Category: Covid-19 Vaccine

Russian President Vladimir Putin is shown in a file photo. (Photo by Mikhail Svetlov/Getty Images)

MOSCOW (AP) -- Russia on Tuesday became the first country to clear a coronavirus vaccine and declare it ready for use, despite international skepticism. President Vladimir Putin said that one of his daughters has already been inoculated.

Putin emphasized that the vaccine underwent the necessary tests and has proven efficient, offering a lasting immunity from the coronavirus. However, scientists at home and abroad have been sounding the alarm that the rush to start using the vaccine before Phase 3 trials -- which normally last for months and involve thousands of people -- could backfire.

Speaking at a government meeting Tuesday, Putin said that the vaccine has undergone proper testing and is safe.

"I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests," he said. "We must be grateful to those who made that first step very important for our country and the entire world."

The Russian leader added that one of his two adult daughters has received two shots of the vaccine. "She has taken part in the experiment," Putin said.

Putin said that his daughter had a temperature of 38 degrees Celsius (100.4 Fahrenheit) on the day of the first vaccine injection, and then it dropped to just over 37 degrees (98.6 Fahrenheit) on the following day. After the second shot she again had a slight increase in temperature, but then it was all over.

"She's feeling well and has high number of antibodies," Putin added. He didn't specify which of his two daughters -- Maria or Katerina -- received the vaccine.

The Health Ministry said in Tuesday's statement that the vaccine is expected to provide immunity from the coronavirus for up to two years.

Putin emphasized that vaccination will be voluntary.

Russian authorities have said that medical workers, teachers and other risk groups will be the first to be inoculated. Deputy Prime Minister Tatyana Golikova said that the vaccination of doctors could start as early as this month.

Professor Alexander Gintsburg, head of the Gamaleya Institute that developed the vaccine, said that vaccination will start while the Phase 3 trials continue. He said that initially there will be only enough doses to conduct vaccination in 10-15 of Russia's 85 regions, according to the Interfax news agency.

Russian officials have said that large-scale production of the vaccine will start in September, and mass vaccination may begin as early as October.

Russia has registered 897,599 coronavirus cases, including 15,131 deaths.

When the pandemic struck Russia, Putin ordered state officials to shorten the time of clinical trials for potential coronavirus vaccines.

Becoming the first country in the world to develop a vaccine was a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power. State television stations and other media have praised scientists working on it and presented the work as the envy of other nations.

Gintsburg raised eyebrows in May when he said that he and other researchers tried the vaccine on themselves.

Human studies started June 17 among 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first half were recruited from the military, which raised concerns that servicemen may have been pressured to participate.

Amid Russia's rush to become the first to create a vaccine, the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs.

As the trials were declared completed, questions arose about the vaccine's safety and effectiveness. Some experts scoffed at Russian authorities' assurances that the vaccine drug produced the desired immune response and caused no significant side effects, pointing out that such claims need to be backed by published scientific data.

The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out. Experts have warned that vaccines that are not properly tested can cause harm in many ways -- from a negative impact on health to creating a false sense of security or undermining trust in vaccinations.

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Russia announces it has registered a COVID-19 vaccine - KTVU San Francisco

Only half the population of Britain definitely would accept being vaccinated against Covid-19. That is the shock conclusion of a group of scientists and pollsters who have found that only 53% of a test group of citizens said they would be certain or very likely to allow themselves to be given a vaccine against the disease if one becomes available.

By contrast, one in six (16%) said they would definitely not or would be unlikely to accept a vaccine, according to research by Kings College London and Ipsos Mori. In addition, it was found that one in five (20%) said they would only be fairly likely to go ahead with inoculation.

The study found vaccine rejection was strongest among those whose beliefs reflect greater scepticism about science and who are less concerned about the impact of the Covid-19 pandemic. Likely refusal was also linked to those who tended to be less willing to wear face masks and who said they got most of their information about the disease from WhatsApp and other social media outlets.

There was also a significant age divide in responses with 22% of those in the 16-24 and 25-34 age groups saying they would be unlikely or definitely would not accept a vaccine compared with only 11% among 55-75 year-olds.

The trends revealed by the study which was based on 2,237 interviews with UK residents aged 16-75 and which was carried out online in mid-July have triggered dismay among scientists. Misperceptions about vaccines are among our most directly damaging beliefs, and theyre clearly influencing peoples intentions during the coronavirus crisis, said prof Bobby Duffy, director of Kings College Londons the Policy Institute, which led the study.

