FDA to restrict future COVID-19 shots to the elderly and people with serious infection

The US Food and Drug Administration changes the way they are approved by COVID-19-vaccines for Americans-a step that will restrict future vaccines to older Americans and people with a higher risk of serious COVID-19 infection.

The agency changes the standard of evidence that is required to approved COVID-19 vaccines in the USA

The change means that COVID-19 shots will probably be available for adults aged 65 and over in autumn, and those with underlying conditions that you may have exposed to a higher risk of a covid-19 infection, but not for everyone who was previously justified for an updated shot. Almost three quarters of the Americans from 6 months and older are a higher risk, according to the US centers for the control and prevention of diseases.

The change that has already been examined by experts who advise the CDC about its vaccine recommendations will make the United States closer to Great Britain, Canada and Australia with covid 19 vaccine recommendations.

According to the new criteria, millions of healthy adults and children will probably lose access to updated vaccines. Prasad and Makary say that there is not enough evidence that healthy children and adults of regular covid 19 shots make a clinical sense. You want to see placebo -controlled studies, especially for adults aged 50 to 64, before you recommend the recordings for other groups.

Dr. Noel Brewer, professor of public health and health behavior at the University of North Carolina in Chapel Hill, said he supported the change.

“The proposed politics is in line with other countries. This global view of public health is a welcome development,” said Brewer, who stands for vaccination practices in the CDC consulting committee and was part of the working group

But he and other experts say that they are still concerned about the youngest children who have under 2 years, the high hospital rate of Covid-19.

Dr. Paul Offit, director of the Vaccine Education Center in the children’s hospital in Philadelphia and a member of the independent advisory group of the FDA for vaccines, says that he did not agree with the underlying premise of the new framework.

“We used an evidence-based approach for the COVID-19 vaccination, but you are, so to speak, and believe that for the first time we received” Gold Standard “data, robust data for the first time, because we don’t have it after you, but we have that,” said Offit.

“That is why we made good decisions about the vaccine. That is why this vaccine is remarkably certain. I think the mRNA vaccines are remarkably safe.”

The editorial says that COVID-19-vaccines for people aged 65 and over 6 months and older health states, which they are exposed to with a higher risk from Covid-19 infections, are approved after pharmaceutical companies can prove that they can create protective antibody concentrations in humans.

These types of studies are referred to as immunobridging studies. As a rule, they are carried out with a lower number of people, and above all, they can be carried out quickly so that the production of vaccines can be increased in good time in order to prepare a large number of shots for an expected wave of illness, usually in autumn and winter.

In this way, the seasonal flu vaccinations are approved every year in the USA, and the way the FDA approved Covid 19 vaccines in recent years.

For all others, the FDA only approves vaccines after studies that prove that the recordings are symptomatic of Covid-19 better than a placebo. The FDA will also take several secondary results into account, including serious illnesses, hospital stays and death.

The new plan does not take any other effects of COVID-19 infections such as Long Covid. Studies have shown that vaccination can reduce the risk of developing a long covid by 25 %and 60 %.

Prasad and Makary say that the new politicians quickly approve vaccines in order to make them ready for the most endangered adults and children in the fall, with the need to prove more before they offer them to others.

In addition, they say that millions of Americans under the age of 65 continue to be qualified for a COVID 19 vaccine if they want one if they have a wide range of health states that are exposed to a serious disease of Covid-19 as one person.

“It is estimated that 100 to 200 million Americans will have access to vaccines in this way,” the FDA officers wrote.

Prasad and Makary say that their goal of requiring more evidence for other groups is to restore public trust in vaccines.

They point out that less than 25% of the Americans have received a Covid 199 shot in the last two seasons, including less than 10% of children and less than 50% of adults over the age of 75.

They say that the recommendations and mandates of Covid-19 vaccines during Pandemic public trust and the falling rates for other types of vaccines such as measles, mumps and rubella vaccines caused.

This is a message and is updated.