Vaccines for Children: List By Age, Benefits, Safety

What Is Myocarditis? What To Know About Heart Risk Warning Related To COVID-19 Vaccines

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FDA Issues Heart Risk Warning For Pfizer And Moderna Covid Vaccines

The Food and Drug Administration (FDA) has required Pfizer and Moderna to expand the warning labels on their mRNA COVID-19 vaccines to highlight the risk of myocarditis and pericarditis, cardiac inflammation conditions, mainly found in males between the age of 16-25.

The updated incidence is 38 cases per million doses, up from previous alerts focusing on younger age groups 12–17 (Pfizer) and 18–24 (Moderna).

This update comes after FDA analysis of 2023–2024 data, including insurance claims and research showing several patients with previous cardiac MRI changes five months following the diagnosis.

The CDC further mentioned that the number of cases remains low, which is usually mild, and less severe as compared to the conditions caused by COVID-19 itself.

This significant change underscores efforts by Health Secretary Robert F. Kennedy Jr.'s administration to restrict vaccine oversight.

To note, Kennedy recently replaced all CDC advisory panel members with leading intellectuals.

The FDA Commissioner has also limited the annual vaccine shots for vulnerable people.

Critics claim the warnings omit critical context, highlighting evidence that COVID-19 infection consists of a significantly increased myocarditis risk 16-fold greater.

Furthermore, health experts, including Dr. Robert Morris, issued a warning for the FDA's latest approach and stressed the need for more research to identify the vulnerable population instead of broad label changes.

ACIP Skips Votes On COVID And Moderna's MRESVIA But Scrutinzes MRNA Vaccine Safety

The CDC's highly influential Advisory Committee on Immunization Practices skipped at least two key votes that were once expected to be on the agenda for this week's meeting. One was on overall COVID-19 vaccine recommendations, while the other was on the expanded use of Moderna's RSV vaccine mRESVIA, which earlier this month got an FDA greenlight for use in at-risk adults aged 18 through 59 years. Notably, both votes would have largely centered on vaccines that rely on mRNA technology.

On June 9, Health and Human Services Secretary Robert F. Kennedy Jr. Ousted all 17 ACIP members, replacing them days later with eight new advisors, many of whom have histories of anti-vaccine viewpoints. Despite not voting on either COVID-19 vaccines or mRESVIA, Truist Securities analysts said that the revamped committee "delivered as expected" at its first meeting spanning Wednesday and Thursday this week.

"New ACIP has a bone to pick with mRNA vaccines," the analysts wrote to investors on Thursday. "Going forward, we expect ACIP to continue picking on safety issues as a backchannel to anti-vax agendas."

Indeed, much of the discussion on the first day of the panel focused on mRNA safety research, with new ACIP member Robert Malone, an early mRNA vaccine researcher turned skeptic, questioning the safety of these vaccines. At one point during the committee's meeting on Wednesday he falsely suggested that mRNA vaccine epitopes stay in the body for upwards of "700 days." That comment came after a presentation from Sarah Meyer, the director of the CDC's Immunization Safety Office, showing that mRNA vaccines for COVID-19 are protective.

Despite the time spent discussing mRNA technology, no such vaccines received an ACIP vote. Following ACIP's April meeting under the previous committee members, William Blair analysts had predicted that an on-time approval of mRESVIA would lead to its addition to the ACIP's June agenda. That didn't happen. Notably, the committee did vote in favor of recommending Merck's recently approved RSV-targeting monoclonal antibody Enflonsia for infants less than eight months old who are not protected by maternal antibodies.

The committee also skipped a vote on COVID-19 shots, because Kennedy had already announced that the CDC would be removing recommendations for routine COVID-19 vaccinations for healthy children and healthy pregnant women from its guidelines—something that appeared to catch CDC staff off-guard and which still has not been fully implemented on the CDC site.

Meanwhile, the FDA approved updated warning labels for Pfizer/BioNTech's and Moderna's mRNA-based COVID-19 vaccines to include additional information about the risk of myocarditis, a rare heart side effect seen primarily in young men.

"Our mRNA vaccine outlook is that it will continue to be more scrutinized, relative to other vaccines," Truist analysts wrote. "The ACIP encouraged the presenters to look closer on safety, and avoid overvaluing the benefits."

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