Category: Covid-19

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Fact check: FDA still recommends COVID-19 vaccines as safe, effective
April 28, 2023

The claim: The FDA says the COVID-19vaccine is 'unsafeand ineffective'

An April 23 Instagram post (direct link, archive link) features a black and white photo of two boxers, one throwing a punch that the other dodges.

3 entire years of Covid vaccine propaganda, reads text under the boxerthrowing the punch, while text underneath the dodging boxer reads, "Me."

The post's caption reads, "FDA NOW SAYSUNSAFE & INEFFECTIVE."

The post was liked more than 200 times in two days.

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The Food andDrug Administration still recommends COVID-19 vaccines. There is no indication the administration has saidthe COVID-19 vaccines are unsafe or ineffective.

There is no evidence the FDA has changed its stance on the safety and effectiveness of the COVID-19 vaccine. The administration continues to list four types of COVID-19 vaccines as authorizedfor emergency use or approved on its website.

Abby Capobianco, a spokesperson for the FDA,said the claim isfalse in an email to USA TODAY.

The FDA continuously and rigorously monitors data regarding the use of the monovalent and bivalent COVID-19 vaccines, and all the data shows that the vaccines are safe,she said.

The FDA announced on April 18 that it updated the emergency use authorization for the mRNA vaccines from Pfizer-BioNTech and Moderna to only include versions of the vaccine that target multiple strains of COVID-19. Those formulations, known as bivalent, have been more effective against the omicron variants of SARS-CoV-2, the virus causing COVID-19, compared to the monovalent version of the vaccine, which only targeted the original strain.

That change does not mean the monovalent vaccine was ineffective or unsafe, Capobianco said. Data from the Centers for Disease Control and Prevention shows both types of vaccines lowerthe chance of death from COVID-19.

Fact check: Switzerland modified COVID-19 vaccine recommendation. It didn't ban the vaccine.

Thedeath rates among unvaccinated people were 14 times those of bivalent vaccine recipients as omicron variants BA.4 and BA.5 surged, according to the data. Monovalent-only recipients had far lower mortality rates than the unvaccinated, but they were still 2.6 times higher than bivalent vaccine recipients.

USA TODAY reached out to the social media user who shared the claim for comment but did not immediately receive a response.

The Associated Press and AFP also debunked theclaim.

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Fact check: FDA still recommends COVID-19 vaccines as safe, effective

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Florida surgeon general altered Covid-19 vaccine analysis to suggest …
April 28, 2023

CNN

Florida Surgeon General Dr. Joseph Ladapo altered an analysis released by the Florida Department of Health last year to suggest mRNA Covid-19 vaccines pose a significant health risk to men ages 18 to 39, Politico reported Monday.

Politico said it obtained a document as part of a public records request that shows Ladapos changes to the eight-page analysis. The changes deleted comments that said a link with slightly increased risk of cardiac-related deaths after Covid-19 vaccination was no longer significant for multidose vaccines and there is little suggestion of any effect immediately following vaccination. The document shows an added line that says mRNA vaccines may be driving an increased risk of cardiac-related death in males, especially those ages 18-39.

The version released publicly in October 2022 said Covid-19 vaccination was associated with a modestly increased risk for cardiac-related mortality 28 days following vaccination, and says the vaccines may be driving the risk, especially among younger men.

In a statement to CNN, Ladapo said its typical for an assessment of surveillance data to include revisions, he has expertise and training to make these decisions, and the revisions were appropriate.

To say that I removed an analysis for a particular outcome is an implicit denial of the fact that the public has been the recipient of biased data and interpretations since the beginning of the mRNA COVID-19 vaccine campaign. I have never been afraid of disagreement with peers or media, Ladapos statement said.

The Florida analysis was not peer-reviewed or published in a medical journal, but was posted online by the Florida Department of Health and shared in a news release. Based on that analysis, Ladapo and the Department of Health released guidance that recommended against mRNA Covid-19 vaccines for males ages 18 to 39, saying the abnormally high risk of cardiac-related death among men in this age group, likely outweighed the benefits.

The state Department of Health said Tuesday that Ladapo stands by his guidance to recommend against the vaccine for certain groups.

Multiple studies have found cases of myocarditis and pericarditis, inflammation of the heart and heart lining, are rare after mRNA vaccines, although they are more likely to occur among young men. The risk of heart inflammation is far greater from Covid-19 than from vaccination.

Florida is an outlier in its recommendations against the Covid-19 vaccine for young men and healthy children; it is at odds with US Centers for Disease Control and Prevention, recommendations from other states and Floridas chapter of the American Academy of Pediatrics.

Following large clinical trials, the US Food and Drug Administration authorized the shots for use in people 6 months and older, and CDC continues to recommend them. Experts and government agencies say the benefits far outweigh the risks as the vaccines dramatically reduce the risk of hospitalization or death from Covid-19.

Ladapo has a history of vaccine skepticism, and since becoming surgeon general in Florida, supported Gov. Ron DeSantis plan to investigate wrongdoing in Florida with respect to Covid-19 vaccines by vaccine makers and supporters.

Early in the pandemic, DeSantis had advocated the need for vaccines, but his message changed since mid-2021, coinciding with skepticism among conservatives who have at times booed President Donald Trump for touting Covid-19 vaccines.

Excerpt from:

Florida surgeon general altered Covid-19 vaccine analysis to suggest ...

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Should You Get an Additional COVID-19 Bivalent Booster?
April 28, 2023

The number of cases of COVID-19 may be dropping, but the disease is still a concern for those who are 65 and older (more than 53 million people in the United States) and those with weak immune systems (about 7 million people). Those two groups are more likely than others to get severely ill or die from COVID-19thats why the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are offering a second bivalent booster shot.

This booster is identical to the reformulated, or "bivalent," booster introduced in fall 2022 in that it targets two virus strains: Omicron subvariants BA.4 and BA.5 and the original SARS-CoV-2 virus. The bivalent boosters are available from both Pfizer-BioNTech and Moderna.

I support the booster for those who are eligible and want to get it, says Yale Medicine infectious diseases specialist Scott Roberts, MD.

Studies have shown that COVID-19 vaccines can prevent COVID-related hospitalization and death. Whats more, the vast majority of the more than 1.1 million deaths from COVID-19 in the U.S. have been in people 50 and older, and the numbers increase with age, according to CDC data. Still, only 42.4% of people 65 and olderand 16.7% of all eligible people in the U.S.have gotten the first bivalent shot, according to the CDC. I consider that number to be quite poor, Dr. Roberts says.

As part of a bigger plan, the FDA also announced that the current bivalent mRNA vaccines will replace the original monovalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines, which target the original, or ancestral, SARS-CoV-2 virus strain; they are no longer authorized for use in the U.S.

The agency is also planning to further simplify future COVID-19 vaccinations by offering a reformulated booster for a vastly expanded age group in the fall, around the same time as the flu shot becomes available. That booster will be based on recommendations about current circulating SARS-CoV-2 virus strains.

Below, Dr. Roberts answered common questions about the FDA's decision to offer an additional COVID-19 booster to certain groups.

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Should You Get an Additional COVID-19 Bivalent Booster?

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