While one in six in the UK say they are unlikely to or definitely wont get a potential vaccine against Covid-19, this rises to around a third or more among certain groups, with a clear link to belief in conspiracy theories and mistrust of government, authority and science.

This point was backed by Gideon Skinner, research director at Ipsos Mori. Almost a quarter of 16-34-year-olds are saying theyre unlikely to get vaccinated for Covid-19 if one becomes available. That is deeply concerning and should serve as an important staging post for the government to combat misperceptions about vaccinations, particularly among young people.

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Covid-19: only half of Britons would definitely have vaccination - The Guardian

MOSCOW Russia has made no secret of its intention to win the global race for a COVID-19 vaccine, claiming to have a viable and effective vaccine ready to launch into production in the coming weeks.

But if Russia succeeds in being first to market with a vaccine, it will be a sign of the countrys appetite for risk as much as its scientific prowess.

Russia traditionally has been very strong in vaccines, said Kirill Dmitriev, head of the Russian Direct Investment Fund, which is financing the vaccine trials, in an interview with NBC News. The vaccine we have is actually sort of a copycat of an Ebola vaccine that was developed five years ago by the Gamaleya Institute in Moscow.

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According to Dmitriev, who took part in the vaccines early clinical trials, Russias vaccine was able to race ahead because it is a tweaked version of an earlier vaccine against the Middle East respiratory syndrome virus, which first appeared in Saudi Arabia in 2012 and is closely related to COVID-19. The MERS vaccine itself was created by using the Ebola virus as its foundation.

Russias trade minister, Denis Manturov, said Monday that vaccine production should begin as soon as September, with three Russian companies already tapped to handle mass production with a production volume of several hundred thousands of vaccine doses per month with a subsequent increase to several million by the beginning of next year.

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In shooting for such an ambitious schedule, Russias vaccine is jumping ahead of established pharmaceutical practice. Similar vaccines, such as one being developed by the University of Oxford and AstraZeneca, are still undergoing so-called phase three clinical trials and are not expected to be widely available until early 2021.

Russia is moving forward before completing similar trials, a move Dmitriev says is made possible by the fact that Russias vaccine despite being similar to Oxfords is based on vaccine technologies already tested in Russia. Both use a so-called adenoviral vector, Dmitriev said. But where Oxford uses a monkey adenovirus, Russias vaccine uses a human adenovirus.

Health experts worry that such rapid progress comes with inherent risks.

I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering it to anyone, U.S. disease expert Dr. Anthony Fauci said of Russia and Chinas race to field a vaccine. Claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best.

The Russian vaccine, developed in cooperation between the Gamaleya Institute in Moscow and a Russian Defense Ministry laboratory, has completed phase one and two clinical trials with several small groups of volunteers. A larger trial, involving up to 1,600 people, will only begin this month after initial batches of the virus go into circulation.

Russian Health Minister Mikhail Murashko told reporters over the weekend the vaccine had completed its clinical trials and was being prepared for approval by state regulators on a conditional basis. The first groups of people to be vaccinated doctors, teachers and high-risk individuals will be under some kind of observation.

In effect, Russia is conducting its phase three trials live, treating them more like a demonstrator group than a control group meant to ensure theres nothing dangerous awaiting the larger population. Russias pharma industry is preparing to launch into mass production in September. If all goes well, Murashko said, mass vaccination awaits in October.

The benefit [of our vaccine] versus other vaccine platforms is that while theyre using technology that has never, ever received regulatory approval, Russia is using technology that has previously received regulatory approval, Dmitriev said, pointing again to Russias work with Ebola and MERS human-adenovirus-based vaccines.

Despite the risks associated with cutting corners in testing a new vaccine, pushing forward with an apparently effective candidate may be Russias best way out of the coronavirus crisis.

They are accelerating the vaccine approval process, but it seems to me that the situation requires this, says Tom Adshead, director of research at Macro-Advisory, a Moscow-based consulting firm.

Almost two months after exiting one of the worlds strictest lockdowns, the decline in daily COVID-19 case growth in Russia has slowed to a glacial pace, although Moscow in the past few weeks has seen signs of a gradual increase in cases. Moscow authorities have begun to reinforce a widely ignored mask regime, but Muskovites for weeks now have lived generally without precaution.

