Are Our COVID-19 Vaccines Safe and Effective?

Yesterday, the CDC’s HAN (Health Alert Network) issued a detailed report regarding their recommendation to pause administration of the Janssen (J&J) vaccine (see link to this report).  The CDC has now received VAERS reports from 6 women ages 18-48 of serious clotting events after the administration of 6.85 million doses of this vaccine (as of 4/12/21).  These events appear to have been triggered by the development of platelet-activating antibodies against platelet factor 4 (PF4), which is also known as heparin-PF4 antibody.  This may trigger Vaccine-induced Immune Thrombotic Thrombocytopenia (VITTP) which can have serious CNS consequences (1 death so far).  This association is quite rare at ~ 1 case per million vaccinations.  A similar problem has been seen with the AstraZeneca vaccine, which is also a viral vector vaccine (AD26), but hasn’t been seen in the USA or internationally with the Pfizer or Moderna mRNA vaccines.  The key issue for the CDC and ACIP at this point, is the possible under-reporting of this association.  Because these events occurred 6-13 days after vaccination, the development of this rare problem may not have been linked to the vaccine.  Hopefully this HAN report will bring in more VAERS reports to allow the CDC to provide more precise information on the real risk of this event in persons receiving the Janssen vaccine.  To put this preliminary risk in perspective, the known risk of “unvaccinated persons” aged 18-48 dying of SARS-CoV2 is 125/million, which is a vastly greater than the risk of acquiring (much less of dying) of VITTP.  

You are probably now receiving reports in your county of cases of “Breakthrough” COVID in fully vaccinated persons.  In Sonoma County, we have had 39 cases, none of whom have required hospitalization.  Our public health contact tracing has failed to reveal any transmission of COVID from these cases.  In MEDPAGE Today (4/14/21 - see link), an article on “Breakthrough” COVID was posted (insert link).  In Michigan, which is experiencing a fourth COVID surge, 246 fully vaccinated persons have developed COVID out of 1.8 million persons fully vaccinated.  Three of these have died.  In Oregon, there have been 168 cases among more than 700,000 vaccinated persons, resulting in 19 hospitalizations and 3 deaths.  The article had similar reports from other states and noted that these preliminary results may be over-estimates since COVID tests were not done 45 days prior to vaccination, which is required for CDC definition of breakthrough.  The CDC is still working on becoming the national repository for uniform vaccine effectiveness reporting and tracking, so we will have reliable national data.  Experts quoted in this article stated these outcomes were within the expected 90% effectiveness of the mRNA vaccines seen in their phase 3 studies.  The hospitalizations and deaths likely reflect the lower effectiveness of these vaccines in those who are immuno-compromised and at high risk for poor outcomes.

What do these reports mean for our work in LTC (Long Term Care)?  Firstly, the CDC should be lauded for placing a pause on the administration of the Janssen vaccine.  This supports our messaging that these vaccines will only be used if they are safe.  Secondly, our understanding the “real-world” effectiveness of these vaccines is still evolving.  To a large extent, their effectiveness will be related to the prevalence of COVID-19 in the community and the predominance of aggressive variants.  

In the interim, it’s clear that we will need to continue following CMS, CDC, CDPH, and CDSS public health guidance regarding testing for COVID (even in fully vaccinated HCWs) and the use of masks and social distancing.  In the indoor spaces, the public should be double masking (medical mask covered with cloth mask to improve the facial seal).  For fully vaccinated seniors, though indoor dining is an option now, this option ideally should be deferred until there is dining only for the fully vaccinated or until the community prevalence of COVID is much less. 

The message to our residents, staff, and visitors at this time should be that everyone who doesn’t have a contraindication should have a vaccine when it becomes available to them.  The sooner we reach herd immunity, the less likely we will see new aggressive variants or more “Breakthrough” COVID cases, particularly in those who have immune-senescence and immuno-compromised states.  

I look forward to the day when I can again safely travel to see my grandkids and can attend indoor dining and “live” indoor music performances.

MEDPAGE Today article:

NEJM article:

Share this post:

Comments on "Are Our COVID-19 Vaccines Safe and Effective?"

Comments 0-5 of 0

Please login to comment