Tuesday, November 30News That Matters

Tag: Pfizer Inc

C.D.C. Endorses Covid Vaccine Booster Shots for All Adults

C.D.C. Endorses Covid Vaccine Booster Shots for All Adults

Technology
Faced with rising infections and an anticipated surge in holiday travel, the Centers for Disease Control and Prevention on Friday endorsed booster shots of the coronavirus vaccines for all Americans over 18.The recommendation fulfills President Biden’s pledge in August to make the extra doses available to all adults, and caps months of scientific debate over whether most people really needed boosters. The shots are already available at many drugstores, doctors’ offices and vaccination centers.The C.D.C. said that Americans over age 50, as well as those 18 and older living in long-term care facilities, “should” get booster shots of the Pfizer-BioNTech or Moderna vaccines. All other adults over age 18 “may” get booster doses, the agency decided. Recipients of Johnson & Johnson’s one-dose...
F.D.A. Authorizes Coronavirus Booster Shots for All Adults

F.D.A. Authorizes Coronavirus Booster Shots for All Adults

Technology
WASHINGTON — The Food and Drug Administration on Friday authorized booster shots of both the Pfizer-BioNTech and Moderna vaccines for everyone 18 and older, opening up eligibility to tens of millions more fully vaccinated adults.The move simplifies eligibility, fulfills a pledge by President Biden to offer the shots to every American adult and formally allows a practice already in place in at least 10 states. Fearful that waning protection and the onset of winter will set off a wave of breakthrough infections, a growing number of governors had already offered boosters to everyone 18 and older ahead of the holidays.The agency said the expansion was justified by currently available clinical trial data as well as real-world evidence. In a statement, Dr. Peter Marks, who leads the F.D.A. divis...

Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid

Business
Pfizer announced on Friday that its pill to treat Covid-19 had been found in a key clinical trial to be highly effective at preventing severe illness among at-risk people who received the drug soon after they exhibited symptoms, making it the second antiviral pill to demonstrate efficacy against Covid.The drug appears to be more effective than a similar offering from Merck, which is awaiting federal authorization. Pfizer’s pill, which will be sold under the brand name Paxlovid, cut the risk of hospitalization or death by 89 percent when given within three days after the start of symptoms.Pfizer said an independent board of experts monitoring its clinical trial recommended that the study be stopped early because the drug’s benefit to patients had proved so convincing. The company said it pl...
Covid-19 and Children: How Often Do Vaccines Cause Heart Problems?

Covid-19 and Children: How Often Do Vaccines Cause Heart Problems?

Technology
Federal regulators are reviewing data on the link between Moderna’s coronavirus vaccine and a rare heart problem in adolescents, the company announced on Sunday. That side effect — myocarditis, an inflammation of the heart muscle — has also worried advisers to federal agencies in deliberations regarding use of the Pfizer-BioNTech vaccine in younger children and teenagers.Scientists advising the Centers for Disease Control and Prevention will review the latest data on the condition at a meeting on Tuesday before deciding whether to recommend the Pfizer-BioNTech vaccine for younger children.So how common is myocarditis, really? And should parents be concerned about vaccinating their children?Absolutely not, said several experts familiar with the recent studies. While the vaccines made by Pfi...
F.D.A. Panel Recommends Vaccine for Children 5 to 11

F.D.A. Panel Recommends Vaccine for Children 5 to 11

Technology
WASHINGTON — An expert committee advising the Food and Drug Administration on Tuesday recommended that regulators authorize Pfizer-BioNTech’s coronavirus vaccine for 5- to 11-year-olds, bringing about 28 million children a major step closer to becoming eligible for shots.If the F.D.A. follows the panel’s advice in the coming days, as is expected — and the Centers for Disease Control and Prevention agrees — the Biden administration will have expanded vaccine access to all but the youngest Americans, while providing booster shots for many as well.Biden administration officials see the pediatric dose as crucial to keeping schools open and restoring a sense of normalcy to family and work life as the pandemic hurtles toward the end of its second year. The administration wants to be seen as doin...
Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

Business
Moderna’s market value has nearly tripled this year to more than $120 billion. Two of its founders, as well as an early investor, this month made Forbes magazine’s list of the 400 richest people in the United States.As the coronavirus spread in early 2020, Moderna raced to design its vaccine — which uses a new technology known as messenger RNA — and to plan a safety study. To manufacture the doses for that trial, the company received $900,000 from the nonprofit Coalition for Epidemic Preparedness Innovations.The nonprofit group said Moderna had agreed to its “equitable access principles.” That meant, according to the coalition, that the vaccine would be “first available to populations when and where they are needed and at prices that are affordable to the populations at risk, especially lo...

Biden Promised to Follow the Science. But Sometimes, He Gets Ahead of the Experts.

Technology
WASHINGTON — As he announced on Friday that booster shots would be available to some Americans, President Biden made a prediction: His administration was likely to soon provide third doses of the vaccine “across the board” to anyone who wanted one.“In the near term, we’re probably going to open this up,” he told reporters in remarks from the State Dining Room at the White House.But that assessment — a politically popular one in a country where most people vaccinated against the coronavirus say they are eager for a booster — was the latest example of how Mr. Biden and some of his team have been ahead of the nation’s top public health scientists, who have emphatically said in recent days that there is simply not enough evidence to suggest that boosters are necessary for the entire American p...
Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Technology
Wading into an acrimonious debate over booster doses, researchers in Israel reported on Wednesday that a third dose of the Pfizer-BioNTech coronavirus vaccine can prevent both infections and severe illness in adults older than 60 for at least 12 days.The study, published in the New England Journal of Medicine, is the latest salvo in the conflict over whether booster doses are needed for healthy adults and whether they should be given out, as the Biden administration plans to do, when so much of the world remains unvaccinated.Several independent scientists said the cumulative data so far suggest that only older adults will need boosters — and maybe not even them.Vaccination remains powerfully protective against severe illness and hospitalization in the vast majority of people in all of the ...
Health Officials Advise Biden to Scale Back Covid-19 Booster Shots Plan For Now

Health Officials Advise Biden to Scale Back Covid-19 Booster Shots Plan For Now

Technology
WASHINGTON — Top federal health officials have told the White House to scale back a plan to offer coronavirus booster shots to the general public this month, saying that regulators need more time to collect and review all the necessary data, according to people familiar with the discussion.Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their agencies may be able to determine in the coming weeks whether to recommend boosters only for recipients of the Pfizer-BioNTech vaccine — and possibly just some of them to start.The two health leaders made their argument in a meeting with Jeffrey D. Zients, the White House pandemic coordinator....
What to Know About Boosters if You Got the Johnson & Johnson Vaccine

What to Know About Boosters if You Got the Johnson & Johnson Vaccine

Technology
Without robust data on the long-term effectiveness of the Johnson & Johnson vaccine, it is hard for health officials to recommend boosters, said John Moore, a virologist at Weill Cornell Medicine. “If you’re doing data-driven decisions and you don’t have the data, what can you do?” he said. “This is sort of the dilemma. Public confidence in vaccines generally depends on seeing how the sausage is made, seeing that it is a data-driven, transparent process.”How effective is the Johnson & Johnson vaccine?Clinical trials, conducted before the Delta variant was widespread, found that the Johnson & Johnson vaccine had 72 percent efficacy overall in the United States, lower than the roughly 95 percent efficacy of the Pfizer and Moderna vaccines. However, it is hard to make direct compa...