Category: Covid-19 Vaccine

The race is not always to the swift, as the cocky hare learned in Aesops classic fable, The Hare and the Tortoise. Those handicapping the so-called competition to develop Covid-19 vaccines would do well to keep an eye on the slower runners in this pursuit.

Corporate giants Sanofi and Merck, which got a relatively late start in developing Covid-19 vaccines, may seem far behind the frontrunners. But experts say they also have such deep experience developing and testing vaccine candidates, and producing vaccine at commercial scale, that both could well close the gap considerably in the months ahead.

Each is developing two vaccines, in partnership with others.

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Saad Omer, a vaccinologist and director of the Yale Institute for Global Health, noted that some companies closer to the front of the pack lack Sanofis competitive advantages.

Cambridge, Mass.-based Moderna, for instance, has not yet brought a vaccine through the approval process and is now attempting to produce doses of a Covid-19 vaccine at a massive scale. It estimates it should be able to make between 500 million and 1 billion doses a year an output target that would be daunting to even a seasoned manufacturer.

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Would you rather have a company that has done scaled-up manufacturing under strict regulations and has substantial muscle memory of doing that? Omer wondered, speaking about the appeal of a vaccine veteran. That gives you some reassurance.

Robin Robinson, the former head of the Biomedical Advanced Research and Development Authority, similarly noted that Merck, with its large global footprint, has experience conducting clinical trials around the world and significant manufacturing know-how.

They can move fast, he said.

A vaccine being produced by Pfizer in partnership with BioNTech appears poised to be the first to produce data that will show if it protects against Covid-19 infection. Moderna appears to be a close second, followed by a vaccine being developed by University of Oxford and AstraZeneca the study of which is still on hold in the United States because of an adverse event in Britain and Johnson & Johnson, which started its Phase 3 trial this week. Novavax, which also has yet to bring a vaccine to market, is currently running Phase 2 trials.

Sanofi and Merck are behind this group of five. But the race for a vaccine is not a winner-take-all situation. The world is expected to need vaccines from any number of manufacturers to curb the Covid-19 pandemic, and its likely that some that arent among the first to cross the finish line will have advantages the earliest vaccines do not.

The best outcome for us is to have several across the finish line because the global need is tremendous, said Luciana Borio, a former acting chief scientist at the Food and Drug Administration who is now vice president at In-Q-Tel, a not-for-profit investment group.

Speed is just one parameter. And actually in the global scheme, its not the most important one, said Borio, who stressed the need for safe and effective Covid-19 vaccines.

Sanofi and Merck are both known to prefer underpromising and overdelivering.

Were not a flashy, you know, press-release-everyday kind of company, said Nicholas Kartsonis, who leads infectious disease clinical research for Merck Research Laboratories.

We tend to be more conservative for our positions because we know the complexities and the challenges, especially for making vaccines, said John Shiver, head of vaccine R&D for Sanofi.

Shiver initially estimated that it would take several years to develop and license a Covid-19 vaccine during a meeting with President Trump and other vaccine manufacturers at the White House in March. Trump appeared more taken with Moderna CEO Stphane Bancels projection that his company could generate clinical efficacy data for a vaccine in mere months.

Moderna, along with Pfizer and BioNTech, are making messenger-RNA vaccines, which are far quicker to develop in the early stages than some of the more established vaccine constructs. While there is hope that with that great speed, mRNA vaccines will be the answer to newly emerging diseases in future, some experts question whether the technology is ready for a prime-time debut now. Much rides on how well the vaccines stimulate the immune system and how durable that effect is.

In terms of making billions of doses, were probably a little premature for that to be as cheap and available at some of the other approaches, philanthropist Bill Gates, whose Bill and Melinda Gates Foundation funded the science behind the RNA vaccine platform, told STAT in a recent interview.

Five to 10 years from now, if things go well for that platform, it would be the primary and perhaps even the only response that we make here. So that timings a bit unfortunate, Gates said.

One of Sanofis Covid-19 candidates is an mRNA vaccine, which it is developing with Translate Bio, a Lexington, Mass.-based biotech that has been developing therapeutics using mRNA. The company has a decades worth of experience learning how to manufacture mRNA to substantial scale, Shiver said, adding the partners believe they can make between 90 million and 360 million doses of this two-dose vaccine in 2021.

The mRNA, for example, is a very interesting technology. Thats one of the reasons why were also pursuing that with a partner. But there are no licensed products with mRNA. No ones ever made hundreds of millions of doses either before, he noted, adding thePhase 1/2trial for this vaccine is expected to start by the end of November.

Shiver said the earliest the vaccine might be approved if its proven safe and effective would be the second half of 2021.

Sanofis other vaccine is being developed using the same platform the company uses to make its Flublok vaccine. Thats a plus: Theres always a greater degree of comfort and confidence on the part of regulatory agencies when a vaccine is made using a platform that they are familiar with and that has an established safety record.

(Likewise, by the time Sanofi has data on its mRNA vaccine, it may be able to benefit from the regulatory agencies evaluations of Modernas and Pfizers vaccines, Omer noted.)

This Sanofi vaccine, called a recombinant protein vaccine, will be used with an adjuvant a compound that boosts the immune systems response made by GSK.

A Phase 1/2 clinical trial involving 440 subjects, large for an early trial is already underway. Shiver said the company expects to have safety and immunogenicity data by the end of December. It also expects to have 100 million doses of the vaccine made by then should the Food and Drug Administration start to issue emergency use authorizations for Covid-19 vaccines.

