Category: Covid-19 Vaccine

The U.S. government has awarded a $1.6 billion contract to Novavax, Inc. to develop a coronavirus vaccine.

The award to the Maryland-based company is the largest to date from the governments Operation Warp Speed initiative to fast-track the development of vaccines and other treatments for COVID-19.Chief Executive Stanley Erck said the company aims to begin delivering 100 million doses of a vaccine in the fourth quarter of this year, an endeavor he said that may be completed by January or February of next year.

Report: Britain Nears $625 mln Sanofi/GSK COVID-19 Vaccine Deal

Clinical trials are due to start in September and Sanofi has said it expects to get approval by the first half of next year, sooner than previously anticipated

The U.S. Health and Human Services Department and the Defense Department said in a joint statement that because the federal government funded the initiative, they will own the 100 million doses of investigational vaccine expected to result from the demonstration projects.

The award was granted as the number of new infections are surging in the U.S., the world leader in infections and fatalities, prompting a growing number of states and cities to reimpose lockdown measures.

The countrys preeminent infectious disease expert, Dr. Anthony Fauci, warned in an interview Monday the U.S. is still knee-deep in the first wave of this pandemic.

Novavaxs stock price soared in premarket trading on the news it had received the government funding.

WATCH: VOA Interview -Dr. Fauci optimistic about vaccine

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Novavax Awarded $1.6 Billion to Develop US COVID-19 Vaccine - Voice of America

The United States will know by the end of the year or the beginning of 2021 whether a coronavirus vaccine is safe and effective, Dr. Anthony Fauci, the nation's leading infectious diseases doctor, said Monday.

Multiple vaccine candidates are being studied, and "if things go the way it looks like they're going, one of these will enter phase 3 at the end of July," he said, referring to the final phase of clinical trials needed to determine whether a drug works.

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Other vaccine candidates will enter phase 3 trials after July, and "we hope that by end of this year, or the beginning of 2021 we will at least have an answer whether the vaccine or vaccines - plural - are safe and effective," Fauci, who is the director of the National Institute of Allergy and Infectious Diseases, said.

He took part in a conversation with Dr. Francis Collins, director of the National Institutes of Health, on Facebook Live on Monday as new cases of COVID-19 continue to surge in the U.S.

"The current state is really not good," Fauci said, adding that two days ago, there were 57,500 new cases in the U.S.

"We are still knee-deep in the first wave of this," he said. Referring to the recent increases in cases, he went on, "I would say this would not be considered a wave, it was a surge or a resurgence of infections superimposed upon a baseline, Francis, that really never got down to where we wanted to go."

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Much of the conversation focused on vaccine development.

To ensure that a vaccine will be available soon after clinical trials are complete, Fauci said, the National Institutes of Health is working with companies to start making doses of the drug before it's known whether it works or not.

And if the vaccine doesn't turn out to be safe and effective? Those doses will just have to be thrown out, he said. "But that is a financial risk, it is not a risk for safety, nor is it risk for scientific integrity," he added.

Collins acknowledged that the government's name for the development of a coronavirus vaccine dubbed "Operation Warp Speed" may give some the impression that scientists may be cutting corners for safety.

"I want to assure everybody because you and I are in all these conversations, often many times a day and late into the night that there will be no compromising on the principles of safety and efficacy," he said. "Whatever we come up with in a few months is going to be just as rigorously tested as any vaccine ever has been."

The phase 3 trials will include 30,000 people, half of whom will receive the vaccine and half of whom will not. The trials will take place in areas where there are high levels of transmission, possibly including locations outside the U.S.

The researchers will also aim to include people in high-risk groups.

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Fauci said that he and Collins are "making sure that the trials are quite well represented by the individuals who are most susceptible, not only to infection because of certain circumstances in their life, but also the fact that they are more prone to complications because of underlying comorbidities."

He also acknowledged that we don't yet know the answer to how long protection from the vaccine will last. "We're going to assume that there's a degree of protection, but we have to assume that it's going to be finite protection," Fauci said, adding that follow-up research will be needed to determine if and when people need a booster.

