FDA Approves COVID-19 Boosters Targeting Omicron

  • The new COVID-19 booster campaign will feature footage also targeting the Omicron virus variants.
  • The Food and Drug Administration approved updated boosters for Moderna and Pfizer-BioNTech on August 31st.
  • The director of the Centers for Disease Control and Prevention must approve the updated boosters before they can be released to the public.

As the country’s third “COVID case” approaches, the United States is expected to begin ramping up its fall COVID-19 booster campaign — with something new for this year.

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

This is the first updated COVID-19 vaccine approved in the United States.

Next up will be an advisory committee from the Centers for Disease Control and Prevention (CDC). Meeting on September 1st to provide recommendations on which groups should receive these updated boosters.

The CDC director must also sign off on the boosters before they can be released to the public. Once that happens, the updated boosters could be available to the public early to mid-September.

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

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

Nevertheless, dr. David Cutlera primary care physician at the Providence Saint John Health Center in Santa Monica, Calif., told Healthline that current vaccines continue to provide strong protection against serious illness and death.

This is especially true for the boosters.

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

Among people aged 50 and over, unvaccinated people were 14 times more likely to die from COVID-19 than those who 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 show CDC datathese still offer strong protection against serious diseases caused by Omicron.

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

“We believe that the Omicron-specific boosters will improve immunity against the existing Omicron variants. This may be particularly helpful during the expected winter tide,” said Dr. Jimmy Johna 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 offer greater protection than the current ones.

Cutler believes that the greatest benefit of Omicron-specific booster shots is for people who are unvaccinated or have not received the full primary series and all booster shots for which they are eligible.

Data presented to an FDA Vaccination Advisory Board meeting in June 2022 suggests that vaccination with a variant-specific booster – such as one targeting Omicron – could result in a “broadened antibody response” to the coronavirus.

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

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

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

But in this case, the updated boosters should suit the local situation. The Omicron BA.5 subvariant is still widespread in the United States – with a lower distribution than BA.4 – and should still be spreading until the introduction of the updated boosters.

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

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

These companies’ bivalent boosters are expected to be available in early to mid-September, Dr. Ashish Jha, Coordinator of the White House COVID-19 Response Team, said in a virtual discussion with the US Chamber of Commerce Foundation on August 16.

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

The company announced the next month that this was the case applied for FDA approval of this vaccine as a booster dose. It is also testing an Omicron-specific vaccine and a bivalent vaccine targeting Omicron and the original strain, the company said in a press release.

All currently eligible for a COVID-19 refresher are still eligible for those refreshers, including:

  • First Booster: everyone from the age of 5 who has completed their basic series
  • Second booster dose: adults 50 years and older; and some individuals 12 years of age and older who are moderately or severely immunocompromised

Johannes said anyone at risk of severe COVID-19 or complications from coronavirus infection should consider a booster when the bivalent vaccine becomes available.

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

So is the Biden administration expected to open the second booster This applies to adults under the age of 50 when the bivalent vaccines are available. That extension of eligibility was put on hold when vaccine makers said they could ship the bivalent vaccines in early fall.

When the bivalent boosters are available, the following people will be available justified to get them:

  • Pfizer-BioNTech bivalent booster vaccination: Persons aged 12 and over, at least 2 months after completion of the basic immunization or receipt of a booster vaccination with the original vaccine
  • Bivalent Moderna booster vaccination: Persons aged 18 and over, at least 2 months after completion of the primary immunization or after receiving a booster vaccination with the original vaccine

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

It should be noted that pregnant women continue to be considered for refresher vaccinations and basic immunization.

“That [COVID-19 mRNA] Vaccines have now been administered tens of million pregnant women. They are extremely safe, ”said JHA during the online discussion of the Chamber of Commerce. “We saw little or no side effects [in pregnant women]the same side effects that most of us get – the sore arm, sometimes 24 hour fatigue or a bit run down.”

Strengthening the security profile of these vaccines, a large to learn from Canada published on August 17, 2022 in The BMJ found that women who received a COVID-19 vaccine during pregnancy were not at higher risk of having a preterm birth, a baby born small for their gestational age, or stillbirth.

Vaccines are likely to be available in medical practices and pharmacies. Some mass vaccinations can also take place in certain places.

To find a vaccination point near you, visit the federal government Vaccines.gov Or on the Covid 19 vaccine website of your state.

It’s difficult to know what the coronavirus will do in the fall – will there be a big surge in early September, or will a new variant emerge?

Therefore, the CDC recommends You will be topped up once you are eligible, with the available booster. This is particularly important for adults aged 50 and over or people with a weakened immune system.

It can take a while one to two weeks after receiving a refresher vaccination so that your immune system is fully prepared. So if you’re eligible now and topped up, you’ll be better protected should cases pick up as we head into the fall and winter.

You can always get the bivalent vaccine when it is available. JHA said they should distribute these two booster “at least a little, probably 4 to 8 weeks”.

The CDC can also influence the timing between boosters if it checks the data for the Omicron-specific boosters.

Jha said if you’re planning to get seasonal flu shots this fall, you can definitely get that along with a COVID-19 booster.

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

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

At this time it does not appear that the bivalent vaccine will be used for unvaccinated individuals.

Although the FDA has asked vaccine manufacturers to update their boosters to include an Omicron-specific component, it is didn’t advise her to update the vaccine for the primary series.

In addition, the agency announced on August 31 that the original COVID-19 vaccines will continue to be used for the primary series for individuals aged 6 months and older.

Comments are closed.