Shiver said Sanofi expects to be able to produce 1 billion doses of this vaccine in 2021. The vaccine is likely to require two doses though the company is also testing a single dose.

Another advantage: This vaccine does not need to be shipped and stored at the ultra-cold temperatures of the mRNA vaccines, which makes distribution and administration easier.

One of the Merck vaccines is also being made using a platform that regulatory agencies already know. The vaccine is made by fusing genetic material from the SARS-CoV-2 virus, which causes Covid-19, onto a livestock virus that can infect people but does not sicken them. The vesicular stomatitis virus, or VSV, backbone triggers a rapid and robust immune response and all research on the backbone to date shows it does it with a single dose.

Its the same platform that was used to develop Mercks Ebola vaccine, which has shown strong results. It has not good and not very good, but outstanding efficacy said Robinson, the former head of BARDA.

Merck is developing this vaccine in conjunction with IAVI the International AIDS Vaccine Initiative which is run by former Merck chief scientist Mark Feinberg.

Kartsonis noted Mercks Ebola vaccine worked as well in the elderly as it did in young, healthy adults. Thats not a common feature of vaccines, and if the same is true for a VSV-vectored Covid vaccine, that would be a big selling point given the elderly are at the highest risk from SARS-2. There may be scenarios where this is a great vaccine for the elderly or a great vaccine for certain patient populations, Kartsonis said.

Another potential plus: IAVI is working to see if the vaccine could be given orally. A vaccine that doesnt need to be injected would be the crown jewel of having a vaccine for this, Kartsonis said.

This vaccine is not yet in clinical trials, though Merck expects to start them before the end of the year. The company said it is too soon to say when Phase 3 studies the large studies that show if a vaccine works could take place.

The second vaccine that Merck is making in collaboration with its newly acquired subsidiary, Austrian-based Themis BioScience is already in clinical trials. It uses an attenuated (weakened) measles virus as a vector with which to introduce genetic material from SARS-2 to the immune system. There are no licensed vaccines using this backbone, but clinical trials of a chikungunya virus vaccine using this approach show promise.

Timing is important. Dont get me wrong. Its very important. But at the end of the day where we all want is a vaccine that highly effective, highly well tolerated and safe and is as durable as it can be, Kartsonis said.

He and Shiver both expressed the hope that multiple vaccines will work and that others are approved before their companies products are ready for use. But both expressed a fair amount of confidence that as the Covid-19 market establishes itself, there will be some vaccines that perform better than others.

The race has started. But I mean, how many marathon runners do you know in mile 1 win a race? Kartsonis asked.

With other diseases, being fourth or fifth (or sixth or seventh) to market might make pursuit of a vaccine, even if promising, financially infeasible. But the global need for Covid-19 vaccine has introduced a whole new type of calculus to these considerations, said Omer.

Its not necessarily that the first vaccine is the one that establishes the market share, he said. Because the pie is so big.

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In the race for a Covid-19 vaccine, here come the tortoises - STAT - STAT

A Chinese pharmaceutical company said Thursday the coronavirus vaccine it is developing should be ready by early 2021 for distribution worldwide.

Yin Weidong, the CEO of SinoVac, said he personally has been given the experimental vaccine.

At the very beginning, our strategy was designed for China and for Wuhan. Soon after that in June and July we adjusted our strategy, that is to face the world, Yin said, referring to the Chinese city where the virus first emerged.

Our goal is to provide the vaccine to the world including the U.S., EU and others, Yin said.

Stringent regulations in the U.S., European Union, Japan and Australia have historically blocked the sale of Chinese vaccines. But Yin said that could change.

SinoVac is developing one of Chinas top four vaccine candidates along with state-owned SinoPharm, which has two in development, and military-affiliated private firm CanSino.

More than 24,000 people are participating in clinical trials of CoronaVac in Brazil, Turkey, and Indonesia, with additional trials scheduled for Bangladesh and possibly Chile, Yin said. SinoVac chose those countries because they all had serious outbreaks, large populations and limited research and development capacity, he said.

He spoke to reporters during a tour of a SinoVac plant south of Beijing. Built in a few months from scratch, the plant is designed to enable SinoVac to produce half a million vaccine doses a year. The bio-secure facility was already busy on Thursday filling tiny bottles with the vaccine and boxing them. The company projects it will be able to produce a few hundred million doses of the vaccine by February or March of next year.

SinoVac is also starting to test small doses of CoronaVac on children and the elderly in China after noticing rising numbers of cases globally among those two groups.

Yin said the company would prioritize distribution of the vaccine to countries hosting human trials of CoronaVac.

While the vaccine has not yet passed the phase 3 clinical trials, a globally accepted standard, SinoVac has already injected thousands of people in China under an emergency use provision.

Yin said he was one of the first to receive the experimental vaccine months ago along with researchers after phase one and two of human trials showed no serious adverse effects. He said that self-injecting showed his support for CoronaVac.

This is kind of a tradition of our company, Yin said, adding that he had done the same with a hepatitis vaccine under development.

Earlier this year, China permitted emergency use of vaccine candidates for at-risk populations like border personnel and medical workers if companies could show good safety and good antibodies from tests of about 1,000 people, Yin said.

