" Times, however, have changed. The respected and conservative Wall Street Journal ( WSJ ) has aired concerns about poor regulatory decisions at the US Food and Drug Agency (FDA) over booster shots. It joins a growing international chorus of highly qualified and influential voices.
On April 3, in an opinion piece entitled ‘FDA Shuts Out Its Own Experts in Authorising Another Vaccine Booster’,Dr Marty Makary, a surgeon and public policy researcher at Johns Hopkins University School of Medicine, wrote: ‘The FDA last week authorised Americans over 50 to get a fourth Covid vaccine dose. Some of the FDA’s own experts disagreed, but the agency simply ignored them.’
Eric Rubin, editor-in-chief of the New England Journal of Medicine (arguably the world’s most influential medical journal) and a member of the FDA advisory committee on vaccines told CNN last month: ‘I haven’t seen enough data to determine whether anyone needs a fourth dose.’
Dr Cody Meissner, also a member of the FDA vaccine advisory committee and chief of paediatric infectious diseases at Tufts Children’s Hospital in Boston, agreed: ‘The fourth dose is an unanswered question for people with a normal immune system.’
A third member of the committee, Dr Paul Offit of the Children’s Hospital of Philadelphia, went further. He told the Atlantic magazine that he advised his 20-something son to forgo the first booster.
Two top FDA officials, Marion Gruber, Director of the FDA Office of Vaccine Research and Review and her deputy Paul Krause, quit the FDA in September last year complaining of undue pressure to authorise boosters and a lack of data to support their use.
Unbelievably, the US Centers for Disease Control (CDC) rubber-stamped the FDA decision to approve a second booster without even convening its panel of external independent vaccine experts.
The WSJ article described the effect of boosters as fleeting, mild and short-lived. It sounded a note of alarm saying that neither the CDC nor the US National Institutes of Health (NIH) had made a priority of studying vaccine complications. Moreover their VAERS data collection and analysis process is incomplete and inadequate. In other words, the safety investigation to date of adverse effects of mRNA vaccination is incomplete and potentially misleading.
The central question raised by the WSJ opinion piece is, why wouldn’t the US regulators wish to undertake accurate and complete investigation of adverse effects of mRNA vaccination? Have pharmaceutical interests been able to influence decision-making at the FDA to their own commercial advantage at the expense of safety considerations?
The British Medical Journal agrees. On March 16 it published an article which said: ‘Evidence-based medicine has been corrupted by corporate interests, failed regulation and commercialisation of academia.’
The lessons are obvious. We have stifled debate and slavishly followed FDA advice. Now there is a need for revaluation and debate. We have travelled a long way down a one-way street, but it appears to be a dead end. The triumphant articles published about a survey of vaccine-resistant people born in Dunedin was a low point in uncritical mainstream media publishing. We have to regain an objective voice.
A paper published on April 5 in the New England Journal of Medicine found that any measurable protective effect of the fourth inoculation (which in any case, it found, is very small in absolute terms) disappeared after just eight weeks. Moreover a paper in the Lancet on April 8 admitted that boosters carry a risk of additional side-effects. Both these papers, however, skirted the obvious safety questions in favour of weak praise for vaccine orthodoxy.
In contrast the WSJ article asked the important question: ‘Who is actually getting serious about measuring the extent of adverse events, rather than continuing to urge uncritical acceptance of a largely ineffective vaccine?’