Collins struck an optimistic tone on vaccine development. "Youre saying this is a pretty good virus for a vaccine to work. It has the ability where natural infection does seem to be protective. It doesn't seem to mutate too rapidly compared to some others. Is that fair?"

"That is fair," Fauci agreed. "Its an RNA virus and as we know, RNA viruses mutate, but the functional consequence of that mutation so far doesnt look to be impressive."

Collins and Fauci ended the conversation urging the American people to stick with the public health guidance.

"It will end," Fauci said. "We will get through this. Hang in there. It will end, we promise you."

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Sara G. Miller is the health editor for NBC News, Health & Medical Unit.

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Fauci on a COVID-19 vaccine: 'We will at least have an answer' in the winter whether it works - NBC News

SALISBURY, Md. - If a vaccine for COVID-19 were to come out tomorrow, would you get in line? Recent polls find most people would want it, but many aren't so sure. People in Salisbury have mixed opinions.

A survey done by the Pew Research Centersays seven in 10 people would definitely or probably get the vaccine if it were available. Some people in Salisbury say they'd want to protect themselves.

"Because I want to be protected from it. I haven't got coronavirus and I don't want to get it,"Matilda Tull of Salisbury says.

Some say they'd also want to protect others.

"Because well first of all I have elderly parents who I'm quite worried about their health and if I were to get sick myself, I could possibly pass it on to them. So I want to protect my family,"Charles Baldwin of Salisbury says.

But, many people aren't jumping up so fast. They say they're skeptical.

"It's like getting the flu virus. You didn't have it before and now you got it. And, I'm older so, I'm a diabetic so it probably wouldn't be good for me,"Ronnie Godwin of Cincoteague says.

Others worry about how the vaccine would affect them.

"I don't see it as a preventative and it's something that they're not even sure of what it will do. They don't know the side effects. Even with other flu shots per say, some people still get the flu with it,"Dellophine Henry of Salisbury says.

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Debating the COVID-19 Vaccine, if and When it Comes Out - WBOC TV 16

As COVID-19 vaccines near final stages of testing, governments are also racing against each other, busy securing supply for their own countries even before key efficacy data readouts.

After signing on AstraZeneca and partner Oxford University for 100 million doses of their COVID-19 vaccine candidate, the U.K. government is nearing a 500 million ($625 million) deal with GlaxoSmithKline and Sanofi to buy 60 million doses of their investigative shot if it later proves successful, The Sunday Times reported.

The deal, the first for the vaccine, is expected to be announced in the coming days, the British newspaper said, citing people familiar with the matter.

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Sanofi and GSK joined forces in April. For their candidate, Sanofi is contributing S-protein COVID-19 antigen based on its recombinant DNA technology thats also used in its seasonal flu vaccine Flublok, and GSK is offering its vaccine booster AS03.

The U.K. government is clearly eager to pre-empt supply, as initiation of first-in-human clinical trials of the Sanofi-GSK vaccine isnt expected until September. Securing stock at this early stage reflects its fear of being excluded given that the island nation is reliant on imports of most vaccines, including those for seasonal flu. The government has anticipated this and is pre-ordering COVID-19 vaccines, a source told The Sunday Times.

Its also likely rattled by Sanofi CEO Paul Hudsons earlier comment that the U.S. would be given first access to the vaccine in return for its financial support. That statement was soon backtracked by Sanofi Chairman Serge Weinberg after backlash from France.

REALTED:Sanofi chose a proven platform over speed in its COVID-19 vaccine hunt, CEO says

Prior to the upcoming Sanofi-GSK deal, the British government ordered 100 million doses of another potential COVID-19 vaccine, dubbed AZD1222, froma collaboration between AstraZeneca and the University of Oxford.

A phase 2/3 study of AZs adenovirus-based shot kicked off late May, though phase 1 data remain under wraps. In addition to its home country, AZ has also won backing from the U.S. HHS Biomedical Advanced Research and Development Authority (BARDA) witha $1.2 billion deal that entails delivery of about 300 million vaccine doses starting this fall. A few days ago, the drugmaker penned another deal valued at $127 million to produce 30 million doses of AZD1222 for Brazil.