SinoVac received that approval in June along with SinoPharm and CanSino, and was able to provide tens of thousands of doses of CoronaVac to Beijing's municipal government, Yin said.

SinoVac employees qualified for emergency use of the vaccine because an outbreak inside the company would cripple its ability to develop a vaccine, he said. About 90% of the companys staff have received it.

We are confident that our research of the COVI-19 vaccines can meet the standards of the U.S. and EU countries, Yin said.

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COVID-19 vaccine 'will be ready by early 2021', says Chinese company - Euronews

A Long Island company plans to begin a clinical trial upstate on a COVID-19 vaccine for cats, which have been found to be susceptible to the virus.

A vaccine potentially could safeguard pet owners by reducing the chance that their cats harbor the virus, said James A. Hayward, president and chief executive of Stony Brook-based Applied DNA Sciences Inc.

"By vaccinating a cat, you not only improve the health of the cat, you lower the proximal reservoir of virus available to humans," he said, noting the relationship between cats and their humans is "up close and personal."

To date, however, there have been no documented cases of cat-to-human transmission, experts said.

In a few cases, however, cats and dogs worldwide have been reported to be infected with the COVID-19 virus, mostly after close contact with humans, according to the U.S. Centers for Disease Control and Prevention.

Evidence suggests the risks of animals spreading the virus to people is low, but humans can infect animals "in some situations," said the CDC, which advises isolating pets from people who become ill.

Cats "are almost always being infected by humans" rather than other cats, said Dr. Colin Parrish, a professor of virology at Cornell University's College of Veterinary Medicine. "Most are not going to come in contact with cats outside the house. They're not going to frat parties or bars."

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Americans own 94.2 million cats, according to the American Pet Products Association's 2017-2018 National Pet Owners Survey.

Applied DNA has been developing a COVID-19 vaccine for humans in partnership with Takis Biotech, based in Rome.

In the cat trial, Applied DNA will be joining with Evvivax, a Takis spinout focused on veterinary immunotherapy and vaccines.

The clinical trial, in upstate Brewster, calls for enrolling 30 healthy domestic cats and injecting them with the vaccine once a month for three months to study safety and the cats' immune response.

The trial is scheduled to begin after clearance from the U.S. Agriculture Deparment, which regulates veterinary medicines.

The cats will be monitored for six months to track evidence of antibodies and T-cells, shown to help fight off the virus that causes COVID-19.

The feline trial also will add to the preclinical data required in developing the vaccine for use in humans, Hayward said.

In early April, the Bronx Zoo announced that a 4-year-old Malayan tiger named Nadia tested positive for the virus. Later that month, tests showed that seven other tigers and lions also tested positive.

Parrish said that barring evidence that cats are frequently infected with the virus that causes COVID-19, a vaccine likely would be reserved for special situations.

He said those might include cats that live among the elderly in nursing homes or with people who have diabetes, considered a risk factor in developing serious COVID-19 complications.

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Ken Schachter covers corporate news, including technology and aerospace, and other business topics for Newsday. He has also worked at The Miami Herald and The Jerusalem Post.

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A paw-sible COVID-19 vaccine in the works for cats - Newsday

New York Gov. Andrew Cuomo, pictured at a news conference earlier this month, said Thursday that "we're going to put together our own review committee headed by the Department of Health." Spencer Platt/Getty Images hide caption

New York Gov. Andrew Cuomo, pictured at a news conference earlier this month, said Thursday that "we're going to put together our own review committee headed by the Department of Health."

New York Gov. Andrew Cuomo says he doesn't trust the Trump administration to deliver a safe and effective COVID-19 vaccine because the approval process has become so politicized that its integrity can't be taken for granted.

At a news conference Thursday, Cuomo said state health officials will screen any federally approved vaccines.

"The first question is, is the vaccine safe? Frankly, I'm not going to trust the federal government's opinion," Cuomo said, adding, "New York state will have its own review when the federal government has finished with their review and says its safe."

The Democratic governor has often clashed with President Trump over the pandemic response.

"We're going to put together a group [of scientists] for them to review the vaccine," Cuomo said, adding that he wouldn't recommend New Yorkers get vaccinated until that state-run process is complete.

"I want to make sure we know it's safe to take," he said.

On Wednesday, the president said that if the Food and Drug Administration issues stricter guidelines for a COVID-19 vaccine, he might not approve them and accused the agency of playing politics.

"That has to be approved by the White House. We may or may not approve it. That sounds like a political move," Trump said during a press briefing at the White House.

Cuomo brought up Trump's comments during Thursday's announcement.

"The president is once again in a dispute with the FDA," Cuomo said. "The FDA says they want to make the approval more rigorous, more transparent. The president says they're trying to politicize it. Why would the FDA be politicizing the approval? Between the president and the FDA, only one entity is engaged in the political process and is headed for the Election Day. It's not the FDA."

The timing of a vaccine has increasingly been a source of contention. Trump has said a vaccine could be ready for widespread release as early as next month.

"We remain on track to deliver a vaccine before the end of the year and maybe even before Nov. 1," the president said early this month. "We think we can probably have it sometime during the month of October."

That's a timeline some of President Trump's own scientific advisers have called into question.

New York is still the state hardest-hit COVID-19, with more than 32,000 deaths so far, but stringent public health measures have sharply reduced infection rates. Roughly 1% of the state's coronavirus tests now come back positive, and the number of people dying each day has fallen into the single digits, with just two fatalities reported statewide on Wednesday.

