This resolution raises primary questions we still can’t answer: Is President Donald Trump exerting political pressure to deliver on his promise of a vaccine “before the end of the year, or perhaps even sooner”?Is it imaginable to market vaccines so temporarily, without leaving any doubts about the protection and efficacy that will discourage their use?
Here are some facts to make sense of the situation.
Is there time for a vaccine to complete all 3 stages of clinical trials until November 1?
It’s not clear. This is based in part on the fact that coronavirus spreads in communities where placebo vaccines are tested.
The two maximum complex vaccines are manufactured through Pfizer and Moderna. Both require two doses, 3 or 4 weeks apart. On Thursday, Pfizer said he was “on his way” to request a regulatory review until the end of October. On 27 July, Moderna announced that the fundamental Phase 3 clinical trial had begun, establishing efficacy in addition to safety.
What is an emergency use authorization?
The U. S. program, established in 2004, provides the U. S. Food and Drug Administration with the U. S. Food and Drug Administration. But it’s not the first time The authority to grant transitority and expedited approval to a medical medicine or device in the event of a public fitness emergency. The U. S. review procedure is less rigorous than normal approval.
During the coronavirus pandemic, the FDA granted the US a problem. But it’s not the first time A lot of evidence, some so unnecessary that the FDA then ordered them to withdraw from the market, and two treatments, but the only vaccine approved for emergency use against anthrax in 2005
The FDA said the decision to award an AAU to a COVID-19 vaccine before the final tests are completed would “be taken on a case-by-case basis” taking into account points such as “all clinical trials available”.
Pennsylvania Health Commissioner Rachel Levine said Thursday that she would “feel better” if a new vaccine had been tested prior to approval. Philadelphia Health Commissioner Thomas Farley said he probably wouldn’t present the vaccine to everyone without the final data.
What is the quality of a vaccine to download full approval?
A COVID-19 vaccine saves or reduces the severity of the disease by 50% or more, according to FDA guidelines.
FDA commissioner Stephen Hahn has been continually under pressure so the company doesn’t take shortcuts. “I need other Americans to listen to me when I say we will use the science and knowledge of those essays, and we will make sure that our main criteria of protection and effectiveness are met,” he said. said a U. S. Senate committee listening.
Is it political?
The United States recorded approximately 6. 1 million cases of COVID-19 and 186,000 deaths. The Trump administration, which has invested heavily in vaccine development, can take advantage of a pre-election victory.
Paul Offit, director of the Center for Vaccine Education at Philadelphia Children’s Hospital, who sits on the FDA’s vaccine advisory board, fears that the FDA is giving in to pressure and noted two coVID-19 questionable CEA remedies: for the drug hydroxychloroquine and plasma convalescent, which FDA officials opposed in the first place because the studies had not proven to be effective.
“These two United States were, for me, signs of caution,” Offit said.
Why is reluctance to vaccination a concern?
In this country, the “hesitation” of vaccines – skepticism about vaccines that have been massive public aptitude successes – is a developing problem, so it is feared that the avalanche of a COVID-19 vaccine will create mistrust, said José Romero, who presides over the opinion of the CDC. Committee on Immunization Practices (ACIP), an organization that will help the government that has priority access to new coronavirus vaccines.
At meetings between CDC staff and the Philadelphia Department of Public Health, public perceptions emerged: “If others don’t accept this vaccine as true, it will make our task impossible,” James Garrow, the department’s spokesman, told CDC employees. .
Offit said that even if a progressing vaccine were shown to be 75% effective, which public officials would consider fantastic, many other people would still be at risk of infection, meaning that other people deserve to wear a mask and respect social distance.
“It will be hard to sell, ” he said.
Who was the first vaccine?
Two organizations, ACIP and a newly formed organization of the National Academies of Science, Engineering and Medicine, are working on how to prioritize vaccines, as doses will be limited from the outset. reach the end of this month. It is not known who will take the final resolution on who will get the initial doses.
Both computers recommend prioritizing physical fitness because they run the greatest threat of exposure to the virus and its spread. The academies’ proposal includes nurses and lifeguards such as police and firefighters.
Both teams will most likely pay special attention to those at increased risk of serious illness and death, as well as the elderly and those with chronic diseases.
Can states start distributing vaccines in November?
Officials in Pennsylvania, New Jersey and Philadelphia say yes. Farley said it makes sense to prepare now, even if a vaccine is in a position right away. “Sooner or later we’ll have to distribute a vaccine,” he said.
Nate Wardle, spokesman for the Pennsylvania Department of Health, said the state has a team that is still preparing for primary immunization efforts. “Our existing development plans include ways to deliver vaccines to the public and high-risk groups, and added medical offices, pharmacies, and other places where other vaccines are available.
Philadelphia, along with 4 states, were invited in August to prepare a distribution plan that can be used as a style for other locations until October 1, Wardle said. Now, he said, it turns out that the CDC has asked all states to devise their own plans
A big challenge will be the vaccine garage. The Pfizer vaccine will need to be kept at less -70 degrees Celsius, which requires special freezers that are regularly found only in giant hospitals. The Modernna vaccine wants less-20 degrees. Another is to make sure that other people get any of the dosages, without problems. Spaced.