Safety of mRNA Vaccine vs Flu and other Vaccines, Novavax Vaccine

Last week the new bivalent mRNA boosters were reviewed.  Key points were:

• Booster mRNA bivalent vaccines for Covid were approved by the FDA under emergency use authorization.
• There were no human clinic trials done for the bivalent vaccines for the first time in vaccine history
• “Totality of Evidence” used for FDA approval was:
  • 8 mice tested for Covid antibody titers after the vaccine with varied results
  • 10/10 mice tested positive for Covid in the nose and lungs after Covid exposure following the booster.
• There is no efficacy data.

This week’s blog is about safety of the mRNA vaccines as the bivalent booster is using mRNA vaccine technology similar to the original mRNA vaccine.  Also discussed is Novavax Vaccine for Covid and a comparison of flu vaccines versus mRNA vaccines.

Safety Data of Original mRNA Vaccines

In a previous blog post reviewing the court ordered vaccine data released by Pfizer, these being Pfizer’s internal clinical trials, the following were found:

• The adverse event rate per dose came out to be nearly 1 in 800.
• Pfizer hired an unprecedented number of additional employees to manage the large number of adverse events.
• They stated, “The effects of the COVID-19 vaccine on sperm, a pregnancy, a fetus, or a nursing child are not known.” These effects are still unknown.
• Vaccine-associated enhanced disease or a predisposition to a more severe disease due to the vaccine was not yet ruled out. This is still an undetermined effect.
• Myocarditis risk was higher than previously reported and subclinical myocarditis and long-term sequelae following the vaccine were unknown and remain unknown. The FDA included the same myocarditis warning for the updated boosters in their press release.

The following is a summary of reported COVID vaccine adverse events in the United States from OpenVAERS.

It is well established there is underreporting of adverse events on the Vaccine Adverse Event Reporting System (VAERS). A Harvard study determined less than 1% of vaccine adverse events are reported. 

A recently published study assessing serious adverse events following mRNA COVID vaccines revealed a higher risk of such events for both the Pfizer and Moderna adult phase 3 trials compared to placebo.

The study reports the Pfizer trial exhibited a 36% higher risk of serious events and a 6% higher risk for the Moderna vaccine. The authors conclude the excess risk of serious adverse events warrant a formal harm-benefit analysis of the mRNA vaccines.  

The World Council for Health recently published a pharmacovigilance report assessing if a safety signal for the mRNA vaccines is present. They reviewed data from official government databases across the world: VAERS, WHO VigiAccess, EudraVigilance and UK Yellow Card for Covid-19 vaccines.

The World Council for Health report the adverse events linked to the Covid-19 vaccines are between 10 and 169 times more than events observed in other commonly administered vaccines. 

“The Polio Vaccine was recalled in less than 1 year after 10 reported deaths,

 the Swine Flu Vaccine was recalled in less than 1 year after 53 reported deaths. 

The Covid-19 vaccine, with over 28,000 associated reports of death, has not been recalled.”

The study concluded, adverse events from Covid-19 vaccine are serious in nature, and sufficient evidence in all databases examined establish a concerning safety signal warranting an immediate product recall.   

The following graphs put in perspective risk of death and adverse events from Covid-19 vaccines compared to flu and other vaccines.

Can we compare mRNA boosters to Seasonal Influenza Vaccines? 

Data from influenza vaccines has been acquired over the past 50 years. The first inactivated influenza vaccine was licensed for use in 1945. Live attenuated vaccines have been approved since 2003. Each year, experts look at the data to determine which strain of influenza will be dominant. Flu vaccines contain the live or attenuated virus and are not comparable to mRNA vaccines.