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Cuomo Says N.Y. Health Officials Will Review Any U.S.-Approved COVID-19 Vaccine - NPR

Evaluating and Deploying Covid-19 Vaccines The Importance of Transparency, Scientific Integrity, and Public Trust  nejm.org

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Evaluating and Deploying Covid-19 Vaccines The Importance of Transparency, Scientific Integrity, and Public Trust - nejm.org

The first doses of the vaccine arrived in Murmansk on the 23rd September and vaccination started the following day, the regional government informs.

It is doctors working in especially exposed areas that are the first to get the vaccine. They will get two shots, the second to be injected 21 days after the initial dose.

Russian health authorities are now distributing the first minor shipments of the vaccine around the country. There are a series of special requirements related to the transportation, the Murmansk Ministry of Health says.

President Vladimir Putin on the 11th March announced that Russia had completed the development of its vaccine against the COVID-19. The vaccine has got the name Sputnik V.

Murmansk is among the Russian regions badly hit by the pandemic. By 25th September, a total of 14,586 people were registered as carriers of the virus. Most of the infected are from the City of Murmansk, but also several smaller towns and municipalities, including Northern Fleet naval town Severomorsk and the district of Pechenga, are seriously affected.

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COVID-19 vaccination starts in Murmansk - The Independent Barents Observer

Well, here we are. The place where no one wanted to be. COVID-19 deaths in the U.S. have surpassed 200,000 Americans. Black Americans continue to experience the highest COVID-19 mortality rates nationwide, are almost five times more likely than White Americans to be hospitalized with COVID-19 and twice as likely to die from the disease. Despite those facts, Black people are not participating in the COVID-19 vaccine trials in large numbers.

Theres a lot of discussion about the lack of participation by people of color, particularly Black people, in the vaccine trials, or in research with human subjects in general. CBS News reported that while Black people make up 18 percent of the nations population, they only represent 11 percent and 16 percent of Pfizer and Modernas vaccine trials, respectively. Both pharmaceutical companies are in phase three trials where volunteers test the effectiveness of the vaccine.

Let me share some insight from my perspective, on why there may be a low participation rate, for those of you who see it as a problem (not everyone does, you know).

As a people, Black Americans are not strangers to the disparate impact we face from infectious disease on Black Americans. People of colorminoritiesare often affected by infectious diseases disproportionately compared with their White counterparts.

Now here we are, just over 100 years later, dealing with pretty much the same sh*t.

Because of structural racism, Black Americans, along with Latinx and Indigenous Peoples, experience greater infection and mortality rates from COVID-19, from the elderly down through children of color. As I have written in previous blog posts, the fact is that the reason that pre-existing conditions, which make COVID-19 more deadly, are so widely prevalent is because of racism. Frontline workers, essential workersincluding grocery store clerks, farmworkers, transportation workers, environmental sanitation workers and others are, for the most part, people of color. The data gatheredaround the disparity in COVID-19 testing, treatment and deaths, although incomplete, speaks volumes and is reminiscent of the historical practices described above.

Now if that doesnt provide enough reasons for lack of participation, here are a few more.

Given everything I have mentioned here, which isnt nearly inclusive of everything that has occurred, is there really any wonder why many Black people dont want to be used as guinea pigs or laboratory rats, particularly when initial questions about susceptibility have not even been addressed? There is a legacy of mistreatment in medical trials and that contributes to the lack of participation by Black people.

At the same time, Black people must consider the ramifications of non-participationparticularly when it comes to ensuring the efficacy of a vaccine for people who are more at risk of infection and deaths from COVID-19. Even given the historical context I provide here, participation must be an individual decision, after much consideration.

PA Governor's office/Flickr

Posted in: Science and Democracy, Science Communication Tags: COVID-19 and the Coronavirus Pandemic, ethics, public health, Systemic Racism

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The Quandary of COVID-19 Vaccine Trials for Black Americans Who (Rightfully) Distrust Medical Researchers - Union of Concerned Scientists

Heres one way to get a lot more people to take a vaccine: require it as a condition of employment.

Private companies can adopt that policy, which could have a big impact on the uptake of the new COVID-19 vaccines now under rapid development. But such a move would be controversial.

The risk of a potential backlash can be seen in the vocal reaction against mask mandates coming from some corners. Given the current politics, imagine the potential opposition to requiring a coronavirus vaccine in order to come to the workplace.

Employers are not trying to make a political statement, but they may be accused of it, said L.J. Tan, chief strategy officer at the Immunization Action Coalition in St. Paul, Minn. Theres a lot of autonomy and independence in the U.S., and that creates constant tension with the altruistic goal of trying to protect yourself and those around you.

In the health care industry, its fairly common for employers to require vaccines. The underlying premise is that health providers must take steps to protect their most vulnerable patients.

Last year, almost 45% of health care workers said their employers required a flu shot, according to the Centers for Disease Control and Prevention. That aggressive approach paid off with 98% flu coverage among employees at those firms -- twice as high as the flu immunization rate for the general public.

Outside of health care, employers are much more likely to recommend a vaccine, rather than require it. A mandate can lead to worker objections over medical conditions, sincerely held religious beliefs and disabilities -- and their claims are protected.

In light of these exemptions and the risk of discrimination, the [Equal Employment Opportunity Commission] has advised that it is best practice to simply encourage employees to take the influenza vaccine rather than to mandate it, two lawyers wrote in July in The National Law Review.