Besides the two European candidates, U.S. drugmakers Moderna, Johnson & Johnson, Merck & Co. and Pfizerwhich is working with German firm BioNTechare also working on their COVID-19 vaccinesbacked by the Trump administrations Operation Warp Speed.

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Sanofi, GlaxoSmithKline near $625M COVID-19 vaccine supply deal with U.K. government: report - FiercePharma

South Africa recently announced the start of the countrys first COVID-19 vaccine clinical trial. The vaccine is also being tested in the UK and Brazil. Ina Skosana spoke to the vice-president for research at the South African Medical Research Council, Professor Jeffrey Mphahlele, to find out more.

The trial is a joint effort between different stakeholders. The main player is the University of the Witwatersrand, under the leadership of Professor Shabir Madhi. The South African Medical Research Council is co-funding the project with R10 million. Other funders include the Bill and Melinda Gates Foundation and vaccine developers at the University of Oxford.

In South Africa the aim is to vaccinate around 2000 volunteers. This will happen in at least three different groups. Half of the participants will receive the experimental vaccine and half will receive placebo. Theyll be followed for about a year to assess the safety of and the immune response to the experimental vaccine.

Before enrolling the large group of volunteers, the trial will start with a group of about 50 HIV negative healthy volunteers to evaluate the vaccine safety and to a limited extend immune response. Later, the trial aims to investigate the vaccine safety and ability to mount the immune response in HIV positive volunteers. Its important to test the vaccine in a participants with HIV given the high burden of HIV and AIDS in South Africa and the continent.

Its prudent to evaluate the safety of the vaccine in this group during the clinical trial and not to wait until the vaccine is licensed. Even so, the vaccine, once licensed, will be for everybody.

At this stage, this particular vaccine candidate (ChAdOx1) is being tested in South Africa, Brazil and the UK.

If and when the vaccine is licensed, the aim is to make it a public good and available to all countries in the world rich and poor.

Its critical that developing countries are involved in clinical trials because its important to test the vaccine in different populations.

If the vaccine candidate is developed and tested in high income countries only, the efficacy may not necessarily be the same in populations living in low- and middle-income countries.

This has happened with vaccines before.

One example was the rotavirus vaccine candidates. The purpose of the rotavirus vaccine is to protect against dehydration and severe gastroenteritis. Early vaccine candidates demonstrated high efficacy of over 80% when tested in developed countries with low child mortality. But when the same vaccines were tested in low-income and middle-income countries of Africa and Asia, the efficacy was between 40% and 65%.

That did not rule out the use of rotavirus vaccines in the developing world. In fact, research has now shown that there has been a significant reduction in hospital or emergency unit admissions for acute rotavirus gastroenteritis, or mortality in children under five years old, in countries with rotavirus vaccination programmes. This was particularly true for low-income and middle-income countries with high child mortality.

There are a number of reasons why vaccine efficacy differs. These include the genetic background of the population. With the rotavirus vaccine, additional factors that are thought to affect optimal vaccine efficacy may include early age of first infection before administration of the first vaccine dose, maternal antibodies, distinct medical problems (high levels of HIV, TB, malaria, high background of enteric infections and malnutrition), and unique diversity of circulating rotavirus strains not included in the vaccines.

In the case of COVID-19 the virus seems to be genetically stable. This is a big plus.

The most important challenge is the fact that a clinical trial is being conducted in the middle of a pandemic. It means that countries are having to deal with managing a public health emergency while simultaneously setting aside resources to do research.

Public health emergencies demand a response programme that is effective and nimble. No doubt the number one priority is to save lives and contain the epidemic. The recent Ebola outbreak in West Africa was a game changer in many ways. The outbreak spiralled out of control to become a global public health emergency due to a number of factors ranging from poor health systems to lack of medical innovations. When the cause of public health emergencies is known or predictable, and the tools to respond and intervene are widely available, it is always easy to respond and save lives.