If you want an immune population, you either need to expose lots of people to the virus and let natural selection take its course or you need a vaccine, Adshead said. The alternative is a Taiwan or New Zealand-style lockdown, which requires far more social cohesion than is available in Russia or most other countries.

Matthew Bodner is a Moscow-based producer and reporter for NBC News.

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In effort to win the global vaccine race, Russia speeds up production and slows testing - NBC News

Six companies are currently evaluating COVID-19 vaccine candidates in late-stage testing. Johnson & Johnson (NYSE:JNJ) isn't one of them.

J&J was among the first to commit resources to a major effort to fight COVID-19. It established a partnership with the U.S. government early on to develop a novel coronavirus vaccine. It's the biggest healthcare company in the world, with massive resources. And yet Johnson & Johnson lags well behind multiple rivals, both big and small.

Don't discount J&J's prospects, though. The healthcare giant's COVID-19 vaccine candidate could have an ace in the hole that just might make it the biggest winner of all.

Image source: Getty Images.

Johnson & Johnson announced the publication of results from a preclinical study of its lead vaccine candidate, Ad26.COV2-S, on July 30. You might not think preclinical results would be a big deal. After all, several of J&J's rivals in the race to develop COVID-19 vaccines have already announced results from early-stage clinical studies in humans.

The company reported that its experimental vaccine induced a robust immune response in nonhuman primates. In particular, vaccination with Ad26.COV2-S resulted in the production of high levels of neutralizing antibodies, which hold the potential to prevent infection by the coronavirus. J&J noted that its vaccine candidate provided "complete or near-complete protection in the lungs from the virus" in the animals in the preclinical study.

All of that was great news. But what really made these preclinical results stand out was that the impressive immune response was obtained with only a single dose of Ad26.COV2-S. Other COVID-19 vaccine candidates that are farther along in clinical testing require two doses.

There are a couple of key reasons why a "one-and-done" vaccine is preferable to vaccines that require multiple doses. First, a single-dose vaccine is cheaper. Second, people would be more likely to receive a single vaccine dose than they would be to get both doses of a vaccine that requires two.

It's still early, though. J&J is evaluating both one- and two-dose regimens of Ad26.COV2-S in its phase 1/2a clinical studies. The company also plans to include both dosing regimens in its planned phase 3 study. There's a possibility that testing could lead J&J to go with the two-dose approach. However, if the single-dose vaccination works as well in humans as it did in nonhuman primates, Johnson & Johnson could easily vault from laggard to leader in the COVID-19 vaccine space.

Johnson & Johnson arguably remains something of an underdog in the race to develop a COVID-19 vaccine. Even though the company expects to begin a late-stage study of Ad26.COV2-S in September, it's still well behind several other drugmakers. You also might be surprised that J&J has only won major regulatory approval for one vaccine -- ever. And that approval came last month, with European approval of the company's Ebola vaccine.

But J&J appears to be playing the long game pretty well with its COVID-19 vaccine development. It spent more time upfront to identify a candidate that could potentially be administered with only one dose. The company also is charging much less for its vaccine than its top rivals are. Last week, J&J landed a deal with the U.S. government to supply 100 million doses of Ad26.COV2-S for around $1 billion. By comparison, Pfizer and BioNTech are supplying 100 million doses to the U.S. for $1.95 billion.

Lower pricing with fewer doses required might not seem like a smart strategy. Couldn't J&J make a lot more money selling a two-dose vaccine regimen at a price more competitive with its rivals? Sure. The healthcare stock might even be up more year to date if it took this approach.

However, a single-dose vaccine would be much more attractive to governments across the world. And J&J is likely to sell it at cost while the pandemic is ongoing. After the pandemic ends, expect the company to raise its price.

Remember Aesop's fable about the tortoise and the hare? It looks like Johnson & Johnson could be the tortoise in the race to develop a COVID-19 vaccine. The tortoise might win the race in the real world -- just as it did in the fable.

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This Could Be the Ace in the Hole for Johnson & Johnson's COVID-19 Vaccine - Motley Fool

At least six candidate COVID-19 vaccines have entered phase III clinical trials. These large-scale tests will enroll tens of thousands of people in order to show whether the vaccines are safe and can protect people from the virus that causes COVID-19.