A [COVID] mandate would be an issue for many employees, said LaToya Alexander, a lawyer for Polsinelli in Dallas and co-author of the article. Based on my clients, most dont want to require a vaccine. Were hearing a lot of, What should we do? What can we do?

Employers often go to lengths to increase the uptake of annual flu shots in order to promote a healthier workforce. Many sponsor health fairs and bring in nurses to administer the vaccines for free. Some offer prizes and other incentives, and the COVID vaccine campaign is likely to have similar elements.

Itll be like the flu shot -- plus, plus, plus, said Harry D. Jones, a longtime employment lawyer for Littler Mendelson in Dallas. There will be a lot more pressure to get it done because the cost to morale would be so great if companies have to exit the workplace again.

Many people already complain about the fatigue from social distancing and wearing masks. By next summer, if the coronavirus is still spreading rapidly, its going to be difficult for employers to accept that some workers just dont want to get a vaccine, Jones said.

Employers will say, We dont want to make this mandatory, Jones said. "The CEOs and heads of HR [human resources] dont want another drama or contentious fight. But they want to stop the quarantines and disruptions.

If we have a vaccine thats safe and working, theyre going to become frustrated and tired with just asking, he said. Companies think if they just ask nicely and tell the upside, employees will do it. But theres going to be some holdouts.

He points to the evolution over requiring masks. Many elected leaders, including Texas Gov. Greg Abbott, merely recommended that people wear face coverings in public. But as COVID-19 outbreaks grew, Abbott and others imposed mask mandates.

No ones in a rush to announce a policy on the COVID vaccine, but some companies may become pioneers. Restaurants, for example, could stand apart by having all employees vaccinated -- and bragging about COVID-safe policies. They already tout their approach to cleaning surfaces and providing curbside pickup.

Economic factors will have a lot to do with how this unfolds, especially among workers who are facing the public, said Robert Field, a law professor and health regulation expert at Drexel University in Philadelphia.

He said companies often require drug tests for employees and say the policy improves public safety. Requiring a vaccine could be considered in a similar light, especially if public recommendations dont cut it.

If political leaders are ambivalent about a vaccine, thats going to translate into public ambivalence, Field said. And Texas already has a great libertarian tradition.

Texas is a laggard on adult vaccinations, ranking dead last with Louisiana in a recent ranking. Just 25% of Texas adults had the recommended flu and pneumonia vaccines in 2018, according to the Commonwealth Fund report.

Most people wont be able to get a COVID-19 vaccine for a while because health workers and other vulnerable groups will snap up early doses, said Tan of the Immunization Action Coalition. That will give private employers more time to assess the progress and determine how far they need to go.

If 50% to 70% of their workers get vaccinated, employers wont have to do much more, Tan said. But if its just 10% or 15%, then it may become a moral and ethical imperative. They may need to do something more dramatic to make sure their people are protected.

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Employers can require workers to get a COVID-19 vaccine. Will it come to that? - The Dallas Morning News

When we finally find a safe and effective Covid-19 vaccine, every nation in the world will want it. But for a while, there wont be enough to go around. So who should get access to the first doses?

One way to answer that question is to say: The nations that discover the vaccine or that can pay those who discover it will get first dibs. All the other nations will just have to wait until more doses can be manufactured.

This is vaccine nationalism, where every nation just looks out for itself, prioritizing its citizens without regard to what happens to the citizens of lower-income countries that cant afford to buy up doses. Its a path that most ethicists think is wrong. Its also the path the United States is currently on.

September 18 was the deadline for governments around the world to join the Covax Facility, a unique financing mechanism that asks countries to pool their resources together so that humanity has a better shot at discovering a successful vaccine quickly. In return, all participating countries are promised that when that day comes, theyll get equal access to the vaccine.

Some 156 countries signed agreements with Covax, representing 64 percent of the global population. The US did not.

Bad! Bad! is how Ezekiel Emanuel, a medical ethics expert at the University of Pennsylvania, characterized Americas decision. This is an opportunity for low- and middle-income countries to get a vaccine and not just have it as a rich boys club, he told me.

Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics, also bemoaned the decision. Its just incredibly shoot-yourself-in-the-foot, on two levels, she said.

Economically, Faden argues, its in Americas self-interest to help ensure every other countrys population is vaccinated because until the fear of Covid-19 dissipates, trade and travel wont go back to normal. And health-wise, nobody is safe until everybody is safe. Thats because any Covid-19 vaccine we find is not going to be 100 percent effective. It cant fully protect everyone from getting infected, so one infected traveler entering the US can still cause an outbreak.

For these moral and pragmatic reasons, ethicists generally reject vaccine nationalism (though some think its fine for a government to prioritize its citizens within certain limits). Instead, they say we should think about distributive justice, figuring out how to get lifesaving resources to every human being in a fair way.

But that unobjectionable-sounding notion actually obscures a key question, one that ethicists are now fiercely debating: When we say we want to distribute a vaccine fairly, do we care more about equality or about equity?

Equality would mean each country gets the same proportion of vaccine doses relative to its population size, and at the same rate. Equity would mean we drive more vaccine doses to the countries most in need.

The distinction between these two approaches and which one wins out will shape who gets a vaccine quickly and wholl have to wait around, hoping they dont get sick in the meantime. Lets get clear on each approach, and understand why groups like the World Health Organization are pushing for equality right now, while some ethicists say thats a mistake.

