Category: Corona Virus Vaccine

News of a good immune response in animals bodes well for testing future COVID-19 vaccines. CMB/Getty Images hide caption

News of a good immune response in animals bodes well for testing future COVID-19 vaccines.

News today from Harvard's Center for Virology and Vaccine Research may help solve a problem that future COVID-19 manufacturers are sure to face: how to make sure that new and potentially better vaccines actually work without doing extremely large and expensive studies.

Writing in the journal Nature, the researchers show that a certain class of antibodies in a monkey's blood predicted protection from COVID-19. If that hold true for humans, a relative simple blood test may show whether an experimental vaccine is working.

Here's the dilemma: Once a vaccine is approved, it's unethical to test it against a placebo. Approving new vaccine would require researchers to compare two vaccines against each other, instead of having a vaccine and a placebo--which would take a lot more people than the 30,000 for the initial trials.

Most researchers agree the key to solving this problem is finding something known as correlates of immunity.

"Correlates of immunity are very important because they give us insight into how vaccines work, says Dan H. Barouch, M.D., Ph.D., Principal Investigator at the Harvard vaccine center.

The idea is if you could measure something in a people's blood that would show whether a vaccine works or not, you could then focus more on whether the vaccine was safe--because researchers would already know it's likely effective.

"So it would be much more convenient for future testing of 19 vaccines to have a well-established correlate of protection," Barouch says.

This approach is already used in approving the annual flu vaccine. "There's a new influenza vaccine that's licensed every year," he says, because of genetic changes in the influenza virus.

"It would not be possible to do a large-scale clinical efficacy trial of an influenza vaccine candidate every single year," says Barouch, so regulators rely on correlates of protection.

The correlate of protection for the coronavirus vaccine, Barouch and his colleagues found, was neutralizing antibodies. These are antibodies that can prevent a virus from infecting cells. It's possible to test for the presence of these antibodies in people's blood.

It's been assumed all along that neutralizing antibodies were necessary for a vaccine to induce to be effective, but no one know for sure if neutralizing antibodies alone were enough.

The new research conducted with rhesus macaque monkeys suggests they are.

Researchers took blood from monkeys that had been infected with the coronavirus that causes COVID-19, and then recovered. That blood contained neutralizing antibodies to the coronavirus that helped the monkeys fight off the infection.

"We isolated [those antibodies], we purified them and then we transfer them alone into nave animals," Barouch says. Nave animals are ones who had never been sick.

They then exposed the monkeys to the coronavirus. Most showed no signs of infection, and of those receiving a higher amount of antibodies, none showed signs of infection.

The implication is if a vaccine can induce someone's immune system to make those antibodies, that alone might be sufficient to believe the vaccine will work. Some scientists have argued that vaccines must provoke other kinds of immune responses known a cellular immunity. This research suggests that might not be the case.

There are some caveats. The study was done in a small number of monkeys. Also, it's possible that human neutralizing antibodies won't work as well as the monkey neutralizing antibodies did.

Nonetheless, Barouch is bullish about the implications of this research. "This is good news for vaccines because this level of neutralizing antibodies should be readily achievable by a variety of different vaccine candidates," says Barouch.

See the article here:

Blood Tests Of Immune Response May Be Key To Future COVID-19 Vaccine Development : Shots - Health News - NPR

News of a good immune response in animals bodes well for testing future COVID-19 vaccines. CMB/Getty Images hide caption

News of a good immune response in animals bodes well for testing future COVID-19 vaccines.

News today from Harvard's Center for Virology and Vaccine Research may help solve a problem that future COVID-19 manufacturers are sure to face: how to make sure that new and potentially better vaccines actually work without doing extremely large and expensive studies.

Writing in the journal Nature, the researchers show that a certain class of antibodies in a monkey's blood predicted protection from COVID-19. If that hold true for humans, a relative simple blood test may show whether an experimental vaccine is working.

Here's the dilemma: Once a vaccine is approved, it's unethical to test it against a placebo. Approving new vaccine would require researchers to compare two vaccines against each other, instead of having a vaccine and a placebo--which would take a lot more people than the 30,000 for the initial trials.

Most researchers agree the key to solving this problem is finding something known as correlates of immunity.

"Correlates of immunity are very important because they give us insight into how vaccines work, says Dan H. Barouch, M.D., Ph.D., Principal Investigator at the Harvard vaccine center.

The idea is if you could measure something in a people's blood that would show whether a vaccine works or not, you could then focus more on whether the vaccine was safe--because researchers would already know it's likely effective.

"So it would be much more convenient for future testing of 19 vaccines to have a well-established correlate of protection," Barouch says.

This approach is already used in approving the annual flu vaccine. "There's a new influenza vaccine that's licensed every year," he says, because of genetic changes in the influenza virus.

"It would not be possible to do a large-scale clinical efficacy trial of an influenza vaccine candidate every single year," says Barouch, so regulators rely on correlates of protection.

The correlate of protection for the coronavirus vaccine, Barouch and his colleagues found, was neutralizing antibodies. These are antibodies that can prevent a virus from infecting cells. It's possible to test for the presence of these antibodies in people's blood.

It's been assumed all along that neutralizing antibodies were necessary for a vaccine to induce to be effective, but no one know for sure if neutralizing antibodies alone were enough.

The new research conducted with rhesus macaque monkeys suggests they are.

Researchers took blood from monkeys that had been infected with the coronavirus that causes COVID-19, and then recovered. That blood contained neutralizing antibodies to the coronavirus that helped the monkeys fight off the infection.