Researchers are also aiming to enroll a wider range of people in these studies, including older adults and people with other health conditions such as heart disease and diabetes.

Other health experts are calling for greater inclusion of racial and ethnic minorities, something that has not always been done with past research.

It is essential that the vaccine trials include minorities, for the very simple reason that COVID-19 is a much more serious condition for African Americans and Latinos, said Marjorie Speers, PhD, executive director of Clinical Research Pathways, a nonprofit group in Atlanta that works to increase diversity in research. Those two groups of minorities suffer more than any other group in our population.

Earlier this year, the New York Times sued the Centers for Disease Control and Prevention (CDC) to obtain racial and ethnic data on COVID-19. Its investigation found that Black and Latino people have been nearly twice as likely to die from COVID-19 as white people.

The only way were going to know if a vaccine is safe and effective for [African Americans and Latinos] is if they are included in the vaccine trials, said Speers.

Historically, however, these groups have been less likely to be included in clinical trials, in spite of the National Institutes of Health and Food and Drug Administration (FDA) both having guidelines calling for their inclusion.

For example, African Americans make up only 5 percent of participants in U.S. clinical trials, while they represent 13.3 percent of the countrys general population. Hispanics are also underrepresented in clinical trials for new treatments.

Dr. Kathryn M. Edwards, a professor of pediatrics and scientific director of the Vanderbilt Vaccine Research Program points out that the earlier COVID-19 vaccine trials have had limited racial diversity.

In the Oxford University/AstraZeneca phase I and II clinical trial published last week, over 90 percent of the 1,077 healthy volunteers were white. A similar lack of diversity was found in the Moderna phase I trial and Pfizer and BioNTechs phase I and II study.

These trials tend to be smaller, so researchers may not put as much emphasis on ensuring that the study is racially and ethnically diverse.

But the much larger phase III trials will give groups developing COVID-19 vaccines the opportunity to include a wider range of people in their studies.

In phase III trials, we certainly like to have a study population that looks like the overall population that were going to give the vaccine to, said Edwards. So we really would like to enroll people of different racial and gender and ethnic backgrounds.

Speers says that everyone involved in these trials from researchers running the study sites to pharmaceutical companies writing the protocols to the FDA need to be more proactive in making sure that minorities are appropriately represented in the phase III trials.

Healthline reached out by email to Oxford University, Moderna, and Pfizer to ask how they would ensure that their phase III trials included more diverse populations, but did not receive a response by the time of publication.

However, Edwards says some of the researchers running the COVID-19 vaccine study sites are well positioned to recruit minorities.

Some of the investigators on the phase III trials have been working on HIV treatment and prevention protocols, and have worked with a number of community groups in those initiatives, she said.

Other health experts have raised concerns that in the rush to develop a safe and effective vaccine, inclusion of minorities might get lost in the shuffle.

We cant ignore the health disparities that currently exists for African Americans and Latinos, said Speers. So we dont want to rush the development of these vaccines, and end up creating a greater health disparity because we dont know if the vaccine works in African American and Latino populations.

Dr. Bruce Y. Lee, executive director of PHICOR and professor of health policy management at CUNY Graduate School of Public Health and Health Policy, says that having diverse participation in vaccine trials also helps get communities on board with being vaccinated later on if one is approved by the FDA.

People who volunteer for these studies have a better sense of what was done during these studies, he said. And they can relay this back to their community, saying that everything was properly done.

COVID-19 vaccine trials will also need to include more older adults and people with underlying health conditions. Both of these groups are at higher risk of a severe form of COVID-19.

Including these groups in later-stage trials is the only way to know if the vaccine is safe and effective for them.

Weve seen with other vaccines that the amount of protection thats offered after giving a vaccine is dependent on the immune systems response, said Lee.

For example, we know that older adults may have weaker immune responses, he said. The same thing is true for those taking medications that suppress their immune system.

A phase II trial by Chinese researchers supported by CanSino Biologics included healthy adults up to 83 years. Modernas phase I trial also included older adults, but that data hasnt been published yet.

Going forward, the Oxford and Moderna phase III trials will both recruit older adults, as well as people with certain underlying health conditions as long as their disease is well controlled, according to information about the trials published on ClinicalTrials.gov. Pfizer also plans to recruit older adults.

So far, none of the currently active phase III trials will include children or pregnant women.

Edwards says it will be necessary to test the vaccine in those populations before the vaccine can be used widely in them. She says these studies, though, are still in the planning stage.