However, all vaccines follow the “Original antigenic sin” meaning the more you vaccinate, the lower protection against new strains.  Every year the flu vaccine becomes less and less effective.  CDC data shows 56-60% effectiveness in 2009 to 2011.   2018 to 2022 showed a 29-35% effectiveness.  No effectiveness was recorded in 2020-2021 stating there was not enough data to compute.    https://www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm

A June 2022 study closely followed triple vaccinated healthcare workers with or without prior infection showed those:

• who were initially infected with the original Wuhan-1 strain, were then triple vaccinated, then became infected by omicron, mounted no immune response against omicron.  Participants immune fighting T cells had no recognition of the virus.
• who had no prior history of Covid infection, were then triple vaccinated, became infected with omicron, mounted a dampened immune response. 

The authors conclude this agrees with other observations mRNA vaccinations against the omicron variant “offers no protective advantage.”  This conclusion validates “original antigenic sin” and imprinting.

Experts have conflicting opinions on comparing the updated mRNA shots to the annual flu shots. Head of the FDA, Peter Marks MD, stated, “We’re pretty confident that or what we have is very similar to the situation that we’ve done in the past with influenza changes where we don’t do clinical studies for them in the United States.”  Member of the FDA’s Vaccines and Related Biological Products Advisory Committee, Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, Paul Offit MD, who voted against authorization of the bivalent boosters “believes the comparison between flu shots and COVID-19 shots is not well grounded due to the differences in mutations and protection levels.”

Novavax, An Alternative Vaccine to mRNA Vaccines for Covid

You don’t hear much about Novavax in the media.  Novavax is a protein-based vaccine, one of the “old school” types. Trials were conducted before delta and omicron variants were done during a 90% alpha predominant time period.  As we now know, efficacy of the mRNA vaccines was lower with newer variants and waning effectiveness. The efficacy from the Novavax trials was approximately 90%.  The efficacy period was approximately 3 months and there is currently no data on waning effectiveness.

Trial subjects were followed for safety for a median of 2 months. Long term safety is planned to continue through 24 months after initial vaccination. Side effects were reported to be mild but there was an increase in systemic reactions after the second dose.

Cases of myocarditis and blood clots were identified following vaccination. Novavax must carry a warning for pericarditis and myocarditis like the mRNA vaccines. There were 4 out of 30,000 study participants who developed heart inflammation within 20 days of vaccination. There were 6 cases of blood clots classified as serious. The EU Agency identified severe allergic reaction as a side effect.

As it is not a genetic vaccine, the Novavax spike protein vaccine is better controlled than the mRNA vaccines and will still last long term within the body.  Novavax is thought to be safer than the mRNA vaccines though we are still missing long term safety, effectiveness against new variants, and waning effectiveness.

Last month, Novavax submitted a request to the FDA to be approved as a booster.  Novavax states, “If authorized, the Novavax COVID-19 Vaccine, Adjuvant could be used as a booster dose for adults aged 18 and older vaccinated with any other currently available COVID-19 vaccine.” The effects of interchanging vaccine products have not been studied.

Questions posted in last blog we still do not have answers to in regards to mRNA bivalent boosters:

• How will the bivalent boosters perform in humans?
• Are the updated bivalent boosters safe?
• Are the updated boosters effective?
• What are the long-term safety effects of the original mRNAvaccines?
• How long will protection last if it is effective?
• How long will omicron be the dominant strain?
• Will there be a new variant, making these boosters obsolete?
• Why is the FDA approving the boosters under emergency authorization?
• What is the emergency?  
• According to the CDC’s COVID Data Tracker, cases, deaths and hospitalizations are trending down

Current data for the updated bivalent boosters is minimal. Important questions remain regarding safety and real-world efficacy. Human trials have not yet begun to assess these questions.

Obtaining transparent information is critical when considering benefits and risks of any treatment.  Current data shows the risk of hospitalization, ICU admittance and death with variants BA.4/5 is low.  Currently, no one knows the benefit of the mRNA bivalent boosters to determine a risk/benefit analysis.

Novavax may be a safer booster than mRNA boosters when available. Conventional vaccines carry a lower risk of adverse events than mRNA vaccines.

Have an awesome day!  Dr D