The FDA 178th Meeting of the Vaccine and Related Biological Products Advisory Committee will meet in open session January 26, 2023 to discuss future Covid-19 vaccination regimens. The meeting will run between 8:30 AM-5:30 PM ET.
Tag: fda advisory committee
CDC Identifies Preliminary Covid-19 Vaccine Safety Signal
The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:
“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.
This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:
- A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
- A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
- The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
- Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
- Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”
The CDC says it’s “very unlikely that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
No changes are recommended to the current Covid-19 vaccination practice:
“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:
- Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
- Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
- Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.
Overall safety data for the bivalent COVID-19 vaccines are available here.
Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”
FDA Advisory Committee Approves Adding Omicron component to the Next Covid-19 Vaccine
On June 28, 2022 the FDA Vaccine and Related Biological Products Advisory Committee came to a majority “yes” vote to the question:
“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”
The meeting was recorded and is available for review.
FDA Advisory Committee Meeting on June 7, 2022 for New Covid-19 Vaccine
The FDA Advisory Committee will meet on June 7, 2022, 8:30 AM – 5:00 PM ET to discuss the Novavax Covid-19 vaccine EUA application.
The vaccine is a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2rS) with Matrix-M1 Adjuvant.
Second Covid Vaccine Booster Got Any Mojo?
Tomorrow’s April Fool’s Day and I thought I’d get this post up today so it wouldn’t get confused with a joke.
I’m genuinely a little confused about the FDA and CDC approval of the 2nd Covid vaccine booster. It’s almost like this vaccine is getting a mojo of some kind, at least with some experts.
Although I’m not keen on getting another jab, I’ll do it if there is reasonable evidence to support it. Not everyone on the FDA Advisory committee is for it. Dr. Paul Offit was quoted in a news story as saying, “We’re going to have to learn to live with mild disease at some point.”
Dr. Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. I’ve heard him speak at FDA Advisory Committee meetings during public Zoom meetings on the subject and I respect his opinion. He doesn’t think frequent boosting is a reasonable thing to do. I’m inclined to agree with his opinion that most people won’t do it anyway. I’m sure he’ll have more to say at the April 6 FDA Covid Vaccine Advisory Committee meeting.
I was not surprised to learn that of the 90 million Americans who got their initial Covid vaccine series, only about half got the first booster. What kind of mojo is that?
Even the Pfizer drug company CEO, Albert Bourla, says frequent boosting is impractical.
There is some serious doubt in my mind about the booster mojo. Sena says that it would be helpful if more local infectious disease experts would express their own opinions about the direction this vaccination strategy is going. She has a point.
Does the Covid vaccine booster have any mojo? What do you think?
Featured image picture credit: pixydotorg.
FDA Advisory Committee Meeting on Covid Vaccine Boosters Scheduled for April 6, 2022
The FDA Advisory Committee on Vaccines and Related Biological Products has scheduled a meeting on April 6, 2022 “to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.” The meeting will run from 8:30 AM-5:00 PM ET.
FDA Postpones Meeting to Discuss Pfizer Covid-19 Vaccine for Children Less Than 5 years Old
The FDA announced today that the meeting to discuss Pfizer’s request for authorization of Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age, originally scheduled February 15, 2022, will be postponed. This will give Pfizer time to evaluate a third dose of the vaccine in this age group.
FDA Advisory Meeting on Covid-19 Vaccine for Children Less than 5 years Old
The FDA Advisory Committee will meet February 15, 2022 between 8:30 AM-5:00 PM ET to discuss Pfizer’s proposal to amend the Emergency Use Authorization for administration of the Covid-19 vaccine to children between 6 months through 4 years of age.
Public Notice of Gratitude to FDA & CDC Advisory Committees
I have watched a few YouTube presentations by the CDC and FDA Advisory Committees in the last few weeks. I’m very impressed with the professionalism, sincerity, civility, and dedication of the members of both organizations. The most recent FDA meeting on the extension of the EUA for the Pfizer COVID-19 vaccine to children ages 5-11 was a great example of the best of the best. It’s a tough job. I appreciate them. They also have a pretty good sense of humor, especially when they forget to unmute their microphones.
