FDA and CDC Vaccine Experts Now Claim They are “Outraged” at Government and Moderna for Allegedly Hiding Key Data About Updated Booster Effectiveness – Moderna Responds
In August 2021, the Food and Drug Administration (FDA) gave emergency authorization to the new booster shot called “bivalent.”
The new vaccine contains two messenger RNA (mRNA) components of the coronavirus. Half of the vaccine targets the original strain, and the other half targets the BA.4 and BA.5 Omicron subvariant lineages.
The new COVID boosters were not tested on humans at the time, only on mice. FDA was only relying on the mice trial data.
The CDC panel then voted to recommend the shots for people over the age of 12 and for children as young as 5 to 11.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible,” he added.
However, two independent studies conducted by scientists from Columbia University in New York City and Harvard University found that the new boosters did not produce a better antibody response in humans against BA.5 than the first-generation vaccines.
They compared samples from 21 patients in the Columbia research and 18 people in the Harvard study who received the new boosters to people who received the old vaccine as their fourth shot.
One of the FDA’s vaccine experts immediately issued a statement saying these two studies are “small and subject to limitations.”
“Dr. Peter Marks, head of the FDA’s vaccine division, said the studies are small and subject to limitations. Data from larger well-controlled studies are expected in the near future, he said. Pfizer and Moderna are conducting clinical trials on the new boosters and are expected to provide data later this year,” NBC reported.
Now, a report from CNN claimed that some members of the government advisory panel on vaccines had expressed disappointment after government scientists and Moderna did not present a set of infection data on the company’s new Covid-19 booster during a meeting last year.
CNN spoke with six experts from the FDA and the CDC, and all of them agreed that despite the data’s limitations, it should have been presented to them.
“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” said Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee.
“It’s not a group of children. We understand how to interpret these results,” said Dr. Eric Rubin, a member of the FDA vaccine advisory committee.
“There should always be full transparency,” said Dr. Arnold Monto, acting chair of the FDA advisers’ group. “These data should not be dismissed. They are early, but they indicate that we need to look at them and see what their value is.”
If the data “was looked at as part of the study, it should have been presented to the advisers prior to their decision,” said Dr. Pablo Sanchez, a member of the Advisory Committee on Immunization Practices at the CDC.
CNN reported:
Some vaccine advisers to the federal government say they’re “disappointed” and “angry” that government scientists and the pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when the advisers discussed whether the shot should be authorized and made available to the public.
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.
https://www.thegatewaypundit.com/2023/01/fda-cdc-vaccine-experts-now-claim-outraged-moderna-allegedly-hiding-key-data-updated-booster-effectiveness-moderna-responds/