FDA announces fifth COVID-19 dose may be necessary by Fall, just hours after authorizing fourth shot

04/04/2022 / By Mary Villareal

Just hours after the Food and Drug Administration (FDA) authorized a fourth shot of the Moderna and Pfizer Wuhan coronavirus (COVID-19) vaccines, the agency’s website said a fifth shot may be necessary by fall.

Dr. Peter Marks, head of the FDA center that regulates these vaccines, told reporters on a call that there may be a need to get an additional booster in the fall, as well as a more general booster campaign, especially if there is a need to shift over to a different variant coverage.

The recently announced emergency use authorization is for the fourth shot for Americans ages 50 and above and for children as young as 12 with weakened immune systems. These boosters from Pfizer and Moderna specifically target the strains circulating in early 2021, but multiple strains have since emerged and become dominant in the United States.

Moderna and Pfizer are not testing vaccine formulations that specifically target omicron. The Office for National Statistics in the U.K. has previously noted that the risk of being reinfected by the omicron variant was around 10 times greater compared to the delta strain.

Marks said they will move to a vaccine that is either against one of the variants or something else, but that’s still up for discussion. However, he did state that it is possible that people will need another vaccine.

The FDA was also said to authorize the outdated boosters because regulators felt that doing so could save lives and because it may take several more months to figure out if an omicron-specific booster works. Moreover, it is not actually clear yet what the optimal booster will be, according to Marks. (Related: NEEDLES FOREVER: United Kingdom’s NHS launches FIFTH COVID jab.)

The matter regarding more vaccine shots will be discussed on April 6 with the FDA’s expert advisory committee.

Some have raised concerns about repeatedly injecting people with the COVID-19 vaccines, partly because the main vaccines were developed using mRNA technology, which has never been cleared before the use of the pandemic. Others, on the other hand, believe the vaccines are better taken at less frequent intervals, although multiple studies have shown that the vaccines’ effectiveness drops in a matter of months.

Repeated boosters could pose problems with immune responses

If boosters are administered repeatedly, there could be potential problems with immune responses.

Marco Cavaleri, head of vaccines strategy of the European Medicines Agency, said vaccinated individuals’ immune responses may end up not being as good as authorities would like them to be, so people should be careful not to overload their immune systems with repeated immunization.

Dr. Robert Malone, who had input in the mRNA technology also said in the research he’s reviewed, the vaccines were shown to lead to immune suppression, where the body’s natural immune system is weakened against all kinds of infections and diseases. “This is the risk associated with this strategy of reboosting,” he said.

When presented with Marks’ remarks, he said they were unfounded and are pure speculation. “That’s a forward-looking statement. There’s no scientific basis for evaluating it. And it’s inappropriate for the FDA to be speculating like that, in my opinion.” (Related: White House seeks more funding for COVID vaccine boosters – but Republicans say NO.)

WHO expects COVID-19 to be less severe over time

The World Health Organization expects COVID-19 to be less severe over time, with a report setting out how countries should react to worst-case, best-case and intermediate-case of the pandemic.

Tedros Adhanom Ghebreyesus, WHO’s director-general, said at a press briefing: “Based on what we know now, the most likely scenario is that the COVID-19 virus continues to evolve, but the severity of the disease it causes reduces over time as immunity increases due to vaccination and infection.”

The emergence of the omicron variant made people more optimistic that the COVID virus was evolving into a more transmissible but less dangerous illness, but this is not always the case for virus evolution.

However, COVID-19 immunity, whether naturally acquired or via vaccines, does tend to wane over time and leave people more prone to reinfection – with omicron evolving to better evade immunity with a higher reinfection rate compared to other variants.

Follow Vaccines.news for more updates regarding COVID-19 vaccines and mandates.

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