The FDA’s New Vaccine Strategy

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STORY AT-A-GLANCE

  • When the bivalent COVID boosters against Omicron first came out, only those who had received the initial series of shots were eligible to receive them, but uptake was disappointing. Less than 5% of those eligible had taken a bivalent booster by October 2022, and by late January 2023, that had only risen to 16.2%
  • In the hopes of increasing uptake of the jab, the U.S. Food and Drug Administration is now recommending everyone get an annual COVID shot, even if you didn’t receive the initial series
  • Under the new approach, most people will be advised to get whatever the latest version of the COVID shot is, once a year, just like the flu vaccine. And, as with the flu vaccine, the FDA’s advisory committee will meet each June to determine which SARS-CoV-2 strains should be included in the shot given that fall
  • Should a particularly dangerous strain emerge, the FDA will roll out an additional emergency jab directed specifically at that strain. Such an emergency dose would then be given in addition to the annual shot
  • As with the annual flu vaccine, the FDA is not requiring reformulated mRNA shots to undergo additional testing. Reformulations are deemed “safe and effective” based on the original shots. The problem is that the Centers for Disease Control and Prevention has hid and is ignoring hundreds of safety signals found in its post-market data

The FDA’s Latest Vaccine Strategy

When the bivalent COVID boosters against Omicron first came out, only those who had received the initial series of shots were eligible to receive them. Uptake was disappointing, to say the least. The initial U.S. estimate ended up being off by a whopping 95%, as less than 5% of those eligible had taken it by October 2022.2

As of late January 2023, more than 73% of the U.S. population (aged 5 and older) were eligible, having received the primary series, but only 16.2% had received the updated bivalent booster.3 In the hopes of increasing uptake of the jab, the U.S. Food and Drug Administration has devised a new strategy — an annual COVID shot that doesn’t require having the initial series.4,5

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) met January 26, 2023, to discuss the plan.6 Background materials7 detailing the new strategy were published January 23. As has become the norm, the proposal passed without significant deliberation about the risks.

Under the new approach, most people will simply be advised to get whatever the latest version of the COVID shot is, once a year, just like the flu vaccine. And, as with the flu vaccine, the VRBPAC will meet each June to determine which SARS-CoV-2 strains should be included in the shot given that fall. While a single dose will be the norm for most, the very young, the very old and those with compromised immune systems will be advised to get two doses.

Preconditioning You to Accept ‘Emergency’ Doses

That said, should a particularly dangerous strain emerge, the FDA will roll out an additional emergency jab directed specifically at that strain. Such an emergency dose would then be given in addition to the annual shot.

This, I would say, is a clever way of…

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