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November 3, 2021

Pfizer Vaccine for 5-11 Year Old Children is Approved

The CDC ACIP Advisory Committee voted yesterday (14 to 0) to approve the Pfizer Covid Vaccine for 5 to 11 year old children.  Dr. Rochelle Walensky, CDC Director, approved it last evening and now the vaccinations can begin.  On Oct. 27th I reported on the FDA VRBPAC Committee Meeting and summarized the vaccine efficacy (90.7%) and safety data (Paper and Threads: FDA Approves Pfizer Covid Vaccine for 5-11 Year Olds).  At today's full day meeting a Pfizer scientist, CDC scientists, and other investigators reviewed the vaccine again in depth and did a formal benefit vs risk assessment before the committee ended the day with a unanimous vote for approval.

There have been >1.9 million cases of Covid in 5-11 yr. old children, more than 8,300 hospitalizations, 2,316 cases of MIS-C and over 100 deaths during the pandemic.  Many of the children are asymptomatic, but others develop Multisystem Inflammatory Syndrome - Children (MIS-C) which is an inflammatory response to a Covid infection which occurs 2-6 weeks after a case of Covid.  More than 60% of these children are admitted to the ICU and 1-2% of them die.  As many as 8% of children can also have mild or moderate  Covid symptoms lasting more than 12 weeks according to a UK study.  Children will receive only 10ug of vaccine instead of 30ug which the 12-15 and 16+ groups receive.  The caps on the vials for the 10ug dose, parts of the label, and all shipping boxes are bright orange.  The doses for all of the 30ug vaccine vials have purple caps and labels so no errors can be made.     See Below   

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There is a very rare incidence of myocarditis with the mRNA vaccines - mostly in 16-29 year old males. The current incidence of this side effect is 1:10,000 -1:20,000 of vaccine doses.  Myocarditis is an inflammation of heart muscle and in most cases it appears within 7 days after the 2nd dose of vaccine.  Cases have been very mild and recovery is fast - usually with no treatment or non-steroidal anti-inflammatory meds.  There are no deaths.  It is important, however to know that myocarditis also occurs with Covid-19 infection, in greater numbers and severity, so prevention of Covid infection is even more important.  There are other causes of myocarditis and most of the cases occur in males, with fewer occurring below the age of puberty.  So 5-11 year old children may have an even lower incidence than older males.  There were no cases in the clinical trial of over 3000 5-11 year old children.    

October 30, 2021

GOOD NEWS re: Pfizer Booster Efficacy

On Monday Oct 21st Pfizer had a press release about the efficacy of their 3rd dose.  They reported results from a randomized control trial -  on subjects from their Phase 3 Clinical Trial that all received 2 doses of the primary 2 dose series. More than 10, 000 volunteers from age 16 and older received 30 ug of the Pfizer BioNTech vaccine or placebo.  The median time between their second dose and the booster was 11 months.  Symptomatic covid-19 infections were assessed from at least 7 days after the booster or placebo with a median follow-up of 2.5 months.  There were 5 cases of Covid in the boosted subjects and 109 cases in the placebo group for a vaccine efficacy of 95.6%  None of the patients had evidence of a prior Covid infection. 

The age group had 55% subjects between 16 and 55 years and 23% of the subjects were were 65 and older.  They reported that after multiple subgroup analyses the efficacy was consistent across all of the age groups, sex, race, ethnicity and comorbidities.  That is excellent news for the group of 65+ subjects who all received their primary vaccination as part of the original trial and had an excellent immune response to the 3rd dose  now.  Pfizer says that the adverse event profile was the same as the original group and no safety concerns were found.  The Pfizer Press Release says that detailed results from this trial will be submitted to the FDA, European Medicines Agency and for a peer reviewed publication.  See Below  

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This very preliminary report is real world data of the efficacy of the 3rd dose at a time when the delta variant was circulating and it makes me happy to see that age didn't affect the immune response or side effects.  In September the FDA and CDC approved the Pfizer 3rd dose going forward for people over the age of 65 and for younger people with a high risk of severe infection or risks of infection because of the groups with whom they are working.  The FDA and CDC recently analyzed a clinical trial of mixing and matching the type of booster with the original vaccine type, now that Moderna and J & J vaccine booster doses were also approved.  However they suggested that it was probably best to continue with the same vaccine type unless their were significant reasons to change.     

October 27, 2021

FDA Approves Pfizer Covid Vaccine for 5-11 Year Olds

Yesterday the FDA VRBPAC Advisory Committee approved the Pfizer Covid-19 vaccine for children 5-11 years old.  At least 1.8 million children in this age group have had Covid, 8622 have been hospitalized, and 143 have died.  The Pfizer vaccine dose for adults is 30ug, and a dose of 10ug was selected for each of the two doses 3 weeks apart in these children because it gives a comparable immunity at only 1/3rd the dose.  When developing vaccines for children scientists test smaller and smaller doses until they find one that produces the same antibody response and protection against infection as an older age group.  This dose produced the same antibody levels and protection against infection as was seen with 30ug in the 16-25 year old vaccine study. 