The WHO is one of three groups leading the Covax Facility. The other two are Gavi, a public-private partnership that spearheads immunization efforts in developing countries, and the Coalition for Epidemic Preparedness Innovations, an international collaboration (formed as a Gates Foundation initiative after the West African Ebola epidemic) to make vaccines available quickly when outbreaks happen.

Covax is kind of like a mutual fund, but for vaccines. Its creating a diversified portfolio of vaccine candidates (currently, nine are in development and a further nine are under evaluation), the idea being that its better to back many candidates, knowing that some wont pan out.

Very few countries can do what the US is doing: Were backing seven horses at this point, so we can create our own diversified portfolio, Faden said. But many countries dont have the resources to do that for themselves. This is the answer to that problem.

Covax asks wealthier countries to fund the development and manufacturing of the vaccine candidates. Lower-income countries dont have to pay; theyll be supported through voluntary donations to a dedicated Covax mechanism called the Advance Market Commitment. Covax aims to buy and make available 2 billion doses by the end of 2021.

If that happens, itll be a huge deal. Covaxs effort to get countries to work with each other instead of against each other could save many lives worldwide. According to Gavi CEO Seth Berkley, its the biggest multilateral effort since the Paris climate agreement; certainly, its a big step in the right direction.

Heres how the WHO says Covax allocation should work: Once a safe and effective vaccine is discovered, there should be an initial phase where all participating countries get doses in proportion to their population, at the same rate. Essentially, 3 percent of every countrys population would get access to the vaccine before any country moves on to 4 or 5 percent. This proportional allocation would continue until every country has enough doses to vaccinate 20 percent of its population.

The WHO suggests the initial tranche of doses, aiming to cover 3 percent, would likely go to health care workers. The tranche covering 20 percent would likely go to high-risk adults, like older people and those with underlying conditions. (The WHO says 20 percent would be enough to cover these groups in most countries, though some countries have older populations and might need more. They can request enough doses for up to 50 percent of their population, but they wont receive doses for more than 20 percent until all other countries have been offered that amount.)

Soumya Swaminathan, the WHOs chief scientist, explained the rationale to a panel of reporters on September 15.

What weve done in the Fair Allocation Framework, at least in the first phase, is to go with the principle of equality, she said. Because in this case, the disease has spread across the world. It has not spared any country, high-income or low-income, whereas diseases like TB and malaria disproportionately affect low- and middle-income countries.

However, she said that after countries have received enough doses to vaccinate 20 percent of their populations, she expects to shift toward more allocation to those countries which appear to be needing it much more than other countries that is, equity.

Pressed as to why Covax doesnt adopt an equity model right from the get-go, Swaminathan candidly explained that the reason is pragmatic: If wealthier countries are told theyll have to wait in line for vaccine doses behind poorer countries, they may reject Covax.

Theres a big, big risk that if you propose a very idealistic model, you may be left with nothing, she said. She recalled the 2009 swine flu pandemic, when wealthy countries like the US scooped up most doses of the H1N1 vaccine. Low-income countries couldnt get access until later, by which point the acute phase of the pandemic was already over.

Thats the historical reality. We are trying to create a new reality, Swaminathan said. But you cannot leave behind the high-income countries. To say to them, You dont have a big problem right now and therefore you dont need the vaccine, may not be acceptable to them because the virus is there and waiting to spring back the moment people go back to normal. Without their agreement, its not going to be successful.

In other words, the WHO is conscious of the politics at play here.

Faden co-drafted the WHOs Values Framework for vaccine allocation, which does list equity among its guiding principles, even though it wouldnt kick in till later. Look, there is a real-world problem, she told me. We currently live in a global order that is profoundly unjust. We need a strategy that appeals to and works for high-income countries. The Covax Facilitys principle of simple equality for the first 20 percent is this strategic attempt to incentivize countries to get in the kind that can pay.

Other ethicists are pushing for a more idealistic framework, one that prioritizes equity from the start. Chief among them is Emanuel, the University of Pennsylvania expert. Even as he participates in several WHO working groups on Covid-19, hes trying to get the international body and other players to rethink their model.

Theres a very obvious problem, he says, with the WHOs approach: Two countries can have similar-size populations but very different Covid-19 case counts. Should they really both get enough doses to vaccinate 3 percent of their populations right off the bat? Or should we drive more help toward the country with the greatest disease burden so we save as many lives as possible?

Emanuel explained the problem with the former approach via analogy. Imagine youre an ER doctor, he told me. Youre very busy, so you walk into the ER and say each person gets five minutes of time irrespective of how sick they are. That makes no sense.

In a paper published September 11 in Science, he and a diverse group of experts propose an alternative framework called the Fair Priority Model. (Though there are a couple of other proposals out there putting forward frameworks for vaccine distribution, this is the only one that offers as substantive a model as the WHOs.)

The experts lay out a plan for distributing the vaccine in three phases. Positing that our main goal should be to avert premature deaths, they suggest using standard expected years of life lost (SEYLL) averted per dose as the criterion in phase one. They say we should give priority to countries that would reduce more SEYLL per dose.

In phase two, which aims to reduce pandemic-induced economic deprivation, they give priority to countries that would reduce more SEYLL and reduce more poverty. In phase three, which aims to end community spread, they give priority to countries with higher transmission rates.

