FDA Approved New Covid Booster Vaccine: All About It

On Monday, the Food and Drug Administration approved updated COVID boosters produced by Pfizer and Moderna. These booster shots, specifically designed to target the XBB.1.5 subvariant, are anticipated to become available later this week, pending approval from the Centers for Disease Control and Prevention.

The FDA announced that individuals aged 5 and above are eligible to receive an updated booster shot from either Pfizer-BioNTech or Moderna, irrespective of their prior vaccination status. Individuals who have previously been vaccinated are advised to wait a minimum of two months after their most recent COVID-19 shot before obtaining the new booster.

In contrast, Novavax, a manufacturer of COVID vaccines, stated on Monday that its updated booster is still undergoing evaluation by the FDA. Unlike Pfizer and Moderna, Novavax’s vaccine does not employ mRNA technology.

These boosters arrive at a time when COVID cases are on the rise in the United States, driven by an array of subvariants. Health officials are hopeful that these boosters will help mitigate the potential surge in winter illnesses.

Here is what you need to know about these new booster shots.

What is the Effectiveness of the New Covid Booster Vaccine?

Back in June, the FDA requested drug manufacturers to develop fall boosters targeting the then-dominant XBB.1.5 subvariant.

Although this particular strain has since become less prevalent, constituting only about 3% of new COVID cases as of the week ending September 2, according to the CDC, other strains currently in circulation remain closely related to XBB.1.5.

Among these predominant strains, EG.5 accounts for roughly 22% of new cases, while FL.1.5.1 accounts for about 15% of new cases. Both belong to the XBB subvariant family. Pfizer, Moderna, and Novavax have all stated that their boosters are effective against EG.5, with Moderna also indicating efficacy against FL.1.51.

Dr. Eric Topol, the Executive Vice President of Scripps Research in La Jolla, California, expressed confidence in vaccine effectiveness, emphasizing that the vaccines developed thus far consistently demonstrate their ability to protect against severe illness, hospitalization, and death.

“The new booster will certainly enhance protection,” Dr. Topol affirmed.

Additionally, experts are closely monitoring BA.2.86, colloquially known as “Pirola” on social media, which is an omicron subvariant initially raising concerns due to its high number of mutations. However, emerging laboratory data suggests it may not possess the immune-evasive or transmissible properties initially feared.

Recent statements from Moderna and Pfizer indicate that their boosters appear effective against BA.2.86, as they trigger a robust antibody response against this variant.

Dr. Dan Barouch, the Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, highlighted that recent laboratory studies indicate individuals previously infected with an XBB omicron subvariant within the last six months produced antibodies against EG.5, BA.2.86, and other omicron subvariants. This suggests that the updated booster will likely offer protection against these strains as well.

Dr. Barouch stated, “The XBB.1.5 monovalent vaccines will likely elicit antibody responses against all currently circulating variants.”

New COVID Booster Vaccine
New COVID Booster Vaccine

When Should I Receive the New Booster?

A CDC advisory committee is set to convene on Tuesday to vote on recommendations regarding booster eligibility. Following this, CDC Director Dr. Mandy Cohen is anticipated to approve these recommendations, thereby initiating the booster administration.

For individuals who have not received a booster since the previous autumn and have not recently contracted COVID-19, experts advise getting the booster as soon as possible.

However, with the surge in cases, a significant number of individuals are currently battling COVID-19 or have recently recovered from an infection. According to a CDC representative, those who have recently been infected may consider waiting approximately 90 days from the onset of their illness before pursuing the booster.

Additionally, unvaccinated individuals are also eligible to receive the booster and are not required to complete a multi-dose primary series beforehand.

What Will be the Cost?

In a departure from the previous arrangement where the federal government covered vaccine costs, individuals will now be responsible for the expense.

Both Pfizer and Moderna have indicated a pricing exceeding $100 per vaccine dose.

Jennifer Kates, who directs the Global Health & HIV Policy Program at the nonprofit KFF, noted that the majority of individuals with private and public health insurance will likely not incur any out-of-pocket expenses for the boosters, provided they receive them from an in-network healthcare provider.

Kates explained, “If you go out of network, you might have some cost, just like with any other service.”

For those without insurance, estimated at around 30 million individuals in the U.S., access to a free booster should be available at community health centers. Moreover, the Biden administration is introducing a “bridge” program aimed at granting uninsured individuals access to free boosters, at least until the conclusion of 2024. However, those who are unaware of or lack access to these resources may need to cover the costs themselves.

How Many Booster Shots Will Be Necessary?

According to Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital and a member of the FDA’s advisory committee, the majority of healthy individuals are likely to require just one booster shot until the fall of 2024.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia and another member of the FDA’s advisory committee, noted that there’s a possibility individuals at a high risk of severe disease, such as older adults or those with compromised immune systems, may receive recommendations for an additional dose in a few months. He emphasized that these individuals commonly share one characteristic: they do not mount robust immune responses.

What Are The Potential Side Effects?

According to Levy, the side effects of the updated boosters should remain consistent with those observed with the previous versions of the vaccines.

Typical side effects encompass symptoms such as headache, chills, fever, nausea, and pain or swelling at the injection site, as indicated by the CDC.

It’s worth noting that Pfizer and Moderna’s vaccines have been linked to a slightly elevated risk of myocarditis, which is the inflammation of the heart muscle, primarily affecting young men. Most individuals experiencing this condition make a complete recovery, and initial research indicates that instances of myocarditis are most common following the second dose of the initial vaccine series.

Nevertheless, Pfizer and Moderna are currently conducting studies to monitor any potential health issues that may arise in the years following a diagnosis of vaccine-related heart problems.