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Following the suspension of the Johnson & Johnson vaccine yesterday, Dr. Joel Zinberg, a senior fellow with the Competitive Enterprise Institute who worked for 30 years at Mt. Sinai Hospital and was senior economist and general counsel at the White House Council of Economic Advisers, explains why the government agencies are being too cautious.
The Food and Drug Administration and the Centers for Disease Control and Prevention announced Tuesday that they are recommending a pause in the use of Johnson and Johnson’s COVID-19 vaccine “out of an abundance of caution.” While the action is undoubtedly well meaning, it is likely premature and counterproductive.
Out of the nearly 7 million doses of the J&J vaccine administered, 6 women suffered an unusual form of blood clot in the veins of the brain called cerebral venous sinus thrombosis (CVST), in combination with low levels of blood platelets (thrombocytopenia). One woman died and another is in critical condition. While no definite causal link between the vaccine and CVST has yet been established, it is worth noting that 62 episodes of CVST with thrombocytopenia have been reported in Europe, associated with the administration of 25 million doses of the AstraZeneca vaccine — which uses the same vaccine platform as the J&J vaccine, an adenovirus vector.
There could be a relation — or it could be a matter of chance.
CVST is reported to occur in between 5 and 15.7 cases per million people per year. At the low end of this range, we would expect to see 42 cases of CVST in the 7 million J&J vaccine recipients and 125 cases in the 25 million Astra Zeneca recipients. CVST complications may have been undercounted because they went unrecognized or unreported. Moreover, with the J&J vaccine, CVST occurred 6-13 days after vaccine administration so recently vaccinated people may have not yet manifested the complication. Nevertheless, there would have to be seven times the number of J&J cases to reach the number expected from complications.
Meanwhile the announcement has the potential to cost lives. First, it will increase vaccine hesitancy — the well-documented reluctance among many to be vaccinated because of safety concerns. This is a particular concern in minority communities. When added to the well-publicized manufacturing difficulties that ruined 15 million J&J doses, the agencies’ recommendation could cripple the vaccine’s safety reputation.
Second, it may make vaccines unavailable for hard-to-reach populations in rural and underserved areas and for patients with special needs like those who are homebound. The J&J vaccine offers major advantages over the two other authorized vaccines. It is a single dose rather than the required two doses for the Pfizer and Moderna vaccines. A single dose that is less of a time commitment and inconvenience than a two-dose regimen. It also eliminates the logistical difficulties of scheduling second doses and ensuring that they are given.
The J&J vaccine can be transported and stored for up to three months using regular refrigeration, unlike the other two vaccines which need freezers. This makes it easier to transport to rural areas and countries with less well-developed distribution systems and easier to use by small hospitals and other vaccination sites that lack specialized freezers.
Finally, the J&J vaccine is cheaper. The U.S. government purchased it for $10 per dose, while Pfizer will cost $19.50 per dose and Moderna $25 to $37 per dose. Since the latter two require two doses, the relative product cost of vaccination is $10 for J&J, $39 for Pfizer, and $50–$74 for Moderna, along with the added labor costs of administering second shots.
The acting FDA commissioner Janet Woodcock told the media that the investigation of these “extremely rare” events would move forward rapidly and could conclude within days. Why then the rush to suspend use of a vaccine because of a one in a million complication? The agencies could have alerted the medical community about the possibility of CVST and the required treatment without recommending a pause which will likely permanently undermine pubic confidence in this much needed vaccine.
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