"We isolated [those antibodies], we purified them and then we transfer them alone into nave animals," Barouch says. Nave animals are ones who had never been sick.

They then exposed the monkeys to the coronavirus. Most showed no signs of infection, and of those receiving a higher amount of antibodies, none showed signs of infection.

The implication is if a vaccine can induce someone's immune system to make those antibodies, that alone might be sufficient to believe the vaccine will work. Some scientists have argued that vaccines must provoke other kinds of immune responses known a cellular immunity. This research suggests that might not be the case.

There are some caveats. The study was done in a small number of monkeys. Also, it's possible that human neutralizing antibodies won't work as well as the monkey neutralizing antibodies did.

Nonetheless, Barouch is bullish about the implications of this research. "This is good news for vaccines because this level of neutralizing antibodies should be readily achievable by a variety of different vaccine candidates," says Barouch.

Excerpt from:

Blood Tests Of Immune Response May Be Key To Future COVID-19 Vaccine Development : Shots - Health News - NPR

LONDON Britain gave emergency authorization on Wednesday to Pfizers coronavirus vaccine, leaping ahead of the United States to become the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.

The decision cleared the way for a vaccination campaign with little precedent in modern medicine, encompassing not only ultracold dry ice but also a crusade against anti-vaccine misinformation.

Britains beating the United States to authorization on a vaccine codeveloped by an American company, no less intensified pressure on U.S. regulators, who are under fire from the White House for not moving faster to get doses to people. But it also fueled concerns that Britain was acting in haste for political reasons or trying to muscle its way to the front of the line for deliveries.

European regulators on Wednesday cast doubt on the rigor of Britains review and said that the authorization was limited to specific batches of the vaccine, a claim that Pfizer denied and British officials did not address.

Britains move provoked a spirited debate among American scientists about whether U.S. regulators, who are known to be unusually meticulous, could afford to hold off any longer on authorizing a vaccine against a virus that is claiming more than 10,000 lives a day worldwide.

American regulators have argued that they lag behind if only by a matter of days because they are virtually alone in reanalyzing thousands of pages of raw data from vaccine trials before approval. Backers of that approach say it is the only way to minimize unintended damage, in lives and in public trust, from vaccines not working.

British and European regulators lean more heavily on the companies own analyses, auditing their figures occasionally but otherwise grounding their decisions on vaccine makers reports. While the more cautious American approach can be valuable, some scientists said the Europeans subject vaccine makers to considerable scrutiny, and it is imperative to move quickly to curb the suffering wrought by the pandemic.

When you say its OK to wait another week or two, youre saying its OK that many thousands of people are going to die, said Dr. Walid F. Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

No country until Wednesday had authorized a fully tested coronavirus vaccine; Russia and China approved vaccines without waiting for large-scale efficacy tests.

The British government, battered by its handling of the pandemic, exulted in the authorization.

Help is on its way with this vaccine and we can now say that with certainty, rather than with all the caveats, the British health secretary, Matt Hancock, said Wednesday.

While the go-ahead bodes well for Britain, which broke from the European Unions regulatory orbit to approve the vaccine early, it will have no effect on the distribution of the hundreds of millions of doses that the United States and other wealthy countries have procured in prepaid contracts.

It also offers little relief to poorer countries that could not afford to buy supplies in advance and may struggle to pay for both the vaccines and the exceptional demands of distributing them.

Roughly 800,000 doses of the Pfizer vaccine, developed with BioNTech, a smaller German firm, were being packaged at the companys Belgian manufacturing plant on Wednesday for shipment to Britain. How and when they will arrive is a secret for security reasons, the company said.

The complicated logistics of moving, defrosting and preparing the vaccine meant it was going to be given only at 50 British hospitals to begin with. The vaccine must be transported at South Pole-like temperatures, and in trays of 975 doses.

First to be vaccinated will be doctors and nurses in the countrys National Health Service, along with nursing home workers and people 80 and over with previously scheduled doctors appointments. A government advisory committee has suggested that older or more vulnerable health workers, and doctors and nurses who work with fragile patients, would be among the first in line.

But the government has not said when other employees of the National Health Service would be eligible for vaccines. Essential workers, like teachers, transport workers and first responders, would not be vaccinated until after people 50 and over and those with underlying health problems received shots.

The advisory committee plans had made nursing home residents a top priority, but they will have to wait until the government begins distributing vaccines beyond hospitals. Pfizer and BioNTech have suggested that is possible, given that the vaccine can be stored for five days in a normal refrigerator.

Eventually, people will get their shots in mass vaccination centers being set up by the military at soccer stadiums and racecourses, or at doctors offices and pharmacies.

Weve been waiting and hoping for the day when the searchlights of science would pick out our invisible enemy, and give us the power to stop that enemy from making us ill, Prime Mister Boris Johnson said on Wednesday. And now the scientists have done it.

For Britain, which has suffered one of Europes highest per capita death tolls from the virus, the decision by its drug regulator was the latest evidence of a vaccination strategy that has been the most aggressive in the West.

Britain remains under the authority of the European Unions drug regulator until it consummates its split from the bloc on Dec. 31. But the government recently strengthened an old law that allows it to step out from under the blocs regulatory umbrella in public health emergencies. That allowed it to fast-track a review of the Pfizer vaccine, which was 95 percent effective in a late-stage clinical trial.

Britain had pre-ordered 40 million doses of the vaccine and 315 million doses of competing vaccines, spreading its bets to assure it can inoculate the countrys 67 million people.