Overall, a more diverse study population will help ensure that a vaccine if its found to be safe and effective will work for everyone in the country.

It would really be wonderful if we could have as much diversity in our vaccine studies as we can, said Edwards. I would certainly encourage people of all racial, gender, and ethnic backgrounds to sign up to be part of the studies.

If youre interested in taking part in a clinical trial for COVID-19 vaccines or treatments, check out the COVID-19 Prevention Networks listing of studies now recruiting.

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Demographic Makeup of the COVID-19 Vaccine Trials: What We Know - Healthline

Who Will Be First in Line for a COVID-19 Vaccine?

Health experts across the United States say theyre hopeful we could see a safe and effective coronavirus vaccine early next year. That would slow the spread of the virus, potentially saving millions from becoming infected, and eventually allow the country to fully reopen. But even after a vaccine is approved, there wont be enough for everyone for everyone who wants it immediately. Meharry Medical College in Nashville is one of the dozens of institutions enrolled in Operation Warp Speed, the administrations initiative to deliver 300 million doses of a vaccine by January 2021. Soledad OBrien speaks with immunologist Dr. James E. K. Hildreth, president and CEO of Meharry, about why we may need to adjust our expectations if were hoping to see a vaccine by the end of the year.

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Who Will Be First in Line for a COVID-19 Vaccine? - Alton Telegraph

Indian equity markets managed to end the week in gains with both Nifty50 and Sensex up 1.3%and 1.2% to close at 11,214and 38,041 respectively. However, the broader market witnessed a sharp rally with Nifty Midcap100and Nifty Smallcap100 up 4.1%and 5.0%.

All the sectors ended positively except for IT (0.4%) which saw some profit booking.

Metals were the biggest gainer, up 7.8% followed by Media and Auto, both up ~4%. On the other hand, Banks and Financial Services were up 0.5% each while all the rest of the sectors gained 1-2%. FIIs were net buyers this week, buying equities worth Rs 9,496 crore while DIIs were net sellers to the tune of Rs 2135 crore.

Global cues were positive at the start of the week on the back of strong economic data and increasing hopes of a new stimulus plan.However, it turned weak after US President Donald Trump intensified the tensions with China by banning US transactions with two popular Chinese apps, WeChat and Tiktok.

On the domestic front, the RBIs MPC kept the repo/reverse repo rates unchanged at 4%/ 3.35% and maintained its policy stance at accommodative.

Further, the central bank also announced measures including a one-time restructuring of the loans to support NBFCs, HFCs, corporate debt market, and announced a relaxation on the loan-to-value (LTV) ratio for gold loans.

With the rising US-China tensions and resurging Covid-19cases, the uncertainties are increasing while the early positive development on the vaccine front remains a silver lining.

Thus the equity markets are likely to remain volatile, with more stock-specific action as the earnings season progresses.

(The writer is theheadof Retail Researchat Motilal Oswal Financial Services Ltd)

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Early development of Covid-19 vaccine is a silver lining - Deccan Herald

Most surveys have found that only about two-thirds of U.S. adults say they would probably get the vaccine.

A safe and effective vaccine could end the coronavirus pandemic, but for it to succeed, enough people will have to get inoculated.

Recent polls suggest that the U.S. is far from ready. Most surveys have found that only about two-thirds of adults say they would probably get the vaccine. While that might protect most people who get vaccinated, research suggests it may be insufficient to reach herd immunity and stop the viruss spread.

As a law professor who has written about the legal questions around vaccination laws, employment discrimination and religious exemptions, I see four possible approaches that governments and employers can take to ensure enough Americans are immunized against COVID-19.

Which ones are legal might surprise you.

Can governments require vaccinations?

The most intrusive policy would involve government mandating vaccination for all Americans, with the exception of those with a medical exemption.

People are often surprised to learn that states would likely have the legal right to enforce such a rule.

In the 1905 landmark case Jacobson v. Massachusetts, the United States Supreme Court upheld the constitutionality of a state criminal law that required all adult inhabitants of Cambridge to get a smallpox vaccine or be fined. The Supreme Court explained that an individuals liberty rights under the U.S. Constitution are not absolute and the mandatory vaccination law was necessary to promote public health and safety.

