WASHINGTON – Federal regulators The second stimulant of the antiviral drug Pfizer-BioNTech and Moderna coronavirus is licensed on Tuesday for anyone over the age of 50, describing the move as an effort to promote prevention and reduce the risk of serious illness if the virus is eradicated again in the coming months.
The Food and Drug Administration estimates that older people may receive an average of four shots less after their first boost. The company also awarded a second support permit for up to 12 seniors have some immune deficiencies.
This decision means that tens of millions of Americans are now eligible for what will be their fourth mine. But while the public may be tired of the repetitive, the reaction may be temporary: Federal health officials say it is possible that Americans of any age have may need another shot in the fall to prepare for any cold surgery. The hope is that by then, scientists will have to adapt their existing vaccines to be more effective and long-lasting against the various strains that have appeared since November.
Public health officials initially considered limiting secondary support to 60 or 65 percent of the average person. Peter Marks, an official with the FDA’s Department of Immunizations, said the low end of the year highlighted it because many Americans over 50 have a chronic health condition that puts them at risk. life.
While an enhanced drug continues to protect many Americans from hospitalization and death due to Covid-19, he said, 50 or more people received their first approval more than four months ago go “should be carefully considered to get another.”
The Centers for Disease Control and Prevention is smaller. In the fall, when the power goes up, the company said it has a clear benefit from the added shot.
On Tuesday, by contrast, the CDC Updated its vaccine guidelines to see if a second enhancement has now been approved. Dr. Rochelle P. Walensky, CEO of the company, says that the choice of alternative medicine “is especially important for people 65 and older and 50 and older people with health problems are increasing their risk for serious illness from Covid- 19 as they are. He is more likely to benefit from receiving enhanced medication at this time. ”About one-third of people aged 50 to 65 have significant health conditions, officials said.
FDA made a decision on the size of the data, mostly from Israel. Experts say there is strong data indicating the need for strong protection now that different types have weakened the immune system. There is little data on whether the second upgrade will provide the protection, as well as the longevity. Regulators say another drug does not pose a new safety concern.
The idea is just six months after federal regulators granted the first color color of the upgrade, another necessary booster may add Covid anti-depressant and public fatigue. Evidence now shows that the government’s decision to ultimately fail to grant the right to support – the subject of many scientific debates at the time – saved lives in winter. Although different Omicron varieties have gone up, those promoted are 21 times more likely to die from Covid and seven times more likely to stay in hospital than those without the vaccine, e.g. according to the CDC.
But at the moment, “any other treatment offers little benefit,” Drs. Eric Rubin, an infectious disease specialist at Harvard TH Chan School of Public Health. Na program sponsored by Columbia University This week, Drs. Kate O’Brien, head of immunization at the World Health Organization, said, “We are in a weak position in terms of predictions ahead of time exactly what the data is about.” fourth dose. “
The strongest data supports secondary support from the newly born Israelite which has not yet been tested by peers. Over a 40-day period this year, the researchers analyzed Covid’s mortality rate among more than half a million adults aged 60 to 100 years who received at least one promotion.
Of the 234,868 people with only one supporter, 232 died at Covid. Of the 328,597 people who received second support, 92 died in Covid. Mortality rates are “low among those who received further promotion,” the researchers said.
Officials also reviewed statistics that suggest that if the virus reappears in late spring or summer, a second strain could save thousands of lives and prevent tens of thousands. thousands of hospitals.
CDC nominated Johnson & Johnson recipients for special treatment. The agency has approved the Moderna and Pfizer vaccine over Johnson & Johnson for safety purposes.
On Tuesday, he said adults who received the first dose plus a Johnson & Johnson vaccine booster at least four months ago – one that could include more than 1.4 million people – were eligible for a second round of one-on-one anti-mRNA. The agency cited new data showing that Johnson & Johnson vaccine did not work better than the other two.
Both Pfizer and Moderna have argued for a second endorsement. Pfizer and BioNTech said data collected during Omicron waves show that their initial initial strength decreases within three to six months against both symptomatic and severe disease. Data from Israel suggests a second round of restoration of security, but researchers have not identified the recipients of those upgrades for a long time.
Dr. Paul Burton, Moderna’s chief medical officer, told CNN on Monday that the virus update did not cause the vaccine to weaken. He said, “The only way we can achieve stability and ultimately infectious diseases is to keep people, raise their level of immunity, I fear that means constant improvement. “
Both Pfizer and Moderna have clear financial incentives to promote multiple shots: They make billions of dollars in this year’s Covid vaccine market alone.
Both the FDA and the CDC have convened an external expert committee to discuss the new forecast, leading to criticism. Dr. Rubin, an FDA member, called the decision reasonable but said it was important for the agency to make the public aware of any data it relies on others to review. The company’s decision note is expected to be posted online soon.
Like other experts, Drs. Rubin said that what is really needed now is a vaccine that works better than the current one against this new model. Many studies are now underway to find it, but the first results are not expected until later this spring.
“It’s not clear if the best support should be,” he said. Marks said.
The FDA panel is to be met on April 6 to discuss what national development plans should go forward. Federal health officials recommend that mines be sought in the fall, as it is for flu. “Sometimes,” he said. Marks said, “We will realize that this is a virus that will stay with us and that we will always keep it.”
Another important decision is imminent, perhaps next month, when the FDA may decide whether to grant immunization licenses to the country’s youngest children – only one is still eligible for vaccination. Moderna plans to release data in the coming weeks from what it describes as a successful clinical trial of two treatment regimens for children under 6. Pfizer and BioNTech have stated that they anticipate results from their next three dose tests next month for children under 5..
Dr. Marks said Tuesday that the FDA will need the approval of its advisory committee before making a decision on shots for minors.
For the vast majority of about 3 percent of Americans who have a vaccine shortage, Tuesday’s decision authorized what would be a fifth drug. Twelve-year-olds and older can get a Pfizer shot, while seniors can choose between Pfizer’s and Moderna.
It is unknown at this time what he will do after leaving the post. As the epidemic subsided, the city’s enthusiasm for shooting was evident. The new disease has been reported since the third week of January, when the Omicron scale arrived.
According to the CDC plan on Tuesday, the subvariant Omicron flies more, known as BA.2, now in the midst of a new US case. The change has led to an increase in new cases in Europe. But some experts think the United States could have avoided its huge impact, partly because the Omicron model brought more Americans.
Cheryl Shell, a 71-year-old retiree in Spring Arbor, southern Michigan, said she did not wait to find out. He got his first support in November, he said, but he is desperate to get a second because he is worried about the ability to back down. He said: “I have to go for whatever security I can get.
White House communications spokeswoman Kate Bedingfield said the new capability “is a good thing and it is a straightforward one.” He said the government has a lot to offer the current candidates a second round of support.
But he echoed a theme the White House has repeatedly said in recent weeks: If public incentives are to be adopted, he said, Congress would bring in more money to pay for them.
Noah Weiland and Adeel Hassan helped with the complaint.
The FDA offers a second Coronavirus upgrade for anyone 50 years of age and older
Source link The FDA offers a second Coronavirus upgrade for anyone 50 years of age and older