British ministers cast the speed of the Pfizer approval as an early example of the new flexibility the country will have once it fully untethers itself from European regulation. Yet Brexit has also exacted costs, starving Britains drug regulator of money it used to draw from contracts with the European Union.

British regulators are also vetting a vaccine developed by the University of Oxford and AstraZeneca, a British-Swedish company. It is cheaper and easier to store than Pfizers, so much of the world could rely on it, but its regulatory path forward in the United States is unclear after scientists and industry analysts questioned promising early results.

The chemistry underlying Pfizers vaccine had never before produced an approved shot, but scientists have experimented with it for years, testing vaccines that did not make it to market. In order to coax cells to make a viral protein, called a spike, and elicit an immune response, this class of vaccine delivers genetic instructions, known as messenger RNA, encased in tiny fat globules.

BioNTech made a prophetic bet on the technology and joined forces with Pfizer, one of the worlds largest drug companies; they ended up delivering stunning results, on a timeline that was unheard-of before this year.

The U.S. Food and Drug Administration plans to decide on emergency authorization for the Pfizer vaccine shortly after a meeting of an advisory panel on Dec. 10. American officials have said vaccinations could begin within 24 hours after approval.

Another American company, Moderna, and the National Institutes of Health have also developed a messenger RNA vaccine that has proved effective in large trials. The F.D.A. will consider their application for emergency authorization shortly after Pfizers.

The European Medicines Agency, which regulates vaccines across the European Union, is expected to make a decision about the Pfizer vaccine later in December.

Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them going to the United States. Since each person needs two doses, a month apart, up to 25 million people worldwide could begin vaccination before 2021.

The United States has bought 100 million doses in advance from Pfizer, and the European Union 200 million doses.

The approval arrived at a perilous moment in the pandemic in Britain, where the virus has killed nearly 70,000 people, and hundreds more die each day. A third of Englands hospital systems were caring for more Covid-19 patients in recent weeks than at the height of the first wave in the spring.

A monthlong shutdown of restaurants and pubs has stanched the spread of the virus, but that is being replaced by a less stringent system of localized restrictions, with allowances for Christmastime travel that scientists fear will seed another uptick in infections.

In a clinical trial, the Pfizer-BioNTech vaccine proved highly effective among older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines. It caused no serious side effects.

As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of convincing people to take them. In Britain, the source of some of the most virulent modern disinformation about vaccines, just over half of people have said in surveys they would definitely accept an inoculation.

Safety concerns have been accentuated by the speed of vaccine testing and approval, despite Britains regulators saying repeatedly they were not taking shortcuts.

Beyond those challenges, manufacturers will quickly need to eventually make billions of doses and move them to hospitals, clinics and pharmacies.

The Pfizer vaccine makes this effort especially complex. It has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before injection, requiring transportation in boxes stuffed with dry ice.

Matina Stevis-Gridneff contributed reporting from Brussels, Katie Thomas from Chicago and Rebecca Robbins from Bellingham, Wash.

Read the original post:

U.K. Approves Pfizer Coronavirus Vaccine, a First in the West - The New York Times

Facebook on Thursday said it would remove posts that contain claims about Covid-19 vaccines that have been debunked by public health experts, as the social network acts more aggressively to bat down coronavirus misinformation while falsehoods run rampant.

The move goes a step beyond how Facebook had handled misinformation about other kinds of vaccines. The company had previously made it more difficult to find vaccine misinformation that was not related to the coronavirus by downranking it, essentially making it less visible in peoples news feeds.

But Facebook said it planned to take down Covid-19 vaccine falsehoods entirely if the claims had been discredited or contradicted by health groups including the World Health Organization, the United States Food and Drug Administration and the Centers for Disease Control and Prevention.

This is another way that we are applying our policy to remove misinformation about the virus that could lead to imminent physical harm, the company said in a blog post. This could include false claims about the safety, efficacy, ingredients or side effects of the vaccines.

Facebook added that it would also take down false claims that Covid-19 vaccines contain microchips, or anything else that isnt on the official vaccine ingredient list.

The social network has long been hesitant to wade into the fraught space of determining what is true or false information on its platform. Mark Zuckerberg, Facebooks founder and chief executive, has made it clear he does not want to be the arbiter of truth of what is posted on the site.

But Mr. Zuckerberg has also taken an active role in combating the spread of coronavirus misinformation. Facebook has created new products and tools to inform the public about the potential dangers of the virus. Mr. Zuckerberg emailed Dr. Anthony Fauci, the top U.S. infection disease expert, as early as March to offer his help in fighting the virus. Dr. Fauci has since appeared on multiple live-streamed interviews on Facebook with Mr. Zuckerberg.

Because of the novelty of Covid-19 vaccines, not all false claims may be taken down immediately, Facebook said. The social network said it also plans to continue sending people to its Covid-19 Information Center, which contains verified and up-to-date information about the virus.

Facebooks decision to remove vaccine-related misinformation is not without precedent. The company previously removed misinformation about the polio vaccine in Pakistan, as well as misinformation on the measles vaccine in Samoa during outbreaks of the illnesses.

More here:

Facebook says it will remove coronavirus vaccine misinformation. - The New York Times

Facebook on Thursday said it would remove posts that contain claims about Covid-19 vaccines that have been debunked by public health experts, as the social network acts more aggressively to bat down coronavirus misinformation while falsehoods run rampant.

The move goes a step beyond how Facebook had handled misinformation about other kinds of vaccines. The company had previously made it more difficult to find vaccine misinformation that was not related to the coronavirus by downranking it, essentially making it less visible in peoples news feeds.