While Jacobson v. Massachusetts is over 100 years old, courts continue to rely on the reasoning of the case. State governments still occasionally enact broad compulsory vaccination policies. In 2019, in the midst of a measles outbreak, New York City mandated that anyone over six months of age who lived, went to school or worked in several ZIP codes within the city had to be vaccinated against measles or be subject to a fine.

Requiring people to be vaccinated against the SARS-CoV-2 coronavirus could similarly be justified by governments need to promote public health and safety. In late May, the New York State Bar Associations Health Law Section even recommended mandatory COVID-19 vaccination for all Americans.

Yet in the United States today, where even mask mandates are controversial, it is unlikely that many states will enact a compulsory vaccination policy for everyone. Additionally, there is a risk that heavy-handed public health tactics can backfire and escalate tensions, increase mistrust of government and unintentionally increase the influence of the anti-vaccination movement.

What if only some people must get vaccinated?

A less intrusive tactic would be for state governments to require COVID-19 vaccinations for only certain segments of the population.

All 50 states currently have some type of compulsory vaccination laws covering K-12 schoolchildren, and many states have compulsory vaccination laws covering college students. These laws typically allow for some type of medical exemption. States may also have mandatory vaccination laws covering employees in nursing homes and health care facilities.

If states required this type of targeted mandatory COVID-19 vaccination, they could cover those most at risk and those most likely to be in contact with others in ways that could stem the viruss spread.

Another approach would be legislation that requires proof of vaccination to obtain a passport, use public transportation or go to a gym.

One of the most controversial issues surrounding compulsory vaccination laws is the religious or philosophical exemption, which some states have eliminated in recent years. In the aftermath of the recent measles outbreaks, both New York and California eliminated these exemptions from vaccination laws covering schoolchildren. Courts have explained that while compulsory vaccination laws may burden religious practices, religious exemptions are not constitutionally required under the First Amendments free exercise clause since mandatory vaccination does not single out religion and is not motivated by a desire to interfere with religion.

What can employers require?

Private employers have significant flexibility for requiring vaccination. Yet few businesses outside of health care facilities have done so, partly out of fear that employees would consider these policies to be unacceptable invasions of their personal lives.

There is a risk in a unionized workplace that a mandatory vaccination policy could be struck down if it violates a collective bargaining agreement. However, unlike government-mandated policies, these would not be subject to constitutional restrictions.

Employers may also be concerned that if policies do not include significant religious exemptions, workers could sue, claiming religious discrimination. However, it is unlikely that federal law would require employers to accommodate employees requesting a religious exemption to a COVID-19 vaccine. Under Title VII of the 1964 Civil Rights Act, the federal law prohibiting religious discrimination in the workplace, employers are not required to accommodate religious employees if doing so involves more than a de minimis, or minimal cost.

Certainly, in the midst of one of the worst public health and financial crises in recent history, there is a significant cost to having an unimmunized workforce.

Setting an example

Beyond mandates and laws, employers, politicians and government agencies have other ways to encourage people to get vaccinated. In particular, the messages they send matter. That was evident in the public controversy over mask-wearing after President Donald Trump and other prominent Republicans ridiculed the precaution.

In New York, Gov. Andrew Cuomo mandated wearing face masks in public, but he also successfully convinced New Yorkers to wear them by emphasizing that doing so showed respect for others, particularly essential workers, health care providers and high-risk individuals.

Government can similarly encourage Americans to get vaccinated through education campaigns led by trusted community members, such as religious leaders or celebrities. During the New York measles outbreak, the Orthodox Jewish Nurses Association was at the forefront of educating the Orthodox Jewish community on the safety and efficacy of vaccination.

Government and employers also could make vaccines free and available at convenient locations.

As the U.S. government fast-tracks the development of potential vaccines, its important to remember that a COVID-19 vaccine will stop the virus only if enough people get vaccinated. Now is the time for governments and employers to develop policies to ensure it succeeds.

Debbie Kaminer is a law professor at Baruch College, CUNY. She wrote this for The Conversation.

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Kaminer: Could employers and states mandate COVID-19 vaccinations? Heres what the courts have ruled - Palm Beach Post

Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine.

At his urging, so did his girlfriend, his son and his daughter-in-law. All received shots last week at a clinical research site in central Florida.

My main purpose in doing this was so I could spend more time with my family and grandchildren, Coe said, noting that hes seen them only outside and from a distance since March.

