The FDA approves the updated Covid Pfizer shots but limits access to certain children and adults

Washington – American regulators approved COVVI-19 shots from COVVI-19 on Wednesday, but limited their use for many Americans-and have removed one of the two vaccines available for young children.

The new plans of Pfizer, Moderna and Novavax are approved for all the elders. But Food and Drug Administration has reduced their use for young adults and children to those who have at least one state of high -risk health, such as asthma or obesity. This has new obstacles to access to millions of Americans who should prove their risk – and millions of others who may want to be vaccgled and no longer eligible.

In addition, the PFIZER vaccine will no longer be available for a minor child 5, after the FDA said that it revoked the emergency authorization for this age group.

Parents will always be able to look for fire from Rival Moderna prudence, the other manufacturer of mRNA vaccines, which has complete FDA approval for children as young as 6 months. But the company’s spikevax vaccine is only approved for children with at least a serious health problem.

Recorded vaccines target a more recent version of the virus constantly evolving and should start to ship immediately. But there may be days or weeks before many Americans know if they can get one, access depending on various decisions by healthy health advisers, private health insurers, pharmacies and state authorities.

The new restrictions – previewed by FDA officials in May – are a break from the previous American policy, which recommended an annual COVVI -19 annual shot for all Americans of 6 months and more.

The approach reflects increased skepticism with regard to the risks during COVID-19 and the need for annual booster blows from the Health Secretary Robert F. Kennedy Jr. and the FDA commissioner, Marty Makary, who were both critical of large-scale vaccinations.

“The American people demanded science, security and common sense. This framework delivers the three,” wrote Kennedy on social networks.

Kenned said that Novavax shooting is only open to people aged 12 or over, not younger children – and under the same restrictions based on risks as those who are now in place for Moderna and Pfizer options. It is the only COVVI-19 vaccine based on protein in the country.

Some medical groups, including the American Academy of Pediatrics, have opposed new limits, saying that they can block access to vaccines for families who wish to protect their children. Last week, the group offered its own recommendations for children, saying that annual shots are highly recommended for children from 6 months to 2 years old and advised for older children.

This differs from the latest advice under Kennedy, who does not recommend blows for healthy children of all ages, but says that children can get the blows in consultation with doctors.

Many countries have reduced COVVI-19 vaccinations in recent years, and some American experts say that change has meaning here, since almost all Americans have some protection against vaccination or previous infection.

But the implementation of the quarter has a number of logistical problems.

Insurers generally base their vaccine coverage decisions on the recommendations of a panel of Centers for Disease Control and Prevention, but some say they will also turn to medical medical groups, including the American Medical Association.

Earlier this year, Kennedy dissolved the CDC panel and replaced its members with a number of doctors and researchers who have repeatedly presented the safety of vaccine and commonly used ingredients. The panel should meet in September, but no specific date has been set and no agenda has been published.

According to the advice of the panel, we could expect the miners 65 to provide the documentation for a serious medical condition before we can get a shot. Deployment is the fact that pharmacists – who administer most of the vaccines covid in the United States – are generally not supposed to collect this type of information. And the laws governing their ability to administer routine vaccinations vary depending on the state, where pharmacists are authorized.

Almost half of states limit vaccinations by pharmacists to those recommended by the CDC panel.

Access could also be complicated for healthy adults and children who wish to get a shot for additional protection.

If the latest vaccines are not covered by their insurance, these patients may be required to pay $ 150 or more from their pockets if they want one. They may also have to find a doctor or other healthcare professional ready to give the blow “out of the label” or outside the use listed on the FDA label. Pharmacists can be reluctant to give vaccines out of AMM.

The updated plans of Pfizer, Moderna and Novavax target a coronavirus subtype named LP. 8.1, a recently dominant version of the virus which is closely linked to certain newly emerging cousins.

The three plans were initially made available under the Emergency Use authorization of the FDA, an accelerated process to quickly examine vaccines and other countermeasures during the pandemic.

Moderna received the FDA full approval in July for children at 6 months old and says it should have enough supply to meet American demand.

In addition to revoking the emergency use of the PFIZER vaccine, the FDA has also drawn permission from several other therapies for pandemic years, including convalescence plasma, which was used to treat COVVI-19 hospitalized patients before the first antiviral drugs become available.

COVVI-19 vaccines are doing a good job to prevent serious illnesses, hospitalization and death, which remain a greater risk for the elderly and people with underlying health factors, including heart disease, pulmonary diseases and cancer.

The CDC preliminary data estimate that 47,500 Americans died of causes linked to COVID last year. In at least two thirds of these cases, COVID-19 was listed as the underlying cause of death. For the rest, COVID-19 was a contributing factor.

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The medical writer AP Lauran Neergaard contributed to this story.

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