Covid-19 Vaccine Development

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Fauci "cautiously optimistic" US could have safe and effective vaccine in late fall or early winter

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers that while one can "never guarantee the safety or effectiveness" of a vaccine, he is "cautiously optimistic" that the coronavirus vaccine being developed by Moderna and his agency will be successful.

"We hope that by the time we get into late fall and early winter, we will have in fact a vaccine that we can say that would be safe and effective. One can never guarantee the safety or effectiveness unless you do the trial, but we are cautiously optimistic this will be successful," Fauci said.

"Because in the early studies with humans, the phase one study, it clearly showed that individuals who are vaccinated mounted a neutralizing antibody response that was at least comparable and in many respects better than what we see in convalescent serum from individuals who have recovered from Covid-19," Fauci added.

Some background: The phase three clinical trial of the vaccine discussed by Fauci began Monday.

The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial will be conducted at nearly 100 US research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia.

The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes.

Volunteers will receive either two 100-microgram injections of the vaccine or a placebo about 28 days apart. Investigators and participants will not know who has received the vaccine.


 
Fauci on possibility of Covid-19 vaccine being ready by late 2020 or early 2021: "I don't think it's dreaming"

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers Friday that he doesn't think it’s a dream to say that a coronavirus vaccine could be ready by the end of the year or early 2021.

"I believe it will occur," Fauci told Rep. Carolyn Maloney during a House subcommittee hearing, and emphasized that safety standards and scientific integrity are not being compromised for speed.

"I know to some people this seems like it is so fast that there might be compromising of safety and scientific integrity, and I can tell you that is absolutely not the case. The rapidity with which we're doing it is as a result of very different technologies."

Fauci said early data from Phase 1 of the vaccine being developed by Moderna and NIAID was very favorable, but he added there are also other vaccines the government is involved with.

"As I've said often and I'll repeat it for the record now: There's never a guarantee that you're going to get a safe and effective vaccine, but from everything we've seen now, in the animal data, as well as the early human data, we feel cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021. So I don't think it's dreaming, Congresswoman. I believe is the reality, and we've shown to be a reality," Fauci said.
 
Fauci hopes China and Russia are testing Covid-19 vaccines before distributing them

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers Friday that he hopes China and Russia are "actually testing the vaccine before they are administering the vaccine to anyone."

Speaking during a House subcommittee hearing, Fauci said "claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best."

Fauci explained the US is moving in a "rapid" but "prudent" way.

"We are going very quickly. I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines. I believe the program that is being sponsored by us right now, and being directed and implemented by us, is going at a very rapid speed — prudent, but rapid," Fauci said.

Some context: CNN learned earlier this week that Russia intends to be the first in the world to approve a coronavirus vaccine, in less than two weeks. And despite concerns about its safety, effectiveness and over whether the country has cut essential corners in development, interest in the vaccine has already been expressed by at least 20 countries and some US companies, Russian officials say.

Officials told CNN on Wednesday that they were working toward a date of August 10 or earlier for approval of the vaccine, which has been created by the Moscow-based Gamaleya Institute. It will be approved for public use, with frontline healthcare workers getting it first, they said.
 
Possible coronavirus vaccines will be available to Americans in phases, Fauci says

In his congressional testimony, Dr. Anthony Fauci told lawmakers that a coronavirus vaccine may not be available to all Americans immediately, but in phases.

“I believe ultimately over a period of time in 2021, if we have — and I think we will have — a safe and effective vaccine, that Americans will be able to get it,” he said. “I don't think that we'll have everybody getting it immediately in the beginning. It probably will be phased in. And that's the reason why we have the committees to do the prioritization of who should get it first. But ultimately, within a reasonable period of time, the plans now allow for any American who needs a vaccine to get it within the year 2021.”

The nation’s top infectious disease expert reiterated that he is “cautiously optimistic” that a coronavirus vaccine will be ready by the end of the year to be distributed in 2021.

He also reassured lawmakers that all safety precautions will be taken by the FDA before the vaccine is made available to the public, encouraging all Americans to take the vaccine.

“I think the American public should be assured that in the process of determining the safety and efficacy, the proper steps have been taken to determine that, and when a vaccine becomes available it's important for their own health and for the health of the country to take that vaccine.”
 
Fauci explains why the one study showing benefit of hydroxychloroquine to treat Covid was "flawed"

Dr. Anthony Fauci said again on Friday that no randomized placebo-controlled trial has shown that hydroxychloroquine works as a Covid-19 treatment.

Asked during a House subcommittee hearing about a study by a team of researchers at the Henry Ford Health System that claimed to show that hydroxychloroquine saved lives, Fauci said that study was "flawed."

"The Henry Ford hospital study that was published was a non-controlled retrospective cohort study that was confounded by a number of issues, including the fact that many of the people who were receiving hydroxychloroquine were also receiving corticosteroids, which we know from another study gives a clear benefit in reducing deaths with advanced disease. So that study is a flawed study, and I think anyone who examines it carefully, is that it is not a randomized placebo-controlled trial," Fauci explained.

When Rep. Blaine Luetkemeyer from Missouri replied that the Henry Ford study was peer-reviewed, Fauci countered by saying, "It doesn't matter. You can peer review something that's a bad study, but the fact is, it is not a randomized placebo-controlled trial."

"The point that I think is important, because we all want to keep an open mind: Any and all of the randomized placebo-controlled trials – which is the gold standard of determining if something is effective – none of them had shown any efficacy for hydroxychloroquine," Fauci said.

Fauci added that when he sees a randomized placebo-controlled trial that shows efficacy for the treatment, "I would be the first one to admit it and to promote it."

"I just have to go with the data. I don't have any horse in the game one way or the other. I just look at the data," he said.
 
Russia gears up for mass vaccination against coronavirus despite international skepticism

The laboratory behind the vaccine is now seeking regulatory approval for the drug, Russian state news agency RIA reported Saturday, and that this would be required before it could be used. Doctors and teachers would be the first to be vaccinated, he said, while mass vaccinations are planned for October.

White House coronavirus advisor Dr. Anthony Fauci, for instance, has cast doubt on the approaches to testing in both Russia and China.

"I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone," Dr. Fauci said.

"I do not believe that there will be vaccines, so far ahead of us, that we will have to depend on other countries to get us vaccines."

And Britain's Telegraph newspaper reported Saturday that London would likely reject Russia's Covid-19 vaccine due to doubts over the trial process. Russia has released no scientific data as to the safety and effectiveness of its vaccine.

Last month, Russia was accused by officials in the U.S., Canada and Britain of trying to hack and steal coronavirus vaccine data. China has also been accused by Washington of hacking into the computer systems of firms working on a Covid-19 vaccine.

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Google translation:

Clinical trials of coronavirus vaccine completed in Russia

The Gamaleya Center conducted clinical trials of the vaccine jointly with the Ministry of Defense on the base of the N.N.Burdenko military hospital. On July 20, a second group of 20 volunteers was discharged from there. The Ministry of Defense emphasized that the test results unambiguously show the development of an immune response in all volunteers, no side effects, complications or unwanted reactions, no complaints about their health were revealed.
 
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they say that people with chronic diseases struggle the most for life
 
Fauci warns against premature authorization of coronavirus vaccine

Fauci, the nation's leading infectious disease expert, told Reuters that "the one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy."

"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial," he said.

President Donald Trump has promised that a vaccine would be available by the end of the year, though vaccinologists have said that timeline is unrealistic.
 

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