FDA Advisory Committee Meeting Today on Pfizer COVID-19 Vaccine for Children Ages 5-11
The meeting will go from 7:30 AM-5:00 PM, ET, and the Voting Question will be:
“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.
This is about extending the EUA for the Pfizer vaccine for this age group. It would be administered as a 2-dose vaccine, 10 micrograms each, 3 weeks apart. COVID-19 causes substantial morbidity and mortality in this age group.
Unlike the other recent FDA presentations I’ve seen, today there was a reminder that, in view of the polarized opinions pro and con about this question, all participants should do their best to observe the utmost civility at all times during the proceedings.
Dr. Fiona Havers presented the epidemiology of COVID-19 in this age group. It showed increasing infections and severe disease and hospitalization rates, which were higher among African American and other minority children than among white. Secondary transmission can and does occur among children and adults. See the slides.
Dr. Matthew Oster’s presentation on mRNA vaccine associated myocarditis showed that myocarditis is a rare but important adverse event following COVID-19 vaccination. See the slides.
Break.
The Pfizer presentation highlighted safety and efficacy data for the vaccine. See Dr. Gruber’s briefing document and slides. The FDA presentation by Dr. Leslie Ball, MD, summarized the immunogenicity and safety data (see summary slides 34 and 35). The supplemental descriptive efficacy analysis showed 90.7% vaccine effectiveness against symptomatic COVID-19 after the second dose. There were no cases of myocarditis/pericarditis after the data cutoff time.
FDA presenter Dr. Hong Yang, PhD presented the Benefit-Risk Analysis. Slide 22 summary:
“• For Scenarios 1 (Base), 2 (Recent COVID-19 Peak Incidence), 4 (Higher Vaccine Efficacy), 5 (Higher COVID-19 Death Rate), and 6 (Lower Excess Myocarditis Rate) the model predicts that benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks for ages 5-11 years.
• For Scenario 3 (The Lowest COVID-19 Incidence), the model predicts more excess hospitalizations and ICU stays due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations and ICU stays due to COVID-19 in males and in both sexes combined.
• Considering the different implications and length of stay for COVID-19 hospitalization versus hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention of cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario.
• If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable.”
“Major Limitations of the Benefit/Risk Model:
• Model assumption about constant incidence rate generates great uncertainty on the estimate of benefits.
• Vaccine efficacy may change due to new emerging variants of virus
• Hospitalizations and ICU stays from COVID-19 and myocarditis are not equivalent and cannot directly compared
• The benefit of reducing COVID related multisystem inflammatory syndrome in children may not be fully captured by preventable hospitalizations, ICU stays and deaths due to COVID-19
• This BR risk assessment does not consider potential long-term adverse effects due to either COVID-19 or myocarditis
• This BR assessment does not include secondary benefits (reducing COVID-19 disease transmission) and risks”
Break.
There were complicated questions about the applicability of the Benefit/Risk model assumptions, partly because it can be influenced by a low incidence of disease-readily acknowledged by the presenter, Dr. Yang. After extensive discussion, including the about the number of doses (One or Two?), concern for the difficult decisions this presents to parents (not just related to side effects), concern about the FDA approval being interpreted as a mandate, discomfort with the binary choice-type question.
A representative from the CDC Advisory Committee (ACIP) expressed that it seems the benefits outweigh the risks. The ACIP representative summarized the safety monitoring and reporting systems available, including but not limited to Vaccine Adverse Effects Reporting System (VAERS). The FDA can make a broad authorization; the ACIP (which may meet on this issue as soon as next week) can make implementation recommendations that could be more restrictive but could not be broader. University of Iowa representative, coronavirus expert with over 40 years’ experience and temporary voting member Dr. Stanley Perlman, indicated, in light of the thorough discussion, that he would vote in favor of the question.
“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.
The Vote: The votes were 94% (17) Yes, and there was one abstention, out of 18 votes.
The meeting was formally adjourned at 4:35 PM, ET.
Go Retire Psychiatrist 