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Some vaccine advisors who were responsible for advising on federal policy on whether to authorize the COVID-19 booster shot have said they're "disappointed" and "angry" that government scientists and vaccine-maker Moderna neglected to present a set of infection data before the FDA could give their advisement.
The data in question suggested that the updated booster could be no more effective at preventing infection than the original shot.
Several advisors told CNN that the lack of transparency concerned them, given that almost 50 million people in the US have taken the shot, at a cost of nearly $5 million to taxpayers.
"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, a group of external advisers that helps the FDA make vaccine decisions.
"Decisions that are made for the public have to be made based on all available information -- not just some information, but all information," he added.
At several meetings last year, the advisors were presented with reams of information from Moderna, CDC and FDA officials about how much more effective the new vaccine was compared to the original one.
The data given was based on bloodwork samples to assess how well the vaccine fought off the more prevalent Omicron.
However, data showing who actually caught the virus and who didn't was not presented.
This infection data found that 3.2 percent of participants who received the updated vaccine became infected, compated to 1.9 percent who received the original booster.
Despite the data not being complete, it was included in a preprint study posted online in June and in an FDA document in September, as well as appearing in a top medical journal. The six advisors interviewed by CNN expressed frustration that this available data wasn't shared with them in that state, even though they all stated that it wouldn't have changed how they voted.
"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, a professor of epidemiology at the University of Michigan School of Public Health and 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."
Moderna spokesman Christopher Ridley told CNN that the information was made available online before the meetings. However, an FDA spokesman said that "the FDA received the preprint less than a day prior to the advisory committee meeting," and "the information was therefore not provided in an adequate timeframe for it to be included in the agency's meeting materials."
The data in question suggested that the updated booster could be no more effective at preventing infection than the original shot.
Several advisors told CNN that the lack of transparency concerned them, given that almost 50 million people in the US have taken the shot, at a cost of nearly $5 million to taxpayers.
"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, a group of external advisers that helps the FDA make vaccine decisions.
"Decisions that are made for the public have to be made based on all available information -- not just some information, but all information," he added.
At several meetings last year, the advisors were presented with reams of information from Moderna, CDC and FDA officials about how much more effective the new vaccine was compared to the original one.
The data given was based on bloodwork samples to assess how well the vaccine fought off the more prevalent Omicron.
However, data showing who actually caught the virus and who didn't was not presented.
This infection data found that 3.2 percent of participants who received the updated vaccine became infected, compated to 1.9 percent who received the original booster.
Despite the data not being complete, it was included in a preprint study posted online in June and in an FDA document in September, as well as appearing in a top medical journal. The six advisors interviewed by CNN expressed frustration that this available data wasn't shared with them in that state, even though they all stated that it wouldn't have changed how they voted.
"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, a professor of epidemiology at the University of Michigan School of Public Health and 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."
Moderna spokesman Christopher Ridley told CNN that the information was made available online before the meetings. However, an FDA spokesman said that "the FDA received the preprint less than a day prior to the advisory committee meeting," and "the information was therefore not provided in an adequate timeframe for it to be included in the agency's meeting materials."
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