But Facebook said it planned to take down Covid-19 vaccine falsehoods entirely if the claims had been discredited or contradicted by health groups including the World Health Organization, the United States Food and Drug Administration and the Centers for Disease Control and Prevention.

This is another way that we are applying our policy to remove misinformation about the virus that could lead to imminent physical harm, the company said in a blog post. This could include false claims about the safety, efficacy, ingredients or side effects of the vaccines.

Facebook added that it would also take down false claims that Covid-19 vaccines contain microchips, or anything else that isnt on the official vaccine ingredient list.

The social network has long been hesitant to wade into the fraught space of determining what is true or false information on its platform. Mark Zuckerberg, Facebooks founder and chief executive, has made it clear he does not want to be the arbiter of truth of what is posted on the site.

But Mr. Zuckerberg has also taken an active role in combating the spread of coronavirus misinformation. Facebook has created new products and tools to inform the public about the potential dangers of the virus. Mr. Zuckerberg emailed Dr. Anthony Fauci, the top U.S. infection disease expert, as early as March to offer his help in fighting the virus. Dr. Fauci has since appeared on multiple live-streamed interviews on Facebook with Mr. Zuckerberg.

Because of the novelty of Covid-19 vaccines, not all false claims may be taken down immediately, Facebook said. The social network said it also plans to continue sending people to its Covid-19 Information Center, which contains verified and up-to-date information about the virus.

Facebooks decision to remove vaccine-related misinformation is not without precedent. The company previously removed misinformation about the polio vaccine in Pakistan, as well as misinformation on the measles vaccine in Samoa during outbreaks of the illnesses.

More here:

Facebook says it will remove coronavirus vaccine misinformation. - The New York Times

There will be 224,250 doses of the Pfizer vaccine shipped to 109 Texas hospitals in 34 counties, according to the DSHS.

HOUSTON The Texas Health Department released more details Friday about which Texas hospitals will receive the first round of Pfizer coronavirus vaccines and how many each gets.

The first shipments of Pfizers COVID-19 vaccine are set to go out on Dec.14for healthcare workers.

There will be 224,250 doses shipped to 109 Texas hospitals in 34 counties, according to the Department of State Health Services.

What we know is vaccines will be shipped to the healthcare systems themselves, to the hospitals, so they can do what they need to do for their healthcare workers, according to Dr. Umair Shah with Harris County Public Health.

On Friday, the DSHSreleased the list of which Texas hospitals will receive the first round of vaccines and how many each will get.

Here are the Greater Houston Area hospitals and the number of doses theyll receive.

Harris County

Houston Methodist Baytown: 1,950

Memorial Hermann Cypress Hospital: 975

St. Lukes Hospital at the Vintage: 975

Texas Childrens Hospital Main: 3,900

Texas Children's Hospital West Campus: 975

HCA Houston Healthcare NW Houston: 1,950

UT MD Anderson Cancer Center: 4,875

Memorial Hermann Texas Medical Center: 5,850

Memorial Hermann Greater Heights: 1,950

Memorial Hermann SE: 1,950

Memorial Hermann Memorial City Center: 2,925

Houston Methodist Clear Lake Hospital: 975

Ben Taub General Hospital: 1,950

Houston Methodist West Hospital: 975

Houston Methodist Hospital: 5,850

Chi St Lukes Health Houston: 5,850

Houston Methodist Willowbrook: 975

Memorial Hermann Katy: 975

HCA Houston Southeast Pasadena: 975

UTMB/Clear Lake, Webster: 975

Montgomery County

Texas Children's Hospital Woodlands Conroe: 975

Houston Methodist The Woodlands Conroe: 975

Kingwood Medical Center Kingwood: 975

Memorial Hermann The Woodlands Spring: 1,950

Fort Bend County

Houston Methodist Sugar Land:1,950

Galveston County

See more here:

Here are the Houston-area hospitals that will receive the COVID-19 vaccine first - KHOU.com

LONDON Britain gave emergency authorization on Wednesday to Pfizers coronavirus vaccine, leaping ahead of the United States to become the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.

The decision cleared the way for a vaccination campaign with little precedent in modern medicine, encompassing not only ultracold dry ice but also a crusade against anti-vaccine misinformation.

Britains beating the United States to authorization on a vaccine codeveloped by an American company, no less intensified pressure on U.S. regulators, who are under fire from the White House for not moving faster to get doses to people. But it also fueled concerns that Britain was acting in haste for political reasons or trying to muscle its way to the front of the line for deliveries.

European regulators on Wednesday cast doubt on the rigor of Britains review and said that the authorization was limited to specific batches of the vaccine, a claim that Pfizer denied and British officials did not address.

Britains move provoked a spirited debate among American scientists about whether U.S. regulators, who are known to be unusually meticulous, could afford to hold off any longer on authorizing a vaccine against a virus that is claiming more than 10,000 lives a day worldwide.

American regulators have argued that they lag behind if only by a matter of days because they are virtually alone in reanalyzing thousands of pages of raw data from vaccine trials before approval. Backers of that approach say it is the only way to minimize unintended damage, in lives and in public trust, from vaccines not working.

British and European regulators lean more heavily on the companies own analyses, auditing their figures occasionally but otherwise grounding their decisions on vaccine makers reports. While the more cautious American approach can be valuable, some scientists said the Europeans subject vaccine makers to considerable scrutiny, and it is imperative to move quickly to curb the suffering wrought by the pandemic.

