Vaccin Advisors of the FDA have recommended changes to COVID vaccines

The companies that make COVID-19 vaccines must again update the shots to focus on a variant that comes closer to the tribes, a committee of independent advisers of the Food and Drug Administration unanimously recommended Thursday.

Moderna, Pfizer/Biontech and Novavax must focus on tribes related to the JN.1 Variant With their vaccines for next autumn and winter because that tension is closer to the new variants of the virus that is circulating, the advisers voted after a day -long meeting.

The recommendation came after the companies had presented data that show that vaccines offer strong protection against the latest versions of the virus, such as LP.8.1, based on viruses with regard to viruses with regard to viruses. become dominant in the US

The current Moderna and Pfizer/Biontech’s MRNA vaccines are aimed at the KP.2 tribe. The shot of Novavax focuses on a JN.1 stem.

The committee was uncertain about which specific JN.1 subvarian would be the best choice because it is not known which tribe can be dominant by the fall. The FDA will now collaborate with the companies to make a final decision, officials said.

The voice of the advisory panel is consistent with that of the World Health Organization recommendation For the next set of vaccines.

The decision underlines the state of the evolution of the virus, which has now become essentially endemic in the US and other countries. The virus continues to produce new Sub -Variants of Omicron Instead of evolving into dramatically different tribes that would pose a greater risk.

Changes in the FDA approval process

The recommendation comes two days after the FDA a New approach To Covid vaccines that would probably limit access to the shots. Although there are many questions about the new strategy, a change in tensions does not seem to make a difference in how the FDA approves the following vaccines.

The new strategy would continue the current vaccine inspection process for people aged 65 and older and younger people with health problems who give them a high risk of serious complications of the virus. Those health problems are obesity, heart disease, cancer, inactivity and other risk factors. This regulatory approach is based on information about how the immune system responds to the vaccines.

But the FDA now requires that vaccine manufacturers carry out large, expensive additional studies to evaluate the safety and effectiveness of the vaccines for children and younger healthy adults by comparing them with a harmless injection of saline. These studies would look at differences in health results, such as the development of COVID.

That is an important change compared to the current approach, which recommends and approves the vaccines for almost everyone based on the easier immune system studies.

FDA officials say that the change was inspired by the widespread immunity for the virus that people have developed due to repeated infections and vaccinations. This acquired immunity has contributed to a significant decrease in serious illness and death by COVID. The FDA estimates that 100 million to 200 million Americans are eligible for Covid vaccines under the new approach.

Some independent experts welcome the change. However, others are worried that the move would make it harder for many people who still want the vaccine to get it. That would be parents who want to vaccinate very young children and those who want to reduce their risk of mild or moderate disease, long Covid and the risk of spreading the virus to other people, such as older family members.

FDA officials say that the steps will bring the US to the approach that other countries with a high income take in the direction of the vaccines and are necessary to restore confidence in the vaccines.

Although Covid still claims more lives than the flu, most American adults have refused in recent years to vaccinate Covid and even fewer parents have chosen to vaccinate their children. Children are usually much less likely to get seriously ill from Covid, but the disease can still be serious for them, especially very young children.