTech vaccine will continue to be used as a booster dose for people 5 through 11 years of age.

It should be noted that pregnant women are still eligible for boosters, as well as the primary series.

“The [COVID-19 mRNA] vaccines have now been given to tens of millions of pregnant women. They are extremely safe,” said Jha during the online Chamber of Commerce call. “We have seen little to no side effects [in pregnant women], the same side effects that most of us get — the sore arm, sometimes 24 hours of feeling fatigued or a little bit run down.”

Bolstering the safety profile of these vaccines, a large study from Canada published August 17, 2022, in The BMJ found that women who received a COVID-19 vaccine during pregnancy did not have a higher risk of having a preterm birth, a baby who was small for their gestational age at birth, or a stillbirth.

Vaccines are likely to mainly be available at doctors’ offices and pharmacies. Some mass vaccinations may also happen in certain locations.

To find a vaccination site near you, check out the federal Vaccines.gov or your state’s COVID-19 vaccine website.

It’s difficult to know what the coronavirus will do in the fall — will there be a large spike early in September or will a new variant emerge?

As a result, the CDC recommends getting boosted as soon as you are eligible, with whichever booster is available. This is especially important for adults 50 years and older or those with compromised immune systems.

It can take one to two weeks after receiving a booster for your immune system to be fully primed. So if you are eligible now and get boosted, you will be better protected should cases surge as we head into the fall and winter.

You can always get the bivalent vaccine when it is available. Jha said you will want to space out those two boosters “at least a little bit, probably 4 to 8 weeks.”

The CDC may also weigh in on the timing between boosters when it reviews the data on the Omicron-specific boosters.

Jha said if you are planning on getting the seasonal flu shot this fall, you can definitely get this alongside a COVID-19 booster.

The CDC recommends that people get vaccinated against the flu by the end of October to ensure they have strong immune protection at the peak of the flu season, which generally happens in February.

Scientists don’t know yet if the coronavirus that causes COVID-19 will follow a similar seasonal pattern, but cases have tended to increase in colder parts of the country as people head indoors for the fall and winter.

At this point, it does not appear that the bivalent vaccine will be used for people who are unvaccinated.

Although the FDA asked vaccine makers to update their boosters to include an Omicron-specific component, it did not advise them to update the vaccine for the primary series.

In addition, the agency announced on Aug. 31 that the original COVID-19 vaccines will continue to be used for the primary series for people 6 months of age and older.

https://www.healthline.com/health-news/fda-authorizes-covid-boosters-targeting-omicron-what-to-know