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‘Serious Doubt’ About COVID Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial Data
Conservative public interest advocacy group Defending the Republic has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”
As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained — and is releasing — nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.
Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.
As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first installment.
The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.
But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both the safety of Spikevax and the FDA’s standards for approval.
Neither Moderna nor the FDA immediately responded to a request for comment.
U.S. Military Confirms Myocarditis Spike After COVID Vaccine Introduction
Cases of myocarditis soared among U.S. service members in 2021, after the COVID-19 vaccines were rolled out, a top official has confirmed. There were 275 cases of myocarditis in 2021 — a 151% spike from the annual average from 2016 to 2020, Gilbert Cisneros Jr. said.
Mr. Cisneros, under secretary of defense for personnel and readiness, was confirming data revealed by a whistleblower earlier this year. Mr. Cisneros provided the rate of cases per 100,000 person years, a way to measure risk across a certain period of time. In 2021, the rate was 69.8 among those with prior infection, compared to 21.7 among members who had been vaccinated.
“This suggests that it was more likely to be [COVID-19] infection and not COVID-19 vaccination that was the cause,” Mr. Cisneros said.
Sen. Ron Johnson (R-Wis.), who has been investigating problems with the database, questioned how the military came up with the figures. “It is unclear whether or how it accounted for service members who had a prior COVID-19 infection and received a COVID-19 vaccination,” Sen. Johnson wrote to Mr. Cisneros. The Department of Defense (DoD) did not respond to a request for comment.
The CDC Is Preparing for a Winter With ‘3 Bugs out There’: Covid, Flu and RSV
Even as the nation is faced with blistering heat waves this summer, Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention (CDC), is already thinking ahead to cold and flu season this winter.
“We’re going to have three bugs out there, three viruses: Covid, of course, flu and RSV,” Cohen said in an interview. “We need to make sure the American people understand all three and what they can do to protect themselves.”
Spread of all three respiratory viruses is currently low, but the CDC has begun to detect slight increases in positive COVID-19 tests and COVID-19-related emergency department visits. And the decline in COVID-19 hospitalizations has stalled.
Omicron XBB subvariants remain the most prevalent forms of COVID-19, though on Wednesday, the World Health Organization identified a new XBB version, the EG.5, as rising in prevalence around the world and in the U.S.
For Over 1 in 10 Young U.S. Adults, Vaping Is a Regular Habit
About 11% of young adults in the United States now actively use electronic cigarettes, the Centers for Disease Control and Prevention (CDC) says in a new report. The report, from CDC’s National Center for Health Statistics, adds to growing concerns about the harms of vaping.
“If e-cigarettes were being used as we would hope, the only people who should use them are those who are using them to quit smoking,” said Dr. Joanna Cohen, director of the Institute for Global Tobacco Control at Johns Hopkins University in Baltimore, who was not involved with the new research. “You would see very different patterns,” Cohen told CNN.
Rather, young people who have never smoked cigarettes are the bulk of consumers.
Bavarian Nordic to Scrap RSV Vaccine After Study Setback
Since May, Pfizer and GSK have both brought RSV vaccines to market, and AstraZeneca and Sanofi have followed with a protective antibody drug.
Moderna has brought a shot to regulators as well, highlighting the fierce competition Bavarian Nordic has been up against. Already, one competitor, Johnson & Johnson, has bowed out despite having a vaccine in late-stage development. The Danish biotech is now following suit.
Its decision comes as the result of a Phase 3 study in more than 20,000 adults at least 60 years of age, a similar group to the one now cleared to receive Pfizer and GSK’s vaccines. The shot did meet one of its study goals, proving 59% effective at preventing at least two lower respiratory tract disease symptoms. But missing its other goal “was unexpected,” said the company’s president and CEO, Paul Chaplin, in a statement.