When you say its OK to wait another week or two, youre saying its OK that many thousands of people are going to die, said Dr. Walid F. Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

No country until Wednesday had authorized a fully tested coronavirus vaccine; Russia and China approved vaccines without waiting for large-scale efficacy tests.

The British government, battered by its handling of the pandemic, exulted in the authorization.

Help is on its way with this vaccine and we can now say that with certainty, rather than with all the caveats, the British health secretary, Matt Hancock, said Wednesday.

While the go-ahead bodes well for Britain, which broke from the European Unions regulatory orbit to approve the vaccine early, it will have no effect on the distribution of the hundreds of millions of doses that the United States and other wealthy countries have procured in prepaid contracts.

It also offers little relief to poorer countries that could not afford to buy supplies in advance and may struggle to pay for both the vaccines and the exceptional demands of distributing them.

Roughly 800,000 doses of the Pfizer vaccine, developed with BioNTech, a smaller German firm, were being packaged at the companys Belgian manufacturing plant on Wednesday for shipment to Britain. How and when they will arrive is a secret for security reasons, the company said.

The complicated logistics of moving, defrosting and preparing the vaccine meant it was going to be given only at 50 British hospitals to begin with. The vaccine must be transported at South Pole-like temperatures, and in trays of 975 doses.

First to be vaccinated will be doctors and nurses in the countrys National Health Service, along with nursing home workers and people 80 and over with previously scheduled doctors appointments. A government advisory committee has suggested that older or more vulnerable health workers, and doctors and nurses who work with fragile patients, would be among the first in line.

But the government has not said when other employees of the National Health Service would be eligible for vaccines. Essential workers, like teachers, transport workers and first responders, would not be vaccinated until after people 50 and over and those with underlying health problems received shots.

The advisory committee plans had made nursing home residents a top priority, but they will have to wait until the government begins distributing vaccines beyond hospitals. Pfizer and BioNTech have suggested that is possible, given that the vaccine can be stored for five days in a normal refrigerator.

Eventually, people will get their shots in mass vaccination centers being set up by the military at soccer stadiums and racecourses, or at doctors offices and pharmacies.

Weve been waiting and hoping for the day when the searchlights of science would pick out our invisible enemy, and give us the power to stop that enemy from making us ill, Prime Mister Boris Johnson said on Wednesday. And now the scientists have done it.

For Britain, which has suffered one of Europes highest per capita death tolls from the virus, the decision by its drug regulator was the latest evidence of a vaccination strategy that has been the most aggressive in the West.

Britain remains under the authority of the European Unions drug regulator until it consummates its split from the bloc on Dec. 31. But the government recently strengthened an old law that allows it to step out from under the blocs regulatory umbrella in public health emergencies. That allowed it to fast-track a review of the Pfizer vaccine, which was 95 percent effective in a late-stage clinical trial.

Britain had pre-ordered 40 million doses of the vaccine and 315 million doses of competing vaccines, spreading its bets to assure it can inoculate the countrys 67 million people.

British ministers cast the speed of the Pfizer approval as an early example of the new flexibility the country will have once it fully untethers itself from European regulation. Yet Brexit has also exacted costs, starving Britains drug regulator of money it used to draw from contracts with the European Union.

British regulators are also vetting a vaccine developed by the University of Oxford and AstraZeneca, a British-Swedish company. It is cheaper and easier to store than Pfizers, so much of the world could rely on it, but its regulatory path forward in the United States is unclear after scientists and industry analysts questioned promising early results.

The chemistry underlying Pfizers vaccine had never before produced an approved shot, but scientists have experimented with it for years, testing vaccines that did not make it to market. In order to coax cells to make a viral protein, called a spike, and elicit an immune response, this class of vaccine delivers genetic instructions, known as messenger RNA, encased in tiny fat globules.

BioNTech made a prophetic bet on the technology and joined forces with Pfizer, one of the worlds largest drug companies; they ended up delivering stunning results, on a timeline that was unheard-of before this year.

The U.S. Food and Drug Administration plans to decide on emergency authorization for the Pfizer vaccine shortly after a meeting of an advisory panel on Dec. 10. American officials have said vaccinations could begin within 24 hours after approval.

Another American company, Moderna, and the National Institutes of Health have also developed a messenger RNA vaccine that has proved effective in large trials. The F.D.A. will consider their application for emergency authorization shortly after Pfizers.

The European Medicines Agency, which regulates vaccines across the European Union, is expected to make a decision about the Pfizer vaccine later in December.

Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them going to the United States. Since each person needs two doses, a month apart, up to 25 million people worldwide could begin vaccination before 2021.

The United States has bought 100 million doses in advance from Pfizer, and the European Union 200 million doses.

The approval arrived at a perilous moment in the pandemic in Britain, where the virus has killed nearly 70,000 people, and hundreds more die each day. A third of Englands hospital systems were caring for more Covid-19 patients in recent weeks than at the height of the first wave in the spring.

A monthlong shutdown of restaurants and pubs has stanched the spread of the virus, but that is being replaced by a less stringent system of localized restrictions, with allowances for Christmastime travel that scientists fear will seed another uptick in infections.

In a clinical trial, the Pfizer-BioNTech vaccine proved highly effective among older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines. It caused no serious side effects.

As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of convincing people to take them. In Britain, the source of some of the most virulent modern disinformation about vaccines, just over half of people have said in surveys they would definitely accept an inoculation.

Safety concerns have been accentuated by the speed of vaccine testing and approval, despite Britains regulators saying repeatedly they were not taking shortcuts.