Theres a lot less risk to getting the vaccine than contracting the virus, said Coe, 74, a retired cardiologist. The worst thing that can happen is if I get the placebo.

The Coes eagerness to offer up their bodies to science reflects the widespread public interest in participating in the pivotal, late-stage clinical trials of the first two COVID vaccine candidates in the United States.

Those trials began rolling out July 27. During the next two months, vaccine makers hope to recruit 60,000 Americans to roll up their sleeves to test the two vaccines, one made by Pfizer and BioNTech, a German company, and the other by biotech startup Moderna. While small tests earlier this year showed the preventives were safe and led to participants developing antibodies against the virus, the final phase 3 testing is designed to prove whether the vaccine reduces the risk of infection.

Amid a pandemic that in the U.S. has caused roughly 5 million infections and nearly 160,000 deaths while decimating the economy, the vaccine trials have drawn far more interest than is typical for a clinical trial, organizers said.

Also, the test sites pay volunteers as much as $2,000 for completing the two-year study.

We have no shortage of volunteers and we have thousands of people interested in participating, said Dr. Ella Grach, CEO of M3-Wake Research of Raleigh, North Carolina, which is conducting vaccine trials at sixsites.

Paul Evans, president of Velocity Clinical Research in Durham, North Carolina, said his company plans to recruit more than 10,000 volunteers in seven states to test COVID vaccines. At least four of Velocitys sites in Ohio, California and Oregon have already started injecting volunteers with the Moderna vaccine.

Its been phenomenal, he said. Patient recruitment is one of the biggest challenges to running trials, but this time patients have been eager to sign up.

Ive been working in this business for 30 years, said Evans. Outside of a COVID study, you might have to reach out to four or five, up to 10 people to find [one person] who is suitable.

Other vaccine candidatesare being tested abroadand more tests will be launched in the U.S. later this year.

People 18 and older are eligible to participate in the trials, and Moderna and Pfizer are pushing to include high-risk individuals such as health workers, the elderly and people with chronic conditions such as diabetes and asthma. Organizers are also seeking to enroll Blacks and Hispanics, groups hit hard by the virus.

The vaccine makers have contracted with dozens of clinical research sites across the country. About 15 have started inoculating, and it will likely take until September for all volunteers to get their first shot. The participants will get a booster shot about a month later. They are asked to keep an electronic diary to record any symptoms. Because the virus is widespread across the country, the studies are expected to be able to note differences between infection rates in those who got the vaccine and those who received a placebo.

Government health experts say they hope to know if the vaccines are working by this fall. If the trials are successful, it would likely take until early next year before a vaccine could gain federal approval to start widespread distribution.

To determine effectiveness, half of the trial participants will receive the vaccine and half a placebo.

Coe, of Leesburg, Florida, said that several hours after getting his shot on Saturday he developed chills and was tired, symptoms that lasted until Sunday afternoon. Im virtually certain that I did not get a placebo because normal saline would not do that, he said. His daughter-in-law, Lisa Coe, 46, said she did not have any reaction other than soreness at the injection site.

We are eager to get the vaccine and get on with the normal course of our lives, she said. Im not too worried about my own health, but I am worried about unknowingly transmitting it to anyone at risk.

Dr. Bruce Rankin, a physician investigator atAccel Research Sitesin DeLand, Florida, where the Coes got their shots, said more than 1,000 adults have volunteered there already.

Accel recruits on social media sites such as Facebook and Instagram. It prescreens volunteers to make sure they understand whats expected, to learn their basic health history and get other demographic information such as race.

I thought the opportunity to be part of something like this would be very cool, said Ginny Capiot, 45, of Fayetteville, North Carolina. I believe its pretty safe and there wasnt much to lose.

Capiot works in the marketing department at a hospital, where her diabetes puts her at increased risk of serious complications from the coronavirus.

Her visit to the test site last week lasted about three hours. After she filled out paperwork, health workers registered her temperature and other vital signs, gave her a COVID-19 test via a nasal swab and then took some blood. After Capiot was inoculated, she had to wait in a room in case she had any reaction. She did not.

My arm is not even sore, she said a couple of days after the vaccination.

Volunteers in DeLand are paid as much as $1,200 over the course of the two-year trial. Participants in the Velocity-run trials will each receive $1,962 in compensation for time and travel. But Evans said many are motivated by altruism.