The initial Phase 3 clinical trial had 2288 subjects which were randomized 2:1 (vaccine:placebo). This group was followed for 3.3 months and the placebo group had 16 cases of Covid-19 and the vaccinated group had only 3 for a vaccine efficacy of 91%.  In order to carefully evaluate side effects the FDA required Pfizer to double the size of the study and that group had been followed for almost 3 weeks after their 2nd dose before this report. Very rare cases of mild myocarditis has occurred in old children and adults.  This was a side effect of both of the mRNA vaccines and onset usually occurred within 7 days of vaccination and resolved quickly with non-steroidal meds.  No cases of myocarditis were seen in either group of vaccinated children - most cases are seen in males between the ages of 16 and 39 - and very rarely in younger children.   See Below  

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The side effects of vaccination in the clinical trial included mild to moderate pain, redness, and swelling at the injection site and fever, fatigue, headache and chills which were less frequent than in the 16-25 year old comparative clinical trial group.  No myocarditis or other serious adverse effects were seen.  There are several large safety systems in place to monitor side effects of all vaccine and drug clinical trials and any early warning signs are followed very closely by the FDA and CDC.  The benefit vs risk ratio is calculated for every drug or vaccine and the scientific advisory committees carefully examine all possible risks and felt that the benefits of this vaccine in 5-11 year old children far outweighs the risks.  The CDC ACIP Advisory Committee will meet Nov 2-3 and again review the vaccine data.  If approved the CDC Director then will give the final approval and vaccinations can begin.   

 

 

October 23, 2021

Booster Shots for Moderna and J and J Vaccines

Last week the FDA VRBPAC scientific advisory committee met and approved both the Moderna and Johnson & Johnson vaccine booster doses. The CDC then met this Thursday and spent the entire day listening to presentations by the companies and many CDC scientists who independently reviewed the data submitted by each company.  After a full day of analyzing and considering the efficacy and safety of the proposed booster doses, there was unanimous approval of both vaccine boosters.  Final approval was granted by Rochelle Walensky, Director of the CDC. 

The Moderna booster is one half the dose of the original two doses - 50ug instead of 100ug.  This dose had vaccine efficacy that was the same as the original vaccination dose and no increased symptoms following the injection. The booster doses were approved for the same group as the Pfizer booster: people 65 yrs or older at least 6 months after their 2nd dose, individuals 18-64 years of age at high risk of severe Covid-19, and individuals whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at higher risk of serious complications of Covid-19.  The J & J vaccine was approved as a 2nd dose, to be given more than 2 months after the initial dose for all age groups.     See Below  

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The Committee also reviewed all of the data from the NIH  "Mix and Match Vaccine Study" that was just reviewed here on my blog earlier this week, and they approved all 3 vaccines for the booster doses.   That means that each patient can select the booster dose type that they want, based on availability, or personal preference.  The Mix and Match study demonstrated that all of the heterologous and homologous booster doses produced a good immunologic response - and getting a second vaccine type was safe. 

The only way that this pandemic will be controlled is through vaccination of most of our citizens.  We are very lucky that we have very effective vaccines - please get a vaccination if you are still one of the unvaccinated.  Next week I'm looking forward to following the full day FDA meeting about the vaccine for children age 5-11.  The CDC meeting for these vaccinations is in the first week of November.

 

October 20, 2021

Booster Doses - Mix or Match

The NIH NIAID reported preliminary results from an ongoing study of mixed and matched booster doses.  There were 458 subjects in 3 primary groups.  One group was vaccinated with Moderna (2 doses), one received Pfizer (2 doses) and the 3rd one received J and J (one dose).  At least twelve weeks after their primary vaccination, and without any history of a Covid-19 infection, each of the 3 groups were further divided into 3 groups (about 50 each) and those groups each received a booster dose- either Moderna, Pfizer, or J and J.  Thus there were 9 final groups.  For example, the group vaccinated with Moderna could have been boosted with Moderna at half the original dose (homologous), or Pfizer (heterologous). or J and  J (heterologous).

See Below  

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Preliminary Results:  There was an anamnestic antibody response with all of the boosters, but the study wasn't set up to compare the antibody and neutralizing antibody titers among groups.  In addition, the cellular component of an immune response (memory B cells and T cells) is being analyzed, but is not yet complete. 

But there were no differences between the reactogenicity, local and systemic symptoms, in the heterologous vs the homologous booster doses and most were mild. Knowing that the mixing of vaccines is safe makes this a possibility moving forward.  There are many ways that this will make the booster dose easier to deliver:  patients who may have had an allergic reaction to one of the vaccines can be given one of the others.  It also will make it easier to go into a congregant care facility and boost all patients with just one vaccine type.  The FDA and CDC will now have to analyze and approve this plan to mix and match!  Stay tuned for the final approval and ongoing booster plans to be determined by the CDC and their scientific advisory committee.

  

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