Beyond those challenges, manufacturers will quickly need to eventually make billions of doses and move them to hospitals, clinics and pharmacies.

The Pfizer vaccine makes this effort especially complex. It has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before injection, requiring transportation in boxes stuffed with dry ice.

Matina Stevis-Gridneff contributed reporting from Brussels, Katie Thomas from Chicago and Rebecca Robbins from Bellingham, Wash.

Visit link:

U.K. Approves Pfizer Coronavirus Vaccine, a First in the West - The New York Times

Coronavirus vaccines are just around the corner, but most people probably won't be able to get them until well into 2021.

Huge developments in the effort to create a COVID-19 vaccine mean the first group of people is on track to receive vaccinations against the coronavirus before the end of the year. On Wednesday, the UK approved Pfizer's vaccination for use, and the US is expected to follow suit. Modernahas also sought emergency FDA approval for its first doses of a similar type of vaccine.

The question is, who will get those first doses of vaccines and how long will you yourself have to wait to get vaccinated? Despitegovernment efforts to beef up the supplyof vaccine doses, simple math shows the size of the challenge. There areover 330 million peoplein the US, butPfizersays it expects to send the US 25 million doses, or enough to vaccinate about 12.5 million Americans, by the end of 2020 (two per person because you'll need a booster shot). That's roughly the populations of New York City and Los Angeles combined.

Keep track of the coronavirus pandemic.

Moderna says it will be able to make about 15 million vaccine doses at first, which can treat 7.5 million people (again, a series of two shots per person). The unfortunate reality is that most people in the USwill have to wait several monthsat least before they might have access to a coronavirus vaccine. Worse still, it could be a matter of years before everyone in the world can get vaccinated against COVID-19.

The answers as to who gets a priority immunization are becoming a little less hazy, but they're far from definitive. Here's what we know of the coronavirus vaccine rollout so far, as well as where you might fall in the priority list. And here's how much you might expect to pay for your COVID-19 vaccine.

This article was updated recently with new information, and is intended to be a general overview and not a source of medical advice.

Even after coronavirus vaccines are authorized, people will have to continue wearing masks and taking other preventative measures for months to come.

Frontline health care workers who are particularly at risk of being exposed to coronavirus -- likeroughly 20 millionUS doctors, nurses, lab technicians, EMT and hospital staff -- have long been at the top of the US priority list. Now that's nearly official.

An independent advisory panel that reports to the Centers for Disease Control and Prevention officially recommended on Dec. 1 that medical and emergency workers who are at the highest extended daily risk of acquiring COVID-19 should be first in line for a vaccine.

The panel also recommended that employees and residents of long-term care facilities -- more or less, nursing homes -- should also be part of the first batch of inoculations.

The director of the CDC, Dr. Robert Redfield, could decide as soon as this week whether to adopt the Advisory Committee on Immunization Practices' decision as the agency's formal guidance. Ultimately, the decision on who gets first dibs on a COVID-19 vaccine belongs to state governors in consultation with their own public health experts, but states typically follow CDC guidelines, the New York Times reported.

Life probably won't be back to normal until late 2021 or 2022 at the earliest, which could mean regular temperature checks until the coronavirus is no longer a threat.

When the CDC advisory panel, ACIP, met last month in preparation for this week's vote, it identified a handful of other groups that committee members believed should get priority access to coronavirus vaccines while supplies remain limited.

Essential workers:Approximately87 million US workersprovide the basic goods and services we need to survive. Most can't work from home and many jobs require interacting with the public, so guarding against COVID-19 among this population would have a ripple effect across the whole country while also reducing critical service interruptions.

People with underlying medical conditions:Specifically, the100 million or so peoplewith conditions putting them at high risk for illness or death from COVID-19. Any disease affecting the lungs, but also anything that could compromise a person's immune system, like cancer or HIV, would be included.

Older adults: It's widely accepted that risk of severe complications from COVID-19 increases with age. The ACIP recommends theapproximately 53 millionUS adults age 65 and over be among the first to get vaccinated.

Some vaccines will require more than one dose to be effective.

The reality is that you should expect to wait. The top US infectious disease expert, Dr. Anthony Fauci,told Good Morning Americain November that he expects "the ordinary citizen" should be able to get a vaccine by April, May or June 2021.

In the interim, you're still expected to adhere to pandemic safety practices like universal masking, avoiding crowds, maintaining social distancing and washing our hands even more than usual. That includes everyone; vaccinated and nonvaccinated alike (keep reading for more on what to expect).

Short answer: The first vaccine is expected soon and it looks like there will be more than one safe, effective type. Pfizer, which says its vaccine candidate is 95% effective at preventing coronavirus infections, is expected to produce the first COVID-19 vaccine to receive Food and Drug Administration authorization in the coming weeks. The company has already started shipping doses across the US.

Moderna isn't far behind with its reportedly 94% effective vaccine. Moderna is expected to receive FDA authorization sometime in December as well. Other vaccines from AstraZeneca and Johnson & Johnson are wrapping up late-stage trials, as well, while a fifth manufacturer, Novavax, is set to begin the final trial for its vaccine sometime this year.

Thegeneral consensus has been -- andcontinues to be -- that although the first COVID-19 vaccines will probably be approved in the US in a matter of days and weeks, they won't reach widespread distribution untilsometime in 2021. Until then, supplies are expected to be limited, which is partially why we will need multiple vaccines so that as many people can be treated as possible.

Normal life probably won't resume for a while, which could mean no sitting in waiting rooms until the coronavirus is no longer a threat.