They understand a couple of things, he said. This has to happen for us to get a resolution or a solution to the pandemic. They also understand that theres a chance if they get the active vaccine and it works, they will benefit.

Not everyone is excited to test the unproven vaccine.

Dr. Atoya Adams, principal investigator for AB Clinical Trials, which is testing the Moderna vaccine in Las Vegas, said recruiting efforts there found that some people were confused or skeptical. They mistakenly worried they could contract COVID-19 from the vaccine.

The vaccines do not include any live virus. Earlier, smaller studies showed few major safety issues.

Adams has spent a lot of time on the phone, explaining that the vaccine appears safe and that volunteers are needed to see whether its effective. Ive literally had to tell patients in prescreening, its something I would feel safe giving to myself or my family, she said.

George Washington University in Washington, D.C., hopes to enroll 500 people at its testing site, and it received inquiries from at least that many in just the first week of recruitment.

Its been overwhelming and really highlights that everyone understands the need for a vaccine, said Dr. David Diemert, professor of medicine at the GW School of Medicine and Health Sciences.

To gain an ethnically and racially diverse group, the university reached out to food banks, senior living communities and churches looking for volunteers. Participants can get paid nearly $1,100.

In Mississippi, the Hattiesburg Clinic has generated strong interest among potential volunteers, especially among health care personnel.

People who care for these COVID patients have a very healthy fear of this illness, said Rambod Rouhbakhsh, chief investigator with MediSync Clinical Research, whose Moderna vaccine trial site is the only one in Mississippi.

He expects no trouble reaching people who would be at high risk of COVID complications, including those who are obese or have diabetes or heart disease. In southern Mississippi, there are plenty of people who meet the high-risk categories, he said.

KHN(Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program ofKFF (Kaiser Family Foundation)that is not affiliated with Kaiser Permanente.

Read more about the coronavirus outbreak from Scientific Americanhere. And read coverage from our international network of magazineshere.

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Thousands Volunteer for COVID-19 Vaccine Study - Scientific American

A coronavirus vaccine will be available to poorer countries for less than $3 a dose under a new partnership between the Gates Foundation and the Serum Institute of India, the worlds largest vaccine maker.

The collaboration is meant to ensure up to 100 million doses of a COVID-19 vaccine will be available for distribution quickly to low- and middle-income countries. The arrangement also provides an option to secure additional doses if needed.

The movecomes as other governments around the world, especially in the U.S., are moving to quickly secure vaccine production and distribution rights with pharmaceutical companies.

The Gates Foundation partnership, which also includes Gavi, the Vaccine Alliance an organizationthat helps negotiate and finance vaccines for poor countries will provide upfront capital to the Serum Institute to help them increase manufacturing capacity now.

The goal is that, once a vaccine, or vaccines, gains regulatory approval, doses can be produced at scale for distribution for low-income countries as early as the first half of 2021. They will be priced at no more than $3 a dose.

Serum Institute of India is the largest vaccine manufacturer in the world by volume. It already has contracts with vaccine candidates developed by Novavax and Oxford University, in partnership with AstraZeneca.

The groups said the collaboration is meant to ensure that developing countries have access to a coronavirus vaccine and aren't left behind.

Researchers are making good progress on developing safe and effective vaccines for COVID-19, Bill Gates said in a statement. But making sure everyone has access to them, as soon as possible, will require tremendous manufacturing capacity and a global distribution network. This collaboration gives the world some of both: the power of Indias manufacturing sector and Gavis supply chain."

Both products from Novavax and Oxford-AstraZeneca have shown promise in initial trials. Novavax is set to begin phase three testing in the fall, while the late-stage Oxford trial has already begun.

Both companies have received more than $1 billion each from the Trump administration as part of its effort to secure a vaccine for the U.S.

Drugmakers have already begun signaling how much they will charge for a potential vaccine, and the prices vary considerably.

Oxford has pledged its vaccine will be available globally "at cost" for about $3 a dose, while Johnson & Johnson predicted its vaccine will cost about $10 a dose for 100 million doses. Moderna this week said it will price a two-dose regimen at as much as $74 for small-batch customers.

Last month, the U.S. agreed to payPfizerand Germanys BioNTech $1.95 billion for 100 million doses, which is about $19.50 a dose, and $39 for a two-dose regimen.

See more here:

Gates Foundation invests in $3 COVID-19 vaccine for poorer countries | TheHill - The Hill