The Centers for Disease Control and Prevention (CDC) meeting took place one day after the US Food and Drug Administration (FDA) approved an increase in supportive injections.
The day before, the Food and Drug Administration issued an Emergency Use Authorization (EUA) that increased the number of vaccinated people who could receive the vaccine. This paved the way for the CDC to determine whether the FDA grant should be used as an official health policy.
Approval by the ACIP Advisory Committee is a key step in the CDC's policy process. While the CDC director does not have to follow ACIP's recommendations (and in particular did not act in accordance with the decision of the previous speaker), overcoming ACIP is unusual. Since ACIP has already voted unanimously to increase use of Moderna and J&J vaccine recipients, the CDC director will likely follow his advice.
FDA Paves the Way
On Wednesday, the Food and Drug Administration announced that it is expanding the EUA for the injection of the Covid-19 vaccine. Earlier this month, the FDA introduced Pfizer/BioNTech boosters to people six months after receiving their initial dose and at high risk of exposure (such as health care workers) or severe COVID cases (the elderly and those with health conditions) It has been confirmed. . The CDC accepted the guidance despite a vote of no-confidence on its advisory committee.
New FDA approvals give Moderna similar rules to Pfizer/BioNTech: For people over 65, those with medical conditions are approved. They are at risk or those who have a job that increases their exposure to infection. For those who have had a J&J shot, anyone over 18 can do so two months after their first procedure.Advertisements
The FDA is also highly effective based on combination evidence and game enhancers, and each of these three is a vaccine. The CDC sets policy based on the ACIP's recommendation for its preferred vaccination approach—although, as we saw earlier this month, the CDC director ignored some of the ACIP's recommendations. CDC guidelines are often followed by state and local health departments, insurance companies, and others, and thus have a significant impact on how FDA licenses are enforced.
Data, Lots of Data
Those concerned that not enough information is available about these vaccines - a group that unfortunately includes a new surgeon in Florida - will have to force them to submit ACIP hours to sit before the vote. We currently have several clinical trials (through industrial and government funding) and several platforms to track adverse reactions among vaccinators. And the numbers are sometimes staggering: Between clinical trials and the temporary surge, the CDC tracked nearly 11 million people who had already received booster doses to determine whether or not it would be open to the public. .
While it is impossible to cover all the data, there have been a number of recurring trends. The first is that the rate of side effects of boosters is not significantly different from the initial vaccination. The most important problems (carditis caused by RNA vaccines, clotting problems caused by J&J) are rare and no new problems have been identified. Most people have a mild fever, pain and/or fatigue.
The CDC's Advisory Board has unanimously approved a COVID vaccine boost
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