This model offers a concrete way to reduce serious harms and prioritize disadvantaged people on an international scale. Emanuel said its more ethical than the WHOs current approach.

I wasnt born yesterday. I understand that sometimes you cant do exactly whats ethical because you need to get people to the table, he told me. But political expediency is one thing and ethics is another thing. What I object to is claiming this [WHO approach] is an ethical position. And they do claim that they use the ethics language of were being equitable and all this. But thats not transparent; thats actually false advertising.

Some might object that Emanuels own proposal is not equitable to countries with more elderly citizens: Saving them will save fewer years of life (thus netting less SEYLL per dose), but older citizens are still morally valuable.

Emanuel told me that hes heard this ageism critique a million times but that its ill-founded. (He has, it may be worth noting, idiosyncratic personal views about aging.) He noted that many surveys conducted around the world suggest that, all things being equal, the public prioritizes youth over older adults in the distribution of health resources. As a global society, we seem to value investing in youth, both because investing in them when theyre young yields greater dividends later on and because we dont want to cheat them of the chance at significant life experiences a deprivation that arguably constitutes a moral harm.

Emanuel contends that his group has arrived at the best way to enshrine three fundamental values: benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern.

We met every week, arguing, and we had a very diverse group, he said. You had utilitarians, you had people who are more Rawlsian, you had cosmopolitans who believe national borders are basically ethically irrelevant, and you had people who believe borders are very relevant. I think our position represents the best of ethics and a consensus about principles that transcends lots of different specific moral commitments.

Ultimately, is this proposal better than the WHOs? How you answer that depends somewhat on your specific moral commitments. From a utilitarians standpoint, for example, whichever proposal will do the best job at maximizing benefit and limiting harm to all people is the best approach. If the WHOs realpolitik enables it to get more paying countries into the Covax Facility, thus eventually enabling more vaccines for people who couldnt otherwise afford them, it might actually be the most ethical model.

Either way, Covax is now in business, and its multilateral, cooperative approach comes as a welcome counterpoint to the vaccine nationalism weve seen in other quarters. For countries that have signed agreements with the Facility, the next step is to cough up the cash: Payments are due October 9. This money will hopefully accelerate the development and manufacturing of the vaccine were all awaiting.

Jen Kirby contributed reporting to this article.

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Who will get the Covid-19 vaccine first? - Vox.com

Michelle Vargas of Granite City, Illinois, has always vaccinated her 10-year-old daughter, Madison. They both typically get flu shots. But when a vaccine for the coronavirus eventually comes out, Vargas will not be giving it to her daughter even if Madison's school district requires it.

"There is no way in hell I would be playing politics with my daughter's health and safety," said Vargas, 36, an online fitness instructor. If the public school Madison attends and loves says the vaccine is mandatory, "we would find other options," she said.

As pharmaceutical companies race to manufacture a Covid-19 vaccine, many people are wary of a shot that is working its way through the approval process at record speed during a highly politicized pandemic. While some professions could require employees to get the vaccine, experts say schools almost certainly will require students to potentially setting the stage for a showdown between reluctant parents and education officials.

"We want to make sure kids return to in-person learning as quickly as possible, and we do see a vaccine playing a huge part in the process," said school law attorney Brian Schwartz, an adjunct professor of education law at the University of Illinois Springfield. "This is going to be a huge issue, and I don't think most people understand that yet."

It is an especially delicate time for parents to hesitate about vaccinating their children. Vaccines have long been a hot button issue, particularly as a small but vociferous group has spread false information, such as the debunked myth that the measles-mumps-rubella shot causes autism.

As with other vaccines, the decision whether to require one for Covid-19 in schools will be made at the state and school district levels. While all 50 states require student vaccinations, a patchwork of laws allows for parental objections: All states allow for exemptions for children with medical reasons, and 45 states plus Washington, D.C., grant exemptions on the basis of religious objections, according to the National Conference of State Legislatures. On top of that, 15 states allow for philosophical exemptions for people who object to immunizations on the basis of personal, moral or other grounds.

Opponents have already started sharing outlandish lies on social media about the Covid-19 vaccines in development, but this time, conspiracy theories have not been needed to sway some who otherwise dutifully immunize their children.

A Gallup poll released in August found that 1 out of 3 Americans would not get the Covid-19 vaccine if it were ready now, even if the vaccine were free. A month later, a smaller USA Today/Suffolk University poll found that two-thirds of U.S. voters do not want to get the coronavirus vaccine when it becomes available. Those polled said that they felt there will be insufficient data on the long-term effects of a rushed vaccine and that they are suspicious that pressure from President Donald Trump ahead of the election could compromise its safety standards.

Vargas, who has never before considered herself opposed to vaccinations, shares those worries.

"I understand that time is of the essence and a lot of people want to get on with their lives," she said. "But any time anything is rushed, integrity goes out the window."

There is no question that the hunt for a worthy coronavirus vaccine is happening on an accelerated timetable.

Vaccines typically take years, sometimes decades, to develop. Yet in April, through an initiative called Operation Warp Speed, the Trump administration announced that it aimed to "deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021." It's a lofty promise that the government's top infectious diseases expert, Dr. Anthony Fauci, has said he believes could be possible although he has added that he fears that the "Star Trek"-inspired moniker of the operation could fuel public distrust in it.

