Pfizer EUA At A Glance:
- Pfizer pulls EUA request for children 6 months-4years.
- Will wait for final data from 3-dose series in April.
- 971 public comments submitted ahead of VRBPAC meeting.
Just days before the FDA’s VRBPAC (Vaccines and Related Biological Products Advisory Committee) meeting to assess the data for Pfizer’s vaccines for the 6-24 month and the 2-4-year age groups, the company pulled its request for emergency use authorization. Just last week, the FDA initiated the submission of the request by asking Pfizer to submit the data to begin the approval process for two of the three dose regimen.
Back in December, Pfizer admitted the two doses didn’t produce the hoped-for immune response in the 2-4-year age group. They were to begin a third shot to see if that would illicit the response needed for the immune bridging study. Pfizer agreed to submit the data for the third doses when they became available in March or early April. This would allow the FDA and CDC to move forward and have children start with the two-dose series.
The White House has already purchased millions of doses and hoped to have them rolled out as early as February 21st. This isn’t the first time the White House rushed ahead of the science and created confusion for the vaccines. The last time, two FDA officials stepped down.
But Why The Delay by Pfizer?
There have been mixed reactions regarding the delay. Proponents of the vaccines are upset at the timing and pushing for children to receive these vaccines, even without the full data set. Opponents of the vaccine are grateful that, for once, the rush to push authorizations and approvals through have slowed down for data. According to the FDA’s statement:
The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
No mention as to what that data is, and what it may indicate has been given. Pfizer’s press release states:
The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
Ahead of next Tuesday’s VRBPAC meeting, the FDA was expected to have data published for review. The meeting has been cancelled, and no data has been released.
Could the FDA or Pfizer Be Hearing From the Opposition?
Public statement for the VRBPAC meeting was open for submission until yesterday, February 10th. There had been 971 comments submitted, many of them urging the FDA to slow down and not offer the EUA to the vaccines for these youngest Americans. This does not include the numerous people who were slated to speak out on the vaccines during the meeting.
According to an NBC report:
Two people familiar with the FDA’s plans said there had already been a lot of pushback on the agency from outside experts who had concerns that Pfizer’s data wasn’t sufficient. The experts felt, one of the people said, that their concerns were “falling on deaf ears” within the agency.
Hold the Phone — Doc’s Thoughts:
Finally! It may seem a small victory, but there has been time bought for these youngsters ahead of this failed, dangerous shot.
There’s been so much bad news. We’ve talked so much already about the damage that has been done to so many children. We’ve talked about how the severity of this virus has so much to do with the condition of the host and comorbidities. We’ve heard how this shot is specific to the original strains, and that Pfizer is creating an omicron specific vaccine. We’ve heard about ADE; considering these youngsters would likely be faced with a lifetime of boosters, that is a major concern. We’ve heard the devastating cases of nervous system disorders, blood clots, and myocarditis. We’ve seen many conditions normalized ahead of this vaccine rollout for these children. We’ve worried for our children’s mental health.
But maybe, maybe we’re turning this around. After all, countries are dropping their COVID policies. Omicron seems to be acting as nature’s own vaccine and booster for this virus. We’ve talked about natural immunity and the amazing, robust protection it offers to children. Maybe people are standing up more and more, and the agencies are starting to listen. They hear people defending their right to deny vaccines. They’ve seen the court cases lost. They are denied the right to withhold the data, we’ll get to see it 75 years sooner than they’d hoped. They see that people are becoming more and more educated on vaccine injuries. People ready to defend their freedoms and get involved in politics.
While so far we don’t know why the delay, today we can celebrate while staying diligent. We need to continue speaking out locally, getting involved, staying informed. You get to make the decision for your family. We can’t let up. We need to stay engaged until all of these dangerous vaccines are no longer authorized for emergency use when there is no emergency. We must be certain they’ll never make it on the vaccine schedule only to be protected from legal liability.
If you are concerned for your child’s immune response, we can help. The Wellness Way offers state of the art testing that will help you to make the choices to protect your child’s health. Before relying on a vaccine, consider the host and whether your child is truly at risk.