FDA Will Require A COVID-19 Vaccine Be At Least 50% More Effective Than A Placebo

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The Food and Drug Administration said Tuesday that to win regulatory approval, any covid-19 vaccine will have to prevent disease, or decrease its severity, in at least 50% of the people who receive it.

The agency also said it would require drug companies to monitor the vaccine’s performance after approval for any emerging safety problems.

The agency issued the guidance for vaccine developers in conjunction with testimony by FDA Commissioner Stephen Hahn and other health officials before the Senate Health, Education, Labor and Pensions Committee on how schools and businesses can safely reopen amid the pandemic.

The standards apply to full approvals. But the agency didn’t rule out temporary approvals, called emergency use authorizations, which typically are based on less stringent requirements. The guidance said any decision on an emergency authorization would be made “on a case-by-case basis considering the target population, the characteristics of the product” and the available evidence, including clinical trial data on safety and effectiveness.

Hahn told the committee the FDA will expect developers to include a broad swath of patients, including the elderly and minorities, in any studies about potential vaccines.

The Trump administration is eager to dispel concerns the FDA may be under political pressure to OK a vaccine that has not been completely vetted for safety and efficacy. The agency was criticized for giving emergency authorization to the malaria drug hydroxychloroquine. That authorization was recently revoked after trials showed it was ineffective and the FDA got reports of heart problems caused by the drug.

Paul Offit, chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, called the guidelines “generally reassuring because the FDA said it wouldn’t approve a vaccine unless it was effective.” He has been critical of the agency’s handling of hydroxychloroquine.

Hahn said the public should be assured the agency has “not lost sight” of the importance of making independent regulatory decisions based on sound science and data. He said the FDA is committed to expedite a covid-19 vaccine, but “will not cut corners in our decision-making.”

The Wall Street Journal first reported on the issuance of the FDA guidance.

For comparison purposes with the FDA’s goal for a coronavirus vaccine, the effectiveness of the seasonal flu vaccine ranges from 40 to 60% when the vaccine is similar to circulating flu viruses, according to the Centers for Disease Control and Prevention. Effectiveness is defined as reducing the risk of having to go to the doctor. The effectiveness of last year’s vaccine was 39%, according to CDC data recently released.

Two doses of the measles, mumps and rubella vaccine are about 97% effective at preventing measles, according to the CDC.

The 50% requirement for approval of a covid-19 vaccine got mixed reviews. Peter Hotez, a vaccine expert at the Baylor College of Medicine, said that the 50% figure was “a realistic goal but not a very high bar.” He said it probably reflected the FDA’s realization that the first vaccines likely to emerge “will be, at best, partially effective.”

He anticipated that better vaccines are likely to follow. “Our first vaccine won’t be our best,” he said. Offit said he hoped a vaccine would be close to 70 or 75% effectiveness. “I would hope we could do better than 50%,” he said.

But Stephen Ostroff, former acting FDA commissioner, said he thought the 50% figure was too high. “A vaccine that has efficacy of less than 50% may still be very beneficial for people at high risk of developing the disease,” he said.

Considering that the virus “is rampaging through a lot of parts of the United States, I would certainly consider a vaccine with less than 50% efficacy,” he said.

Democrats on the Senate health committee said the administration had to make a commitment to be transparent and guided by science in approving any covid-19 vaccine. “We cannot take for granted this process will be free of political influence,” said Sen. Patty Murray of Washington, the ranking Democrat on the committee.

Hahn also said he was “optimistic” that more than one treatment for covid-19 will be available this fall. Currently, only remdesivir, an antiviral drug, has been authorized by the FDA for treating the disease. Dexamethasone, an already approved steroid, has also been shown helpful in treating covid-19 patients on ventilators, and has been recommended for some patients by the Infectious Diseases Society of America.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in his statement that the institute is studying the rates of transmission of the virus among children – a critical issue as schools attempt to open this fall. On vaccines, he said several candidates are being studied and “hopefully there will be doses available by the beginning of next year.”

(c) 2020, The Washington Post · Laurie McGinley 

{Matzav.com}

8 COMMENTS

  1. I hope and pray Matzav readers (and others) have woken to the danger of the Covid-19 vaccine. If you haven’t, tell me why not?

    • it’s funny how people are already anti this vaccine you dont even know anything about them the science hasnt been fully tested (it will be when approved) but you made up your mind because of your feelings.