The Covid-19 vaccine will come as public health officials battle a growing number of anti-vaccine hot spots across the United States, which have contributed to outbreaks of diseases such as measles that were once eradicated in this country,

It also comes as several groups are uniting in their doubts about public health initiatives, said Dr. Howard Markel, a pediatrician who is director of the Center for the History of Medicine at the University of Michigan.

"You've got anti-vaxxers who are protesting along with libertarians and anti-government people and people who don't trust science or politicians. It's not a monolithic group," he said. "I don't know how it's going to roll out, but it's not going to be pretty."

Despite the unparalleled speed of the Covid-19 vaccine trials, experts said they have confidence that the protocols for safety and efficacy are being followed. An incident this month, when reported spinal cord damage in one participant briefly halted AstraZeneca's vaccine trials, proved that "the system worked," Markel said.

Dr. Yvonne "Bonnie" Maldonado, a professor of pediatrics, epidemiology and population health at the Stanford University School of Medicine, urged parents to ask trusted providers, such as their pediatricians, for as much information as possible about the vaccine whenever it comes out.

"I don't think we can make a decision one way or the other until these trials are finished and we have the data in front of us," she said. "But I think it's even more important to emphasize that we have a lot of confidence in the vaccine development structure in the U.S. and elsewhere, and you really see that the process seems to be working well so far."

"What we want to do is certainly maximize the number of children who receive the vaccine, which will, in turn, help build herd immunity for those kids who aren't vaccinated or can't be vaccinated."

Schwartz echoed the need for parents to be educated.

"Once we do have a safe and reliable vaccine, it's really incumbent on school districts and public health departments to provide information," he said. "What we want to do is certainly maximize the number of children who receive the vaccine, which will, in turn, help build herd immunity for those kids who aren't vaccinated or can't be vaccinated."

Officials have some time to convince hesitant parents.

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, has said a Covid-19 vaccine will likely not be widely available until summer or fall 2021. And if the vaccine does get approved in the coming months, children are so far down on the priority list for it that they would not be offered it right away: Health care workers, those with underlying conditions that put them at higher risk and older people are in line to get the first batch, while teachers are among those supposed to get the second.

But some educators, particularly those returning to in-person classes, may push for students to be moved higher up in the queue. While children generally do not get as severely ill from the coronavirus as adults do, research is mixed on whether kids, especially those under 10, can transmit it as easily as adults.

At the moment, no children are included in the vaccine trials, another source of concern among some parents. Regardless, the surgeon general has authorized pharmacists to administer the future vaccine to children ages 3 and older.

Katie Otteni, 24, of Hickory, North Carolina, has never vaccinated her 22-month-old son, Dallas, and she has used the religious exemption to skirt his day care center's vaccine requirement. She and other like-minded friends embark on postcard campaigns to educate others about what they say are the dangers of vaccines, and she has been encouraged to see parents who normally do not agree with her expressing reluctance about any coming Covid-19 vaccine.

"It's crazy, because this one vaccine they feel this way towards, but if they knew there was the same situation going on with the others, they would probably think differently," said Otteni, a waitress. "But it's a start."

Doctors and public health officials disagree. Vaccinations are considered one of the 10 greatest public health achievements of the 20th century, and by and large, they have repeatedly been proven to be safe.

With the pandemic, a vaccine may be our only way out, said Dr. Lauren Grossman, an assistant professor of emergency medicine and general internal medicine at the University of Colorado School of Medicine.

"In this particular case, I don't see how we have much of a choice, to be honest," she said. "Look at what we're going through now with schools reopening."

While various childhood immunizations are required to attend public schools, the annual flu shot is not mandated in most states although this year, some school districts have deemed it necessary to reduce the possibility of simultaneous flu and Covid-19 outbreaks.

The new requirement has been met with consternation in some places. In Massachusetts, hundreds of parents protested the flu shot rule in August, holding signs in front of the State House that read, "My child, my choice," The Republican newspaper of Springfield reported.

"It's a bigger lift for school districts to require flu shots than it is for vaccines," said Dan Domenech, executive director of AASA, The School Superintendents Association, an advocacy organization for the 14,000 superintendents in the U.S. "The other vaccines you don't have to get every year. Once you have it, you have it."

The response to flu shots could be a bellwether of what school districts will face if they require the coronavirus vaccine. Domenech said he expects lawsuits from parents who do not feel comfortable injecting their children with a new vaccine should schools eventually require it, especially because each person could need two doses to gain even some immunity an even bigger ask of parents.

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But Schwartz, the education law attorney, said such lawsuits would be unlikely to hold up in court as long as schools offer an alternative to in-person learning for students whose families refuse to vaccinate them.

"My take is that as long as the school system provided the child with a quality instructional program, whether it be in person or remote, that the parent is going to have an uphill battle in a lawsuit against the district," he said.

Vargas, the Illinois mother, sees a flu shot with an extensive safety record as very different from a brand new vaccine.

"This is not something you want. Period. And if we can prevent it, we need to do so."

"People want to get it out there and go on with their lives," she said. "But at what cost?"

Markel, the medical historian, sees a greater danger in not having a vaccine. His mother died of Covid-19, and he has patients who are enduring long-lasting neurological symptoms.

"Kids can get it," he said. "This is not something you want. Period. And if we can prevent it, we need to do so."

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Many parents are hesitant to give their kids a Covid-19 vaccine. What if schools require it? - NBC News