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2022-04-12| COVID-19

Good or Bad: The 4th Dose of mRNA COVID Vaccine

by Eduardo Longoria
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The European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF) have concluded that it is too early to consider using the fourth dose of mRNA COVID-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax) in the general population.

Related article: The Absence of Long COVID Treatment Plans Has Become a New Business Opportunity for Medium-sized Pharmas

Safety Concerns of the Fourth COVID Vaccines

 

There is evidence for the lack of safety concerns around the administration of a second booster shot(fourth dose); primarily coming from Israel. This data indicates that a second booster given at least 4 months after the first booster restores antibody levels without raising any new safety concerns. Data also suggest that a second booster provides additional protection against severe disease, although the duration of the benefits is not yet known and the evidence is still limited.

 

EU: Appear No Benefits from the Fourth Dose

 

As of the end of March 2022, 83% of adults had received full initial vaccinations and 64% had received a booster dose. Given this information and the data gathered in Israel, both agencies agreed that a fourth dose can be given to adults 80 years of age. While this is true that adults under 60 with normal immune systems do not appear to have any benefit from a fourth dose. 

 

Australia Has Approved the Fourth Vaccine Dose

 

Outside of Europe, both Australia and the US have some controversy surrounding the fourth dose of the vaccine. The primary question that both countries are trying to answer is whether or not the vaccine must prevent infection entirely or simply prevent severe infections. In the case of severe infection, both countries find that the vaccine’s efficacy is being maintained and a fourth dose is unnecessary. However, from the perspective of preventing infection entirely, the vaccine is losing efficacy and a booster shot could be warranted. 

Australia has approved the fourth vaccine dose but recommends waiting four months after COVID-19 infection before receiving this booster.

At the moment, ATAGI (Australian Technical Advisory Group on Immunization) says there’s “insufficient evidence of the benefits of an additional booster dose” and “Protection against infection wanes after the first booster dose…”

 

USA FDA: A Booster Mania?

 

Meanwhile, US authorities are skeptical of the need for a booster as well as the motives of some companies. In particular, Stephane Bancel, CEO of Moderna had already told Goldmann Sachs about the need for fourth doses in the fall to compensate for the natural waning of the antibodies’ presence in people who took the vaccine. This comes along with Pfizer CEO Albert Bourla telling CNBC, before the company even filed its request with the FDA, that there’s a need for a fourth dose despite saying that regulators would ultimately come to their own conclusion.

Despite skepticism the FDA authorized a second booster shot for people aged 50 and older in late March, and the Centers for Disease Control and Prevention quickly backed their distribution hours later.

“I just think it’s sort of booster mania. I think the companies are frankly acting like public health agencies,” said Dr. Paul Offit, vaccine expert and member of the FDA committee.   

The data that contradicts Dr. Offit and was used to back the approval of a 4th dose is the aforementioned data from Israel that was referenced by both Europe and Australia. Israel acts as a good reference because it rolled out its fourth doses months ago. 

Across countries in the developed world, the zeitgeist breeds skepticism as regards the response to this pandemic. As infection rates slow and most people are vaccinated there is time to think about policy and the role of pharmaceutical firms in shaping that policy. Irrespective of what side of the discussion you are on, this pandemic has affected the way that many people see medicine and how it is provided. 

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