  2. A letter to all those who claim that corona never existed, and to all those who claim that there never was a need for people to wear masks.
    The Torah gives the koach of bechira to each of us. There are two ways of dealing with our situation. Rav Chaim Kanievsky Shlita paskened that over Pesach, when many Yidden were r”l passing away, there was a matzav sakana in the world called corona. He paskened that at that time the halacha required that in Eretz Yisroel people must wear masks and that they were not allowed to daven with a minyan indoors. He even quoted the Mishna Berura’s psak that at times one is required according to the halacha to wear masks outdoors. Rav Chaim paskened that during the time corona was spreading the Mishna Berura’s psak applied. He himself did not attend the wedding of his grandchild because in his words in was a sakana. (I don’t recall if it was a grandchild or great-grandchild). Yes, he is elderly and I don’t know how he would have paskened for other younger grandparents. But it is clear that he paskened that there was a virus. He probably could not have explained what exactly corona is, but that did not seem to affect his decision. He also said that in America tha halacha requires that we follow the psakim of our Rabbanim. Rav Shmuel Kaminetzky Shlita also paskened halachos regarding masks during the period of Pesach and soon after. He also was paskening based on the premise that corona exists and that at the time there was a sakana. Boruch Hashem the matzav in most of our communities has greatly improved and our Gedolim have adjusted their psakim accordingly. There were different shitos among our gedolim and poskim as to the exact application of the halacha. The hanhaga of Klal Yisroel throughout the generations has been that in such a case each person would ask his Rosh Hayeshiva or Moreh Hora’ah which opinion to follow. But our Gedolim said that corona did exist.
    Another way of dealing with the situation is bringing proof that corona never existed as an independent illness, and therefore social distancing and masks were not only never necessary, but they were dangerous for us. (So far none of those people posting on Matzav that there was not ever corona has yet addressed the fact that Rav Chaim and Rav Shmuel paskened that corona existed. I am not sure why they have so far refused to explain how they know that these Gedolei Hador are mistaken.) So far I have only seen one source brought in this forum that states that corona never existed. Other than that all that brought as proof for the nonexistence of corona was the fact that as of yet nobody has figured out exactly what corona is. They say that if it can’t be explained then it can’t exist. The source that was quoted is a website called The State of the Nation. This website’s mission is to reveal the truths which the media and politicians hide from people. They reveal that corona is a political scam. However, as previously noted, this same website prints many articles revealing many other truths that most people may not know. One of those truths is that Jews practice witchcraft and magic. Jews serve many Avodah Zaras. They call the Talmud controversial, afra l’pumaihu. And they cite that there is a fairly strong likelihood that the blood libels are true. For the benefit of those who doubt me I will copy and paste the exact quote printed on the website. “That extremely harsh accusation, widely used by stalwart defenders of Israeli behavior, refers to the notorious Christian superstition, prevalent throughout most of the Middle Ages and even into more modern times, that Jews sometimes kidnapped small Christian children in order to drain their blood for use in various magic rituals, especially in connection with the Purim religious holiday. One of my more shocking discoveries of the last dozen years is that there is a fairly strong likelihood that these seemingly impossible beliefs were actually true.” The same source that reveals the truth of corona being a scam reveals the “truth” that we shecht goyim for our rituals. (I do not know what other sources there are for corona being a scam but I would advise that these sources also be checked well to see what else they claim is true).
    We all have bechira to choose what to believe. We can choose to believe Rav Chaim and Rav Shmuel and other Gedolim who pasken that corona exists, or we can choose to believe a few doctors and a website (which also considers blood libels as being fairly strongly likely as true) that corona never existed as an independent illness. The choice is up to each person.
    From experience I assume that those who claim that corona never existed will choose not to respond to the fact that Rav Chaim paskened that corona exists. I also assume that they may ignore the fact that the website they quoted considers blood libels as probably true. That is also your choice to make.

    • So are you suggesting that all those kidoshim who died due to Covid 19, were posheya and brought it upon themselves? Are you suggesting that there was no gezaira on them to die now? They were really going to live another 30 years but because they shook talmidim’s hands on Purim they were nifter early? Are you suggesting that it was NOT nigzar last Rosh Hashana that they were going to die? Are you suggesting that it was as if they jumped in front of a moving car?
      If you answered yes to any of the above questions, you are a kofer be’ikar and have no chelek in Olam Haba. You are from Korach viadaso. All your grubbeh finger dreying doesn’t change the fact that you’re a kofer. Cars, cancer, Corona, heart attacks, home burglers, swimming pools, knifes, etc etc…don’t kill people. HKBH takes a person back when his time on this world is up. There are no 2 ways about it. Locking yourself up isolated in your Mommy’s basement with 20 masks on your head, looking frighteningly concerned, and calling others names, will not save you for a single second, if your time on this world is up. No you will not live forever. Moshe Rabbeinu didn’t either.

      • Hashem certainly decreed, with uncomprehensible reasoning, that kedoshim would die at the hands of the cursed nazis, the crusaders and all that. Does that mean the nazis will not rot in hell for what they did? Anyone who has spread this virus and anyone who falsely suggested it is harmless will rot and burn along with all of our enemies.

        • okay lets say r”l a person is in a house and he smells a fire. should he call the fire department? no way! hes a koifer bikkur! how dare he trust in anything other than Hashem! the answer is that theres a thing called hishtadlus. the same way we dont just lay down and die when we get sick, we go to a doctor or take medicine, also over here. we take safety precautions to protect ourselves and other people from getting sick chalila. (not to mention youre being choilek on all the gedolei yisroel, who might know a little better than you in this issue, unless theyre also koifrim r”l)

  3. What possible side effects will there be to the new, never before tried, vaccine? I’m not going to subject myself to some fluid drug unless I know all the information.

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