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FDA approves updated covid vaccines, but with severe new limits — The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax, but has imposed significant restrictions on their use, particularly for younger populations..

The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax, but has imposed significant restrictions on their use, particularly for younger populations.

FDA approves updated covid vaccines, but with severe new limit

FDA Approval Details

FDA approves updated covid vaccines but with — key context and updates inside.

On Wednesday, the Food and Drug Administration (FDA) granted approval for a new round of COVID-19 vaccines specifically targeting seniors aged 65 and older. However, the approval for individuals younger than 65 is limited to those who have “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” This marks a notable shift in vaccine eligibility criteria.

Changes to Pediatric Vaccination

In a significant move, the FDA has revoked the emergency use authorization for the Pfizer vaccine for children under the age of 5. This decision aligns with the broader trend of tightening vaccine access for younger populations, which has raised concerns among public health advocates.

CDC Leadership Shakeup

Following the FDA’s announcement, reports emerged from The Washington Post indicating that the Centers for Disease Control and Prevention (CDC) has ousted its director, Susan Monarez. This change was confirmed by the Department of Health and Human Services (HHS), now led by Robert F. Kennedy Jr., known for his long-standing anti-vaccine stance.

Response from Monarez’s Counsel

Mark Zaid, one of the lawyers representing Monarez, refuted claims of her resignation or termination. He stated, “Dr. Monarez has neither resigned nor yet been fired. She will not resign.” In a statement, Zaid expressed concerns over the politicization of public health:

“First it was independent advisory committees and career experts. Then it was the dismissal of seasoned scientists. Now, Secretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk.”

Zaid further emphasized that Monarez prioritized public health over political agendas, asserting her commitment to scientific integrity.

Resignations and Internal Turmoil

The Washington Post reported that Monarez faced pressure from Kennedy regarding her support for revising FDA policies. Additionally, at least three senior CDC officials, including Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases, and Debra Houry, chief medical officer, have announced plans to resign.

Impact on Vaccination Strategy

The recent changes in vaccination recommendations have already begun to affect public health strategies. In May, the government removed healthy pregnant individuals and children from the recommended list for COVID-19 vaccinations, a decision that CNN noted has hindered some people from getting vaccinated.

Barriers to Access

Kennedy has claimed that the new measures will ensure vaccine availability for those who need them most, particularly vulnerable populations. However, the requirement for millions of Americans to prove they are at risk poses an additional barrier to vaccination. This could complicate access for many who may not have underlying conditions but still wish to receive the vaccine.

Future Implications for Vaccine Distribution

The New York Times has reported that upcoming decisions from the CDC could significantly impact vaccine availability at pharmacy locations. In some states, laws mandate that CDC recommendations are necessary for pharmacy staff to administer vaccines. This could further complicate access to vaccinations, particularly for those who are not classified as high-risk.

Changes in Advisory Committees

In a related development, Kennedy recently dismissed 17 members from the Advisory Committee on Immunization Practices (ACIP), which is responsible for making vaccine recommendations. This move has raised concerns about the future direction of vaccination policies and the potential impact on public health.

As the landscape of COVID-19 vaccination continues to evolve, the implications of these recent decisions will likely be felt across various sectors of public health and community well-being.

fda approves updated covid vaccines but with — Source: Original report.