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FDA Set to Approve COVID Vaccine Booster Shots for Certain People

AP Photo/Mark Lennihan, Pool

The Food and Drug Administration will authorize a third dose of both the Pfizer and Moderna COVID-19 vaccines as a precaution during the surge of positive tests due to the Delta variant.

The booster shot will be authorized for those with compromised immune systems only. This is a relatively small number of people — transplant patients and those with some auto-immune disorders. But the trend in thinking about the efficacy of vaccines over time is greatly concerning to the FDA and the odds are good that the agency will recommend that most people inoculated with either the Moderna or Pfizer vaccine receive a third dose before the winter months keep most Americans inside.

Several countries have already begun to give their most vulnerable citizens booster shots. The policy is controversial because most of the world has yet to receive a single dose of the vaccine. But it shouldn’t surprise anyone — except the dunderheads at WHO — that nations that can afford to vaccinate their citizens will make sure they get whatever they need to keep them alive.

Politico:

The FDA’s decision does not allow for extra doses of vaccine to be given to immunocompromised people who originally received Johnson & Johnson’s one-dose Covid-19 shot — primarily because officials believe that very few immunocompromised people got that vaccine. Federal regulators authorized the J&J vaccine well after the immunocompromised population got access to Covid-19 vaccines, and the CDC has long recommended that those people specifically seek out Pfizer or Moderna’s shots.

Biden administration officials and medical experts have long expected that high-risk groups, including immunocompromised and elderly people, would need additional doses of Covid-19 vaccines to maintain protection from infection. Federal officials have sought to emphasize in recent weeks that additional doses for these groups would be different than giving booster doses to the general public. It is not clear yet that healthy adults and teenagers will need booster shots.

The government has been studying the booster shot issue since before the FDA authorized emergency use of the vaccines. Only time will tell researchers how long the vaccines will be effective and whether they will maintain their potency against the new COVID variants. To date, the jury is still out on how effective the Moderna and Pfizer vaccines remain. There is some indication of a falloff in antibodies — a sign that the vaccine’s immunity may have a limited shelf life. But so far, “breakthrough” infections remain relatively rare — despite the hysteria from the news media.

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There has been some discussion about allowing those who were administered the Johnson & Johnson COVID vaccine to gain access to a booster shot. The FDA may decide at its meeting on Friday to allow it.

Meanwhile, the pharma companies have never stopped conducting clinical trials. They have conducted research into whether it’s safe to mix the two vaccines so that those with only one shot can get another from a different company. They have continued to look at the efficacy of their vaccines. And they are racing to conclude human trials involving those under 12 years old. For those parents who decide their child can be vaccinated, the FDA will probably approve both vaccines in the next two months.

While there is much-unwarranted media hysteria over the Delta variant, we are still in the early stages of understanding the coronavirus and its effects on the human body. For those of us vulnerable to serious disease, all the information we can get about treatments and drugs is necessary to make an informed decision going forward.