"[The government] has plans to distribute vaccines within 24 hours after the ACIP gives its final approval," Paul Mango, a US Department of Health and Human Services official,told reporters in October, referring to the CDC's Advisory Committee on Immunization Practices, which is the group that officially sets national guidelines for who should get vaccines once they've been authorized by the FDA.

Infection rates in the US are skyrocketing, with the seven-day rolling average nowover 150,000 new infections per day. Much of Europe has been locked down since early November. One of the key advisors on President-elect Joe Biden's COVID-19 task force, Dr. Michael Osterholm, has recommended a nationwide lockdown in the US for four to six weeks to help contain the rapidly spreading virus, although President Donald Trump said in November there would be no lockdown under his administration.

In other words, we're not out of the woods yet, especially as we get closer to winter, when coronavirus-related deaths are expected to continue surging. Experts agree that people who leave their households will need to continue to wear masks, avoid crowds, maintain social distancing and practice regular hand-washing until further notice.

Unfortunately, coronavirus vaccines aren't as simple as just taking a few pills.

Prior to 2009, older adults and patients with underlying health conditions typically topped lists of those who should get first dibs on a new vaccine because, for them, getting sick was more likely to be fatal. However, that line of reasoning began to shift after a2009 paper published in the journal Science suggested that health officials dealing with a limited vaccine supply could prevent far more people from getting sick and dying by vaccinating those who were most likely to transmit a given disease, rather than those at risk of getting the sickest.

That paper specifically addressed H1N1 -- aka the swine flu -- and generally dealt with seasonal influenza. In it, researchers identified the biggest demographic of flu spreaders as children aged 5 through 19. That'swhy the CDC now advises everyone aged 6 months and older to get a yearly flu vaccine. In the case of COVID-19, experts have identified health care workers on the front lines as the group most likely to catch and therefore spread the disease, which is why they will be among the first to receive vaccinations.

Whether or not COVID-19 vaccines are effective at stopping the spread of the coronavirus will depend a lot on how our bodies build immunity to the disease. Here's what we know so far about whether you can get COVID-19 more than once. Testing is also key to slowing the coronavirus' spread -- learn about a device that can produce COVID-19 test results in under 90 minutes. And read up on how all of these issues and more affectBiden's plan to fight COVID-19.

Now playing: Watch this: Will a COVID-19 vaccine be a triumph of science or soul-searching?

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The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

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Who gets the COVID vaccine first? CDC priority and everything else we know - CNET

Bill Lang didnt get much of a break over Thanksgiving. Almost every day last week, the medical director at a high-end concierge medical practice, WorldClinic, heard from clients asking when a Covid-19 vaccine would be available.

Two patients even texted on Thanksgiving day. Since then, Ive had at least three texts or calls every day just asking, When do you think I can get a vaccine? said Lang, who is based in Washington, but also speaks with patients across the U.S. and internationally.

Athletes, politicians, and other wealthy or well-connected people have managed to get special treatment throughout the pandemic, including preferential access to testing and unapproved therapies. Early access to coronavirus vaccines is likely to be no different, medical experts and ethicists told STAT. It could happen in any number of ways, they said: fudging the definition of essential workers or high-risk conditions, lobbying by influential industries, physicians caving to pressure to keep their patients happy, and even through outright bribery or theft.

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The worst attempts to nefariously procure a vaccine may come a few months into distribution, once vaccines are available that dont require ultra-cold storage and local pharmacies and physician practices get allotments. There absolutely will be a black market, said bioethicist Arthur Caplan of New York University. Anything thats seen as lifesaving, life-preserving, and thats in short supply creates black markets.

At WorldClinic, which charges members $10,000 to $250,000 a year for 24/7 care, no patients have asked for special treatment and the clinic would not undermine its integrity by trying to secure vaccines unethically, said Lang, who was a White House physician during both the Bush and Clinton administrations. The optics of trying to jump the line would be so bad, they dont want to do that. But within the broader system, he added, some people will inevitably cut in line.

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Essential workers are expected to receive early access to the vaccine, and the definition of this category is open to interpretation by state health departments, creating a means for influential industries to lobby for priority. The devils going to be in the details of how the state runs their program, Lang said he tells his patients.

Members of the Advisory Committee on Immunization Practices (ACIP), the federal panel recommending how to distribute the vaccines, want to prioritize essential workers to help ensure people of color, who are often the hardest hit by the virus, get early access. But the predominantly white workers in the financial services industry are also considered essential, according to guidance from the Cybersecurity and Infrastructure Security Agency, which was referenced by ACIP, as well as executive orders from several states including New York, Illinois, Colorado, and California. Public-facing bank tellers face contagion risks in their work, but arent the only financial services employees included.

It was left a little bit nebulous but basically covered people who oil the movement of money, so exchanges, trading floors, trading operations, and people who keep money moving at the retail [banking] level, said Lang. Theyre defined very broadly in New York and Illinois, because thats where so many of our financial services industries are based.

The concept of essential workers has already been tested during the pandemic, when Florida declared that World Wrestling Entertainment (WWE) met the definition and could remain open during lockdown. The chairman of WWE, Vince McMahon, is friends with President Trump, while his wife, Linda McMahon, served in the administration and is chair of a pro-Trump super PAC. Neither WWE nor Floridas health department responded to requests for comment about whether WWE would be considered essential for the vaccine rollout.

