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FDA Set to Approve Pfizer Vaccine for Youth by Early Next Week

Washington — Food and Drug Administration Pfizer-BioNTech Corona Virus Vaccine By early next week, adolescents between the ages of 12 and 15 have opened a US vaccination campaign to millions of people, according to federal officials familiar with the agency’s plans.

Some parents have been counting weeks since then Pfizer Announces Results of Adolescent Trial It shows that the vaccine is as effective as adults, at least in that age group. Vaccination of children raises the immunity level of the population, Number of hospitalizations and deaths..

Authorization in the form of an amendment to an existing emergency use authorization for the Pfizer vaccine may come as early as this week. If so, the Centers for Disease Control and Prevention’s Vaccine Advisory Board may meet the next day to review clinical trial data and make recommendations for vaccine use in adolescence.

This expansion is a major development in the national vaccination campaign and is welcome news for some parents who are anxious to protect their children during summer activities and before the start of the next school year.It also poses another challenge for policy makers who are struggling to vaccinate the majority of adults. Hesitate to take a shot.. More people may refuse to inoculate their children.

Pfizer reported A few weeks ago, a young man in a clinical trial who was vaccinated was found not to develop a symptomatological infection. According to the company, volunteers showed a strong antibody response and experienced almost the same side effects seen in people between the ages of 16 and 25.

Stephanie Kakomo, a spokesman for the Food and Drug Administration, said he couldn’t comment on the timing of the authorities’ decision.

“We can assure the public that we are working to consider this request as quickly and transparently as possible,” she said.

Over 100 million adults in the United States Completely vaccinated.. However, approval will arrive in the midst of delicate and complex propulsion to reach 44% of adults who have not yet received a single shot.

Much of the world Surplus of US-made vaccineThe use of Pfizer-BioNTech Shots in adolescence also raises the question of whether the supply should be targeted at age groups that seem to be largely immune to the serious Covid-19 so far.

“If there are not enough vaccines in the world to protect high-risk adults from death, there is a need to discuss national and global ethics for children vaccinated with a low risk of serious viral complications. I think there is, “said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health and Security.

President Biden came down Increased pressure To provide part of the national vaccine supply. Some federal authorities have also urged governments to quickly determine the amount of vaccine needed so that the dose does not expire or be shipped to the state and become unused. The federal government has purchased 700 million doses of three federally licensed vaccines to be delivered by the end of July. This far exceeds the amount needed to cover all Americans.

White House officials said last week it was going to make AstraZeneca vaccine can be given up to 60 million times To other countries as long as federal regulators consider the dose safe. The vaccine has not yet been approved by US regulators. However, global health groups and public health experts said the commitment was not sufficient.

Dr. Rupari J. Limei, a researcher at Johns Hopkins University who studies vaccine use and hesitation, said the United States has excess Pfizer-BioNTech shots and surpluses from other manufacturers. India Other countries that have had serious outbreaks and have sought help.

“From an ethical point of view, we should not prioritize people like them over people in countries like India,” Dr. Rimaier said of the youth.

If the United States maintains Pfizer-BioNTech’s supply, she said it should be booked for adults while health authorities work on stages of vaccination campaigns that require more. Personalized local outreach..

“We still have to get over the hesitant adults, but at the same time we probably start at the age of 14 or 15,” said Dr. Limaye. “But the priority should still be adults.”

The current vaccine supply in the United States is considerable. As of Monday, about 65 million doses were given, including 31 million doses of Pfizer-BioNTech vaccine, about 25 million doses of Modena, and 10 million doses of Johnson & Johnson, but not. According to the numbers collected by the CDC

Both the Pfizer vaccine and the modelna vaccine need to be given twice. Pfizer is certified over 16 years old and Moderna is certified over 18 years old.

Pfizer-BioNTech’s tens of millions of doses (about three weeks, according to one federal authority) have been manufactured and are in various preparatory stages, awaiting final testing before shipping.

Moderna expects immediate results from its own clinical trials in adolescents aged 12 to 17, followed by results in children aged 6 months to 12 later this year. ..

Food and Drug Administration approval could significantly alleviate concerns between middle school and high school managers planning a fall. If students can be vaccinated by then, more regular gatherings will be possible and managers will be able to plan even earlier in the school year.

FDA Set to Approve Pfizer Vaccine for Youth by Early Next Week

Source link FDA Set to Approve Pfizer Vaccine for Youth by Early Next Week

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