Small remarks -WSJ: Covid vaccines for children approved too quickly

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The Wall Street Journal published an article raising troubling questions about the Food and Drug Administration’s approval of Pfizer’s and Modern’s Covid-19 vaccines for children. It’s signed by Allysia Finley, a member of the newspaper’s editorial staff, not just any quisling. We report large excerpts from the memo from the authoritative American media.

“This is a historic milestone, a monumental step forward,” President Biden said last week after the Food and Drug Administration approved Pfizer and Moderna vaccines for toddlers. “The United States is now the first country in the world to offer safe and effective Covid-19 vaccines for babies as young as 6 months.”

In fact, we do not know if vaccines are safe and effective. Hasty FDA approval is based on extremely weak evidence. It is one thing to have regulatory flexibility during an emergency. But there is no emergency for Covid children. The FDA has bent its standards to an unusual level, overriding worrying evidence that deserves further investigation.

As originally done for adults, the FDA has granted Pfizer and Moderna infant vaccines an emergency use permit, allowing the agency to expedite access to products that “prevent serious or dangerous diseases or conditions. For life.” While Covid vaccines for adults were clearly within this standard as early as the end of 2020, vaccines for younger children did not.

Only 209 children between the ages of 6 months and 4 years have died from Covid – about 0.02% of all deaths caused by viruses in the United States. Between October 2020 and September 2021, about half of the young children were hospitalized with Covid compared to those hospitalized due to influenza in the previous winter.

Other children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-2020 flu season. None of the approximately 5,400 young children involved in the Moderna trials have been hospitalized because of Covid. Yet at least 15 of them were hospitalized for non-Covid infections.

The two children in the Pfizer trial who became most ill from Covid also tested positive for other viruses. It is possible that many admissions attributed to Covid this winter have actually been spurred on or exacerbated by other viruses. Doctors had actually warned that the most “immunologically weak” children would be at risk once the schools reopened and the blockade was lifted.

There was very strong evidence for the efficacy of Moderna and Pfizer vaccines in adults at the time of approval. Both studies were large and robust enough to demonstrate 95% efficacy against infections with a good degree of certainty.

Instead, the FDA approved vaccines for young children based on a comparison of the antibodies they generated against the original Wuhan variant, comparing them with those from young adults who had received two doses. However, the two doses alone provide little or no protection against Omicron infection in adults, and even protection against hospitalization is only about 40% -60%.

If nothing else, the Moderna study showed effect, albeit modest, on Omicron symptomatic infection: 37% among children aged 2 to 5 years and 51% for those aged 6 months and 2 years.

Pfizer, on the other hand, said its vaccine was 80% effective, but that is misleading. First, Pfizer violated several clinical trial conventions.

His original protocol was for two doses only, but these could not generate the antibody levels required for FDA approval. Then Pfizer added a third dose, which the FDA generously approved. Normally, the agency does not allow drug manufacturers to make a price correction when a process has ended in failure.

Pfizer therefore plans to monitor at least 21 cases to determine effectiveness [del vaccino]Moderna instead monitored more than 250 of them. Pfizer then discontinued its data collection on April 29, the day after Moderna announced that it had applied for an emergency use permit, even though the cases recorded with the third dose were only 10 [si riferisce sempre a Pfizer ndr].

It’s hard not to conclude that Pfizer took every shortcut to avoid being beaten by Moderna. However, as a result, it has documented too few cases to measure the effectiveness of the Pfizer vaccine with any degree of confidence.

Despite this, Pfizer said their vaccine is 80% effective. Researchers should stand up. A Pfizer spokesman says the FDA was more interested in the vaccine’s “immunogenicity” data than its effectiveness in young children and will conduct another efficacy analysis as more cases have accumulated.

More worrying was that the vaccinated children in Pfizer’s study were more likely to become seriously ill with Covid than those given placebo. Pfizer said the more serious cases were not “clinically significant”, whatever that means, it was another reason why the FDA required a follow up longer before the vaccine is approved.

Additional concern: Most of the children who developed multiple infections during the trial were vaccinated. Further studies are therefore warranted because experimental vaccines sometimes increase susceptibility to infections by other diseases.

Researchers also find that adults with triple doses of the vaccine, who were previously infected with the Wuhan variant, have a weaker immune response to Omicron, making them more susceptible to re-infection. This phenomenon, called ‘immunological imprinting’, could explain why children who received three doses of Pfizer were more likely to become re-infected.

The FDA ignored the risk that inoculating children against a variant that no longer circulates could weaken their immune response to Micron and its derivatives. There is a reason why vaccine trials usually take a decade. Some steps can be accelerated, but one follow up expanded to ensure that potential side effects are not overlooked.

The FDA standard for the approval of vaccines for healthy people, especially children, should be higher than for medicines that treat the sick. But the FDA has dramatically lowered its standards for approving Covid vaccines for toddlers. Why? Maybe he felt the pressure from the White House and anxious parents. That Coordinated Covid responser from the White House Ashish Jha repeatedly told parents that he expected vaccines for younger children to be approved and available in June.

Remember how Biden accused Donald Trump of lobbying the FDA for speeding up the approval of the Covid vaccine, suggesting they might have been available before the November 2020 election. [furono annunciati il giorno dopo le elezioni! ndr].

Sir. The hypocrisy of the bite is hard to digest. The FDA, to its credit, accelerated Covid treatments and vaccines when they were desperately needed. But for children, it would have been better if the FDA had taken longer to ensure that the vaccines were actually safe and effective, even if it meant the United States would not be the first to get them.

Ps. What is approved in America will also be approved without reservation in the EU …

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