EXCLUSIVE: Stanley Plotkin on the lack of vaccine-safety science
The ‘godfather’ of vaccines responds to his provocative editorial about the lack of vaccine safety studies.
Stanley Plotkin, often referred to as the ‘godfather’ of vaccines, recently coauthored a provocative editorial in the New England Journal of Medicine, admitting that the monitoring of vaccine safety is ‘inadequate.’
Plotkin and his co-authors say they are concerned about the growing distrust of vaccines, fuelled by “the widespread vaccine hesitancy observed during the Covid-19 pandemic.”
The editorial explains that phase III clinical trials are not large enough to detect “rare” adverse events, so regulators have to rely on post-marketing surveillance to find safety signals.
But post-marketing surveillance is inadequate and safety studies to determine if adverse events are ‘causally’ or ‘coincidentally’ related to a vaccine, are lacking.
Further, a table in the editorial shows the ‘biological mechanism’ for most vaccine injuries is not understood -- from the 1976 Swine flu vaccine to the 1988 Rotavirus vaccine to the current day covid-19 vaccines.
Understanding the biological mechanism of vaccine injuries not only enables the development of safer vaccines, but it also informs which injuries meet the requirements for compensation on the US Vaccine Injury Compensation Program (VICP).
Plotkin and his co-authors propose a solution.
They suggest that funding for vaccine-safety research could come from the same pot of money that has been earmarked for compensating people with vaccine injuries, i.e. the VICP fund.
They argue that because the VICP fund is in surplus, then “using this balance for vaccine- safety science and reduction of vaccine reactions would benefit immunization programs and the public, in keeping with the VICP’s intent.”
As of April 2023, the remaining balance was $4.3 billion, but critics say this money should not be taken from the VICP fund to conduct vaccine safety studies that should have already been done.
At 92, Plotkin is still considered a giant in the vaccine industry.
I reached out to Plotkin after his editorial was published -- he denied my request for a recorded interview because he believed that I was “an opponent of vaccines.”
I challenged that characterisation of me, and he agreed to answer written questions.
Here, Dr Plotkin responds to concerns about vaccine safety, the crowded childhood vaccination schedule and whether manufacturers should be liable for vaccine injuries.