We have learned a great deal since Ebola and other outbreaks. A key lesson is that research should take centre stage and become the norm in responding to a public health emergency especially when the cause is unknown or novel like with SARS-CoV-2. Rapid and responsive research during a public health emergency should aim to optimise and field test development of new health interventions such as vaccines, therapeutics and rapid diagnostic tools. It should also include socio-behavioural research, medical anthropology research and applied and translational research.

Read more: Ebola in the DRC: the race is on between research and the virus

In the case of the COVID-19 vaccine trial in South Africa, rising numbers of infections create a conducive environment to conduct the trial because high levels of infections are needed to field test the vaccine efficacy. Doing this clinical trial at a time of low infections would take longer to yield such results. But now that the cases are spiking, we should be able to know sooner if the vaccine is likely to work or not.

As indicated above, this is not the first time research is conducted in the middle of an outbreak. Weve got experience from Ebola, and other pathogens that were associated with outbreaks and epidemics like the original SARS, the MERS coronavirus and the Zika virus. These viruses were associated with epidemics obviously not to the same magnitude as SARS-CoV-2.

Read more: Mutating coronavirus: what it means for all of us

We just need to keep a balance between saving lives and doing research. In a pandemic like this one, the priority is to save lives. But theres a limit in what we can use to save lives unless research innovation takes centre stage. Initially, the focus was on diagnostic tests. This has now shifted to treatment and the prevention regimens.

Were making strides in treatment and prevention strategies. Recent breakthroughs include the use of remdesivir from the US and dexamethasone from UK for COVID-19 related treatment.

Clinical trials are standardised so I dont see this trial being different from others. Researchers should conduct trials following established legal, ethical and regulatory procedures governing conduct of trials. These include, but are not limited to, obtaining clearance from the South African Health Products Regulatory Authority and institutional Human Research Ethics Committees.

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COVID-19 vaccine: the challenges of running a trial in the middle of a pandemic - The Conversation CA

The advent of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and the dynamics of its spread is unprecedented. It is therefore, of paramount importance to get a vaccine that can stop the spread of the virus.

But basic knowledge about the virus and kinetics of immune responses against it is still emerging. An added difficulty is that different strains of SARS-COV-2 have been reported even in the same country within six months of its emergence.

Read more: Mutating coronavirus: what it means for all of us

Vaccines are preventive or therapeutic interventions that dramatically reduce morbidity and mortality caused by infectious diseases. They are clinically simple but immunologically complex. Edward Jenner is considered to be the father of vaccinology because he developed the first vaccine to prevent smallpox over 200 years ago. This led to the global eradication of the disease and the development of more life vaccines.

Over the intervening two centuries vaccinology has developed into a multidisciplinary intervention. It involves scientists from fields such as microbiology, immunology, medicine, epidemiology, statistics, policy, manufacturing, molecular biology, public health and even ethics.

All these disciplines are being deployed in the search for a vaccine against SARS-CoV-2.

Generally, good vaccines have three essential features.

First, they must be safe to administer.

Second, they must produce the appropriate type of immunity (antibody and/or cell-mediated) for the disease in question.

Third, they must be inexpensive for the target population and they must take into account geographical, gender and age differences.

To achieve these features, vaccine development undergoes a sequence of carefully implemented ethical processes and procedures. These are staged into pre-clinical and clinical development with four developmental phases which usually span a number of decades. This is because theres a need to understand the mechanisms of protection against the pathogen, and to mitigate the potential risk of vaccine-induced adverse reactions.

This takes time. And variations almost invariably emerge.

For example, geographical variation was reported in the efficacy of the rotavirus vaccine. In Malawi and South Africa its efficacy was found to be between 49% and 77%.. But in developed countries it was 95%-96%. A recently completed study in our laboratory showed that the roundworm, Ascaris, affected the efficacy of oral rotavirus and poliovirus vaccines.

Similarly, geographic or other variations could be encountered in the development of a vaccine for COVID-19 given that cardiovascular diseases, asthma, diabetes and ageing have been reported to aggravate the infection.

Immunologically, every antigen, including vaccine, is processed by the first line of defence, the innate immune system, and if need be passed on to the adaptive immune system.

These two lines of defence are tightly linked and finely controlled to attack different antigens in different ways. The aim is to eliminate the antigens while avoiding unintended damage to the healthy parts of the body.

Vaccine effectiveness is solely dependent on the adaptive arm of immune response. In this arm, specialised cells including the B cells and T cells are the major players. They have precise specificity for germs and provide long-term protection.

When a kind of blood cell, B lymphocyte, is in contact with foreign particles it multiplies to produce many plasma cells. These secrete antibodies whose major function is neutralisation of pathogens. In the development of a COVID-19 vaccine, researchers must identify a small part of coronavirus that will elicit effective neutralising responses.

Antivirus vaccines that lead to production of non-neutralising antibodies can facilitate deposition of complexes in tissues and activate several pathways that can worsen pathologies associated with the viral infection or excessive production of inflammatory cytokines as reported in some patients with severe COVID-19. This clearly indicates that when a protective immune response is compromised, massive damage to vital organs such as the lung, liver and the kidney can occur. Thus, damaging immune responses should be avoided by any COVID-19 vaccine.

Another blood immune cell in vaccine efficacy is the T lymphocytes. For effective COVID-19 vaccine, careful activation of certain types of T cells and monitoring of their pattern of responses are essential. For example, two types of T-lymphocytes (CD8+ T cells and CD4+ Th-1 responses) are required for the removal of SARS-CoV-2. But CD4+ Th-2 responses are not responsible for the elimination of SAR-CoV-2. It is well known that accentuation of Th-2 responses supports eosinophil recruitment, airway hyper-responsiveness, mucus production, and can weaken cytolytic T cell activity to cause delayed viral clearance and airway dysfunction. This type of unwanted response has been reported after vaccination against respiratory syncytial virus infection.

The pressure to develop a COVID-19 vaccine is huge. But its development without fully understanding the kinetics of immune responses involved in the disease and the safety risks of the vaccine could bring unwarranted setbacks now and in the future.

In addition, SARS-CoV-2 might mutate in ways that would make previously effective vaccines useless.

A great many steps have to be taken in the development of any vaccine. With COVID-19, there are added complexities given that its severity appears be different across gender and age. Theres also evidence that it might be mutable and that it has different strains. Then theres the fact that its very new, which means theres still limited knowledge about immune responses to SARS-CoV-2.

In addition, a multiplicity of disciplines must be involved. A safe and effective vaccine wont be developed without detailed understanding of host-pathogen interaction. This is happening in the trials that are being currently run.

What this adds up to is that a safe and efficient COVID-19 vaccine might not be realised soon.

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Pressure is on to develop a COVID-19 vaccine, but corners can't be cut - The Conversation Africa

Who will be the first to get a COVID-19 vaccine?

Probably people in the country where the first effective vaccine is developed.

About a dozen different vaccines are in various stages of testing worldwide, including in Britain, China and the U.S. This week, Dr. Anthony Fauci, the top U.S. infectious disease expert, said he is cautiously optimistic there will be a COVID-19 vaccine by the end of the year or early 2021.

Several wealthy countries have already ordered millions of doses of those experimental vaccines.

Britain and the U.S., for example, have invested in a vaccine candidate being developed by Oxford University and produced by AstraZeneca. If it works, U.K. politicians have said Britons will be vaccinated with it. The U.S. expects to start stockpiling it this fall and also has invested in other vaccine candidates.

Groups including the vaccine alliance GAVI are also working to buy doses for poor countries and AstraZeneca has agreed to license its vaccine to Indias Serum Institute for the production of 1 billion doses. The World Health Organization is drafting guidelines for the ethical distribution of COVID-19 vaccines.

How vaccines are distributed within a country will vary. Last week, U.S. officials said they were developing a tiered system for that. The system would likely prioritize groups at greatest risk of severe complications from COVID-19 and key workers.

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Who will be the first to get a COVID-19 vaccine? - MassLive.com

Most of us wont need Covid-19 vaccine: Oxford expert explains how the pandemic is likely to end - india news - Hindustan Times "; forYoudata += ""; forYoudata += ""; forYoudata += ""; count++; if (i === 7) { return false; } }); forYouApiResponse=forYoudata; $(forutxt).html('Recommended for you'); $(foruContent).html(forYoudata); } } }); } else if(forYouApiResponse!=''){ $(forutxt).html('Recommended for you'); $(foruContent).html(forYouApiResponse); } } function getUserData(){ $.ajax({ url:"https://www.hindustantimes.com/newsletter/get-active-subscription?usertoken="+user_token, type:"GET", dataType:"json", success: function(res){ if(res.length>0) { $("[id^=loggedin]").each(function(){ $(this).hide(); }); } } }); } function postUserData(payLoad, elm){ var msgelm=$(elm).parents(".subscribe-update").nextAll("#thankumsg"); $.ajax({ url:"https://www.hindustantimes.com/newsletter/subscribe", type:"POST", data:payLoad, contentType: "application/json", dataType: "json", success: function(res){ if(res.success===true){ $(msgelm).show(); 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Most of us wont need Covid-19 vaccine: Oxford expert explains how the pandemic is likely to end - Hindustan Times

WASHINGTON Dr. Anthony Fauci, the nation's top infectious disease expert, warned lawmakers the United States is headed in the "wrong direction" with COVID-19 and could soon reach 100,000 new cases per day if the country does not get a handle on the pandemic.

Speaking before the Senate Health, Education, Labor and Pensions Committee on Tuesday, Fauci encouraged Americans to social distance, wear masks and follow the gradual re-opening guidelines that federal health officials released.

"We're going in the wrong direction if you look at the curves of new cases," said Fauci, who is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. "We need to do something about that, and we need to do it very quickly."

Across the country, the United States is now logging 40,000 new cases of COVID-19 per day, surpassing previous records.

"I would not be surprised if they go up to 100,000 a day if this does not turn around and so I am very concerned," Fauci told lawmakers.

Minnesota had 444 new confirmed cases Monday, according to the June 30 update from the state Department of Health, for a total of 36,303 positive cases.

Other states have seen a bigger surge: Texas, Arizona, Florida and California are the new hotspots, leading the nation in new COVID-19 cases and hospitalizations.

Fauci declined to estimate potential COVID-19 deaths but said the situation "could get very bad."

"It is going to be very disturbing, I will guarantee you that, because when you have an outbreak in one part of the country, even though in other parts of the country they're doing well, they are vulnerable," Fauci said.

Some states have paused some parts of their re-opening. Fauci, who wore a red cloth Washington Nationals mask that he removed to answer questions, recommended people avoid crowds and wear masks.

"If you look at what's going on and just look at some of the film clips that you've seen of people congregating, often without masks, of being in crowds and jumping over and avoiding and not paying attention to the guidelines that we very carefully put out, we're going to continue to be in a lot of trouble, and there's going to be a lot of hurt if that does not stop," Fauci said.

Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention, also joined in the plea for Americans to wear face-coverings, saying he hopes young people, in particular, can be more careful about transmission of the disease.

"We are not defenseless against this disease. We have powerful tools: social distancing, wearing a face-covering when you are in public and being disciplined about frequent hand-washing," Redfield told lawmakers. "It is critical that we all take the personal responsibility to slow the transmission of COVID-19 and embrace the universal use of face-coverings."

President Donald Trump has been critical of masks, making fun of them on his Twitter feed and refusing to wear one in public. But Republicans have started to come out more vocally in favor of face masks.

Republican Sen. Lamar Alexander of Tennessee even opened the hearing with a plea for Trump to occasionally wear a mask, even if it is not necessary for him to do so.

"Unfortunately this simple lifesaving practice has become part of a political debate that says: If you're for Trump, you don't wear a mask. If you're against Trump, you do," Alexander said. "The president has millions of admirers. They would follow his lead. It would help end this political debate. The stakes are too high for it to continue."

Last month, Alexander was exposed to a staffer who tested positive for the virus but he never became ill. He credits the mask the staffer wore for protecting him.

