FDA OKs New COVID Boosters

FDA OKs New COVID Boosters

FDA Approves COVID-19 Boosters: A New Weapon in the Battle Against the Virus

In a significant move, the U.S. Food and Drug Administration (FDA) has given the green light for new COVID boosters to become available within days. This development marks a crucial step forward in the ongoing fight against the virus.

The COVID-19 shots from Pfizer and Moderna have undergone rigorous scientific evaluation, meeting the FDA’s strict standards for safety, effectiveness, and manufacturing quality. These updated vaccines are fully approved for individuals aged 12 and older, with emergency use authorization granted for those between 6 months and 11 years of age.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of vaccination in protecting against severe consequences such as hospitalization and death. He stated, “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

Boosters for Vulnerable Americans

The approval of these boosters is particularly significant for vulnerable Americans. According to Dr. Amesh Adalja, a senior scholar at Johns Hopkins’ Center for Health Security, having an updated booster that closely matches circulating strains is an important tool for high-risk individuals. Such individuals still face the risk of severe disease, hospitalization, and death.

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The Road Ahead

The Advisory Committee on Immunization Practices is scheduled to meet soon to make recommendations on who should receive the new booster shots. Dr. Mandy Cohen, director of the U.S. Centers for Disease Control and Prevention, is expected to provide her approval shortly after, allowing vaccinations to commence.

Eligibility Criteria

The FDA has recommended the following eligibility guidelines for Americans:

• Individuals aged 5 and older, regardless of previous vaccination status, can receive a single dose of an updated COVID vaccine at least two months after the last dose of any COVID vaccine.
• Individuals aged 6 months through 4 years who have been vaccinated against COVID can receive one or two doses of an updated COVID vaccine, depending on the previous vaccine received.
• Unvaccinated individuals aged 6 months through 4 years can receive three doses of the updated Pfizer COVID vaccine or two doses of the updated Moderna COVID vaccine.

Targeting the Omicron Subvariant

The boosters target the XBB.1.5 Omicron subvariant, which is no longer the dominant variant circulating. However, closely related variants are spreading widely, and health experts confirm that this booster will still provide some protection.

Tackling COVID-19 Season

Albert Bourla, Pfizer Chairman and CEO, stated, “Now, most people 6 months or older in the U.S. are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before.” He highlighted the convenience of receiving the COVID-19 vaccine alongside the annual flu shot, as they can be administered during the same appointment, saving time and helping to prevent severe disease later when respiratory viruses are at their peak.

Moderna CEO Stéphane Bancel echoed this sentiment, emphasizing the importance of updated vaccines in protecting the population during this season of evolving strains.

The Cost of Boosters

While these COVID-19 boosters are invaluable in strengthening protection against the virus, they come at a price. For the first time, the federal government will not be covering the costs of the shots.

Most people with private and public health insurance should still be able to receive the boosters for free. Uninsured individuals may be able to access them at community health centers. However, some may need to pay. NBC News reports that the full price is expected to be $110 to $130 per dose.

Jennifer Kates, director of the Global Health & HIV Policy Program at KFF, a nonprofit health policy organization, explains that coverage and availability of the shots will depend on individual insurance plans.

To ensure access for uninsured individuals, the Biden administration has established a “bridge” program that offers free boosters through 2024.

The approval of these COVID-19 boosters by the FDA marks an important milestone in the ongoing battle against the virus. With vaccination playing a critical role in mitigating the risk of severe disease, hospitalization, and death, it is crucial for eligible individuals to consider getting vaccinated. These boosters, specifically tailored to the evolving strains, will provide an extra layer of protection as we navigate the challenging COVID-19 season.