Israel Says 4th Shot's Not The Charm
New data shows 4th dose is ineffective against infection, and symptomatic disease
On 2/15/22 a new COVID-19 vaccine study out of Israel revealed itself showing low efficacy against reinfection with Omicron, a high percentage of breakthrough infections, and large numbers of systemic and local adverse reactions after a 4th dose of either BNT162b2 30μg (Pfizer) or mRNA1273 50μg (Moderna). The results of the study will be broken down below:
Trial enrolled healthcare workers 18+ with no known history of SARS-CoV-2 infection who received their 3rd dose at least 4 months before the beginning of the study, and who had IgG antibody levels less than 700 BAU
Primary end points were safety (vaccine side effects) & immunogenicity (in-vitro neutralization of Omicron with patients serum aka blood)
Secondary endpoints were vaccine efficacy against infection and symptomatic disease
274 eligible participants were split into two arms with matched control groups
1st arm- 154 received a 4th 30μg BNT162b2 Pfizer dose
2nd arm- 120 received a 4th 50μg mRNA-1273 Moderna dose
Control arm- 426 age-matched individuals (to compare to treatment group⬆️)
BNT162b2 vaccine efficacy against Omicron infection was 30%
mRNA1273 vaccine efficacy against Omicron infection was 11%
4th dose provided an 8-fold increase of live Omicron neutralization with pseudoviruses in-vitro & 9-10-fold increase in neutralizing antibody titers within 2 weeks of vaccination, however over 30% experienced breakthrough infections/breakthrough symptomatic disease (57 Pfizer, 45 Moderna) from day 8 after the 4th dose (FIG. 3, 4a & 4b)
Local vaccine adverse reactions were reported by 80% of participants
Systemic adverse reactions were reported by 40% of participants
Follow up visits occurred on days 7, 14, and 21 after 4th dose and included safety checks + PCR test. Final follow up occurred on day 30 and used PCR or rapid test
Study failed on both primary endpoints (safety & immunogenicity) as 80% of participants reported local vaccine adverse events, and 40% reported systemic adverse events after vaccination
Study failed on both secondary endpoints as vaccine effectiveness against Omicron was 30%, and 11% from Pfizer, and Moderna respectively, while over 30% experienced some form of breakthrough infection/breakthrough symptomatic infection
What can we learn from this?
It’s quite simple, the data suggests a 4th dose against Omicron is not very effective. You see, it would be one thing if current vaccines protected against severe disease and transmission, however that is not the case with this new variant in the picture. To be specific, Omicron is much less virulent and confers substantially milder symptoms. Moreover, it spreads rapidly regardless of vaccination status. With that said, if the point of vaccination is to prevent severe disease, and transmission against the dominant variant named Omicron, Pfizer & Moderna can not do that. Regardless, we still need more data.
All and all, the CDC will have to consider adjusting its vaccine recommendations as more and more studies like this are being released on a weekly basis. Essentially, the obvious trend seems to be that 3 or 4 doses are consistently ineffective against infection.
LETS CONNECT: