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.

FDA Advisory Committee on Janssen Booster and Heterologous Dosing: Day 2

Dr. Arnold Monto, Acting Chair “Arnie” couldn’t get his camera to work right off the bat on this, Day Two of the FDA Advisory Committee meeting on COVID-19 vaccine boosters. The microphone mute virus was also an issue—again. One committee member had real problems with audio skipping, which the on-screen captioning could not fix. There were many on-screen notices of “indiscernible,” as well as comical errors, “public urine speakers.” That captioning reminded me of voice recognition software, which I tried to use when I dictated my clinical notes.

Early in the meeting, Arnie asked for a clarification of the voting question:

“10/15 Voting Question:

Question 1) Do available data support the safety and effectiveness of Janssen COVID-19 Vaccine for use under EUA as a booster dose in individuals 18 years and older at least 2 months after a single dose primary vaccination?

1a. If yes to # 1, do available data support that an interval of at least 6 months between a single primary dose and a booster dose may result in a more robust booster response?

2b. If no to # 1, do available data support the safety and effectiveness of Janssen COVID-19 Vaccine for use under EUA as a booster dose in individuals 18 years and older at least 6 months after a single dose primary vaccination?”

This led to what Sena and I thought was a hilarious “clarification” interaction between Arnie and Dr. Peter Marks. We couldn’t really follow it, mainly because we couldn’t stop laughing.  It reminded me of the “Who’s on First” routine by Abbott and Costello. However, Arnie said he understood it.

The Q&A session between the committee, the sponsor, and FDA seemed conflicted about the data on the efficacy of the Janssen vaccine. The FDA received a large amount of data from Janssen, but apparently got it too late to conduct its own analysis of it. There was the overall impression that the Janssen vaccine efficacy is lower than the mRNA vaccines. The participants on both the FDA and the sponsor side acknowledged that maybe part of the reason to hold today’s meeting was in view of the urgency to do something for those patients who got the Janssen vaccine. Most people acknowledged that the Janssen vaccine had good durability. Arnie kept the proceedings on a short leash as usual, and by the break for lunch at 11:25 AM CDT, it wasn’t very clear what the outlook was for the Janssen booster.

I’ll update after the break.

Several committee members advanced the idea that the Janssen vaccine is actually best considered a 2-dose vaccine rather than a 1 dose vaccine. They moved toward not calling the 2nd dose as a booster per se, and also seemed agreeable to simplifying the voting question above to only number 1, setting aside the a and b questions. Arnie called out “We need a simplification” and the group went along with it. Dr. Perlman suggested that it might be helpful to hear the presentation about heterologous boosting prior to addressing the voting question; however, Arnie and Dr. Marks thought heterologous boosting might be addressed as a separate EUA in the near future.

The committee voted only on the revised question:

Question 1) Do available data support the safety and effectiveness of Janssen COVID-19 Vaccine for use under EUA as a booster dose in individuals 18 years and older at least 2 months after a single dose primary vaccination?

The above was upvoted unanimously. The word “booster” might be changed to something like 2nd dose later.

After a 15-minute break, the heterologous (mix and match) vaccine boosting presentation will be given. I’ll update after that.

After the presentation on heterologous boosting, it seemed like mRNA boosting was stronger than Janssen boosting. A limitation was that this was an antibody data study only. The committee was impressed with the safety data. The discussion question to the committee was about what other studies they would want to see in order to evaluate an EUA to help guide decisions on, for example, how to boost the Janssen vaccine. Not all members thought an EUA was necessary for this issue. It sounded like some members wanted to see some flexibility in allowing for a fact sheet that would provide clear guidance on how to use heterologous boosting. In fact, some heterologous boosting is already happening out in the real world, which members acknowledged.

The meeting was adjourned at 2:30 PM CDT on the proverbial and a celebratory “You’re muted” reminder.

FDA Advisory Committee Meeting on EUA for Moderna COVID-19 Vaccine Booster Today

Today I’m watching the FDA meeting on extending the Emergency Use Authorization (EUA) for Moderna COVID-19 Vaccine Booster application. Right now, I’m in-between presentations and I’ll be updating later this afternoon. I’m skipping the Open Public Hearing.

I’m wondering if the question to vote on will get changed like it did last month for the Pfizer booster. So far, today’s question is:

“10/14 Voting Question:

Question 1) Do available data support the safety and effectiveness of Moderna COVID-19 Vaccine for use under EUA as a booster dose (50 mcg mRNA-1273) at least 6 months after completion of a primary series in the following populations:

• Individuals 65 years of age and older,

• Individuals 18 through 64 years of age at high risk of severe COVID-19, and

• Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

Dr. Arnold Monto is in fine form and has already starting limiting the number of questions participants can ask. But we’re ahead of schedule and he’s very pleased overall.

My wife, Sena, finally got her Pfizer booster this morning. It has been kind of complicated for her to schedule and she went through a telephone algorithm about a half dozen times. She showed up on the day scheduled a couple of days ago and the pharmacy manager cancelled it, saying it was too early for the 6-month mark (by 2 days) following her 2nd primary series dose. This morning he apologized for being the “Vaccine Nazi.”

My Moderna booster depends on what happens today, and after the CDC advisory committee makes its decision at their meeting next week Oct 20-21. If approved, I’d get half the dose I received during my primary series (50 mcg instead of 100 mcg)—provided I don’t run into the Vaccine Nazi.

Anyway, this morning’s meeting went fairly well; only 2 people forgot to unmute their microphones. The Israeli researchers gave a presentation on their updated booster program that impressed committee members, who called the data “compelling.” As I recall, last month, some people raised questions about their definition of COVID-19 disease severity, making it hard to judge how applicable their data results would be in the United States. This morning, they clarified that the disease severity criteria actually came from the NIH (slide 15).

Update around 2:15 PM today: The committee upvoted the question above unanimously.

Tomorrow the committee will take up the issues of J&J boosters and heterologous vaccinations.

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