American coronavirus: Pfizer asks FDA to authorize Covid-19 vaccine for children aged 12 to 15

0
18
Biden Extends Deadline for All U.S. Adults to Be Eligible for Covid Vaccine to April 19



[]).push(function () { viAPItag.display(“vi_1088641796”) }) || []).push(function () { viAPItag.display(“vi_1088641796”) })

“It is very likely” that the FDA will allow the expansion and could act “relatively quickly,” said the acting chairman of an FDA vaccine advisory committee.

“There is a high likelihood that the data submitted supports it,” said Dr. Arnold Monto, professor of epidemiology at the University of Michigan who is the acting chair of the advisory committee for its review of Covid-19 vaccines. “I think it could be done quite quickly. “

The pharmaceutical company said in a statement that it would seek similar rulings from other authorities around the world in the coming days.

“These claims are based on data from the pivotal phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100% efficacy and Robust antibody response after vaccination with the COVID-19 Vaccine, ”Pfizer said in a statement.

The FDA currently allows the vaccine for use in people 16 years of age and older.
The FDA is unlikely to ask the chairs of the Monto committee – the Advisory Committee on Vaccines and Related Biologics – to meet to discuss expanding the use of Pfizer’s vaccine, he said.

“They won’t have a notice every time they change things,” Monto said.

The other two Covid-19 vaccines – manufactured by Moderna and Johnson & Johnson – are licensed for emergency use in people aged 18 and over.

Meanwhile, as the country battles with variants of Covid-19, more than one in 4 adults is now fully vaccinated.

While over 66 million people have received two doses, more than a third of Americans – or 112 million – have received at least one dose, according to data released Thursday by the U.S. Centers for Disease Control and Prevention.

Officials and experts are hoping to get Americans vaccinated quickly, as lockdown fatigue takes its toll and many people let their guard down just as more transmissible and perhaps deadlier variants of the virus become dominant. In that effort, all 50 states have pledged to open vaccinations to all Americans 16 and older by April 19.

“It’s almost a race between vaccinating people and this surge that looks set to increase,” Dr Anthony Fauci said earlier this week, noting that Europe is experiencing a peak, as is the one that experts are worried about. for the United States.

The United States added 79,878 new cases on Thursday, the highest since March 24. And the country is still averaging above 60,000 new cases a day – a level according to Fauci, director of the National Institute of Allergy and Infectious Diseases, puts the United States at risk for another outbreak. Experts are particularly concerned about the spread of variant B.1.1.7, first identified in the UK and now the dominant strain in the US.

“I wish we had another three or four months before this B.1.1.7 variant flare started to happen,” said Dr Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

While states like California and Vermont plan to fully reopen this summer, experts warn that to truly declare victory over Variants, Americans must get vaccinated and pursue measures such as social distancing and wearing masks. .

Four States Reporting Adverse Events to J&J Vaccine

The CDC is aware of several incidents involving adverse reactions to the Johnson & Johnson vaccine in four states, CDC spokesperson Kristen Nordlund told CNN in a statement.

“The CDC is aware of several incidents of vaccinees suffering from lightheadedness, vertigo, fainting sensation, rapid breathing, and sweating (vasovagal or related to anxiety) after COVID-19 vaccines in the country. Iowa, Colorado, Georgia and North Carolina, ”Nordlund said. .

Officials in several of those states had previously confirmed to CNN that vaccinations had been temporarily suspended due to adverse reactions to the J&J vaccine.

CNN has reached out to Johnson & Johnson for comment.

The Colorado Department of Public Health and Environment (CDPHE) on Thursday said it had determined that the adverse reaction experienced by 11 people who received the Johnson & Johnson vaccine at the Dick’s Sporting Goods Park vaccination site was “not of concern”.

Biden Extends Deadline for All U.S. Adults to Be Eligible for Covid Vaccine to April 19

“After looking at each patient’s symptoms, analyzing other vaccinations from the same batch of vaccine, and discussing with the CDC to confirm our results, we are confident that there is no cause for concern,” Dr Eric France, chief physician with Dit CDPHE.

At this time, the CDC and the FDA “are not recommending that health departments stop administering batches of COVID-19 vaccine,” the CDC spokesperson said. “The CDC performed batch analyzes of the vaccine and found no cause for concern. ”

Serious side effects from the vaccine are rare and many people will not experience any side effects. But the CDC said that “some people will have pain or swelling at the injection site or a fever, chills or headache. These usually don’t last long and are signs that your body is building up protection ”.

Meanwhile, the National Institutes of Health has started a clinical trial to determine whether people who are highly allergic or have a mast cell disorder are more likely to have an immediate allergic reaction to Moderna or Pfizer-BioNTech Covid-19 vaccines, according to the agency. Press release.

Mast cell disorder is caused by an abnormal buildup of a type of white blood cell that causes allergic reactions.

“The public has understandably been concerned about reports of rare and serious allergic reactions to Moderna and Pfizer-BioNTech COVID-19 vaccines,” Fauci said. “The information gathered during this trial will help doctors educate people with a high allergic reaction or with a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of vaccination against COVID-19 far outweigh the risks. . “

Universities aim to protect themselves against epidemics

Recent cases of Covid-19 are younger, in part because from activities like school sports and due to the vaccination of more elderly people, Fauci said on Wednesday. Now some universities are implementing policies to prevent further outbreaks among their students.

Five states account for 43% of new Covid-19 cases in the country last weekFive states account for 43% of new Covid-19 cases in the country last week

The University of Chicago has issued a stay-at-home order for students living in dormitories for the next seven days, a letter from the dean and vice president said Thursday.

The order comes after more than 50 cases of Covid-19 have been detected among the students. This is the largest cluster of cases the school has seen since the start of the school year, according to the letter.

“Many of these cases may have been linked to one or more parties hosted by off-campus fraternities over the past week,” the letter said.

Meanwhile, the University of Notre Dame in Indiana along with Syracuse University and Ithaca College in New York City are joining the growing list of colleges and universities requiring the Covid-19 vaccine for students before returning. on campuses in the fall.

Another outbreak of Covid-19 in the United States may look different, experts say, especially to young people.  here's howAnother outbreak of Covid-19 in the United States may look different, experts say, especially to young people.  here's how

Several other schools made similar announcements this week. CNN has 14 colleges and universities across the country that have announced they will require students to be fully immunized.

“After a long year, this should give all of us hope for a return to a normal campus experience,” said Chancellor of Syracuse Kent Syverud. “At every turn, you have demonstrated what it means to be Orange by navigating these extraordinary times with courage, grace and determination. Now, I ask each of you to take the next step by getting vaccinated. “

Correction: An earlier version of this story misstated how many Americans received at least one dose of the Covid-19 vaccine. That’s a third of all Americans.

Amanda Sealy, Deidre McPhillips, Hannah Sarisohn, Rebekah Riess, Ashley Ahn, Hollie Silverman, Elizabeth Stuart, Lauren Mascarenhas, Elizabeth Cohen et Amanda Watts ont contribué à ce rapport.

[]).push(function () { viAPItag.display(“vi_1088641796”) }) || []).push(function () { viAPItag.display(“vi_1088641796”) })

LEAVE A REPLY

Please enter your comment!
Please enter your name here