Fauci told lawmakers he hopes a vaccine for COVID-19 may be available as soon as early 2021 while cautioning them that there is still a long path in the scientific process to make sure the vaccine works and is safe for all people.

"There is no guarantee that we will have a safe and effective vaccine but we are cautiously optimistic that we will at least know the extent of the efficacy sometime in the winter and early part of next year," Fauci said. "Hopefully doses will be available by the beginning of next year."

Other scientists and researchers have also expressed confidence in the development of a vaccine due to both the structure of the virus and the number of scientists and pharmaceutical companies working on the effort.

"These are the things we feel aspirationally hopeful about, and we will continue to pursue this," Fauci said of the vaccine development.

Minnesota Democrat Tina Smith asked if political pressure would be brought to bear on federal agencies to announce a new vaccine in advance of the presidential election, even if the science is not actually ready.

"What I am worried about is that there is some sort of October surprise, and that there is pressure put on the decision makers here to announce the vaccine in October of 2020," Smith said.

Dr Stephen Hahn, the head of the Food and Drug Administration, said his agency would follow the science.

"I want the American people to hear me when I say we will use the science and data from the trials and we will ensure that our high levels of standards for safety and efficacy are met," Hahn said.

The FDA released new guidance on Tuesday for approval of a COVID-19 vaccine. The guidance requires a vaccine be at least 50 percent more effective than a placebo in preventing the disease. The agency also said it would not approve a vaccine unless the developers have "clearly demonstrated" proof of its safety and efficacy through a clinical trial.

Smith also grilled federal officials on whether a vaccine developer could be released from liability to fast-track approval of the vaccine and how Americans can trust the safety of the vaccine if it is developed in a relatively short time frame.

Hahn said the FDA would not release drug-makers from liability for the vaccines. And Fauci said the large clinical trials of 30,000 or more people should help build confidence in the vaccine's safety.

The Minnesota Reformer is an independent, nonprofit news organization dedicated to keeping Minnesotans informed and unearthing stories other outlets can't or won't tell..

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Sen. Smith To Feds: Will Covid-19 Vaccine Have An October Surprise? - Patch.com

Public health officials told a Senate committee Thursday that a panel of experts outside the U.S. government may help decide who gets the eventual COVID-19 vaccine first. National Institutes of Health Director Dr. Francis Collins acknowledged that the public could be wary of the U.S. government having final say on who gets the first doses.

"We think that might be something best done, in a circumstance, by an organization that is not itself governmental," Collins said in a hearing about "Operation Warp Speed," the Trump administration's plan to develop a vaccine by the end of the year. "Because it's still the case, I think, that people are a little uneasy about the government calling the shots here."

Collins said now may be the time "to actually bring together a group of big thinkers who can take a high-level view of this that can lay out a foundation of principles." He said there are already early discussions with the National Academy of Medicine, a non-profit that advises governments and businesses on health issues.

Collins said he hopes to have principles for distribution laid out by Labor Day. "It looks promising," he told the committee.

CBS News has reached out to the National Academy of Medicine for comment.

CDC Director Robert Redfield said the CDC would ultimately have the "prime responsibility" of distributing doses. Redfield emphasized the need for figuring out strategies to help vulnerable and undeserved populations, such as setting up mobile units for vaccine shots.

Collins, Redfield and acting Biomedical Advanced Research and Development Authority Director Dr. Gary Disbrow all expressed cautious optimism that the U.S. government is on track to develop a safe and effective vaccine by the end of 2020, and have 300 million doses ready in early 2021.

They said dozens of vaccine candidates are being tested now, and there could be multiple successful vaccines in the end. One potential vaccine developed by Moderna and the NIH is entering the final stage of human trials this month.

According to current CDC guidance,the first populations to get a new vaccine that's in short supply would be front-line and essential workers such as public health personnel, critical health care employees, law enforcement and the manufacturers of the vaccine. Pregnant women and toddlers are also in the first priority group. Healthy adults between the ages of 19 and 64 are expected to be the last group to get the vaccine.

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Panel of experts outside the government could determine who gets the COVID-19 vaccine first, NIH director says - CBS News