Other powerful industries might be tempted to follow this example. The potential of industry lobbyists redefining what an essential worker is is a very strong possibility, said Glenn Ellis, a visiting scholar at the National Center for Bioethics in Research and Health care at Tuskegee University and a narrative bioethics fellow at Harvard Medical School.

Prioritizing essential workers is intended to give early vaccine access to those who provide a critical societal function and cannot socially distance easily, the Colorado health department said in a statement that acknowledged it can be difficult to write airtight rules. Given the thousands of different job descriptions in the state, it is impossible to come up with a complete list for every occupation for a specific vaccine phase. Vaccine providers will need to use their best judgment about which patients may qualify for vaccination during this phase.

The California health department confirmed financial services employees, including those needed to maintain orderly market operations, will have early access to the vaccine as essential workers, as will people in the news media, such as reporters. State health departments in New York and Illinois did not respond to requests for comment about whether those in financial services would receive a vaccine early.

Another opening that could be exploited to skip the line involves high-risk medical conditions that warrant early access to the vaccine. Smokers are within this group, according to ACIP, and people with conditions such as moderate-to-severe asthma and high blood pressure could also be included.

This leaves room for a doctor to, for example, portray a patients mild asthma as severe enough to justify early access to a vaccine, said Jonathan Cushing, head of major projects of the health initiative at Transparency International, a nonprofit focused on global corruption. The profit motives within U.S. health care make it particularly susceptible to such distortions, he said: Its a market-based economy. You as a doctor want to keep your clients coming back.

Given the need to protect patient privacy, Lang said he doesnt expect immunization sites to demand documentation of health risk factors. Instead, they will likely either ask patients to state that they have one of the relevant conditions, without disclosing details, or require physician certification, he said: A lot of that is left to a doctors judgment.

Exaggerating sickness is not a new phenomenon in the U.S. medical system. Insurance companies have portrayed Medicare patients as sicker than they really are, so as to receive higher government payouts. Similarly, physicians to wealthy patients could make sure theyre among the first to get the vaccines by fudging it in a way that would enable their clients to cut in line said Wendell Potter, former head of corporate communications at Cigna and current head of the nonprofit Center for Health and Democracy.

The U.S. health care system is generally designed to give preferential treatment to those with wealth and connections, ethicists said. When we talk about the concept of individuals being able to get to the front of the line, thats not difficult, because our system is designed to advantage those people with means like that, said Tuskegees Ellis. They dont have to really do anything sinister. All they have to do is access the system that they are a part of.

Powerful companies can leverage their connections with insurance companies to get access to shots quickly, for example. Some of the richest investment firms have their own mini health systems, so they can run vaccines through those doctors that give the physicals and maintain the health of the executives in the company, said NYUs Caplan.

GPS tracking on vaccine shipments will make it harder to pilfer shots en route, though not impossible. I have a lot of respect for the creativity of criminals, said Alison Bateman-House, a bioethicist at New York University Grossman School of Medicine. If someone can see a way to make good money off of driving a pallet of vaccines off in a forklift, Im sure somebody will figure out how to do it.

But bioethicists believe pharmacies, urgent care clinics, and doctors offices are among the most vulnerable points along the distribution chain. The state-line divides within the health care system make it especially vulnerable to abuse. Theres far less scrutiny of state legislative and regulatory bodies than at the federal level, said Potter. The fragmentation makes gaming the system easier and more likely.

Vaccine administration sites are subject to less scrutiny than vaccine shipments, agreed Hani Mahmassani, the director of the Northwestern University Transportation Center. Once this product is in the hands of the entities that are responsible for vaccination, and thats going to be your, sort of, your local entities, really, anything could happen. Vaccine administrators who accept bribes could face serious deterrents potentially including prosecution, he said, but the possibility cant be ruled out.

The supply of a high-demand, life-altering vaccine will never be completely protected from abuse.

Will there be people who do break the line? Yes, said Lang. Will family members of Congress somehow get immunized a little bit early? Who knows.

At a certain point, though, vigilance brings its own risks. If you add too many inefficiencies of checking and double-checking everyone, then you put so much bureaucracy into the program, you slow things down, he added.

The public shame of being caught should act as a deterrent, especially if the backlash is akin to what several Hollywood celebrities and wealthy parents faced following the 2019 college admissions bribing and cheating scandal, said Bateman-House.

I can promise you, no CEO wants to be on the front page of the newspaper for giving preferential access to his college roommate, she said. I think a few public naming and shamings would probably tamp down some activity.

Instilling a sense of public responsibility and solidarity is another way to deter malfeasance, said Cushing, though this is easier in theory than practice. Otherwise, he said, vaccine delivery should be clearly and transparently tracked, and there should be reporting mechanisms to flag abuse, ideally with state hotlines specifically focused on vaccine line-cutting.

Several bioethicists warned that the number of high-profile politicians, including President Trump, Chris Christie, and Ben Carson, who received early access to experimental Covid-19 treatments set a dangerous precedent. When that occurred, the general consensus, Caplan said, was a wink and a blink and a, Well, thats the way it is.

Following the vaccine rollout, the response to the wealthy and powerful cutting the line needs to be different and fierce, he said. Everybody has to condemn them: the media, your neighbor, your boss, everybody.

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How the rich and privileged can skip the line for Covid-19 vaccines - STAT

In Britain, the first shots will go to nursing home patients and those who care for them, followed by everyone over 80 and health care workers. From there, the program will be expanded as the supply increases, with the vaccine offered roughly on the basis of age groups, starting with the oldest people.

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Britain approves vaccine and will begin shots within days - The Philadelphia Inquirer