The CDC's Advisory Committee on Immunization Practices met to discuss whether to recommend use of any Covid-19 vaccine that the US Food and Drug Administration might authorize.
Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated, and members of the ACIP -- as well as liaison representatives who take part in the discussion -- said that could affect people's willingness to get vaccinated in the first place, or to get the second dose of the two-vaccine regimen.
"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr. Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.
"They are going to know they got a vaccine. They are not going to feel wonderful."
The whole point of vaccination is to cause an immune response in the body and that can sometimes cause flu-like symptoms such as body aches, or even fever and a headache.
Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, representing the National Association of Pediatric Nurse Practitioners, said providers must be ready to explain this to people getting any vaccine.
"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Stinchfield told the meeting. Some people may feel bad enough to need to stay home from work for a day, she said.
Dr. Paul Hunter of the city of Milwaukee health department and a voting member of the committee, said it will be important for the first people to get vaccinated to describe these experiences to others.
Boosting confidence in a vaccine
"The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them, because they are going to let us know how it feels," he said. "And I think these people are likely to be health care workers who are likely to be up for that kind of task."
Public willingness to get a coronavirus vaccine has been steadily dropping since the spring, but it might improve when people start to hear more about the safety and efficacy of the various vaccines in the works, the CDC's Dr. Sara Oliver told the committee during the five-hour-long meeting.
Oliver said the CDC has been looking at various surveys on attitudes and noted that anywhere between 40% and 80% of those surveyed said they'd be willing to get vaccinated.
"Many adults reported intentions to receive Covid vaccine. But concerns were raised around side-effects, unknown efficacy and the speed of the (authorization) process," Oliver told the meeting.
Vaccine acceptance was highest among Asian-Americans and lowest among African-Americans, Oliver said. That's of concern because ACIP wants to make sure any vaccine that is approved gets to the groups most affected by the pandemic, and Blacks are among the hardest hit by Covid-19.
Nurses were also a concern. One survey showed that while nurses agreed vaccines were likely to be safe and effective, only 34% would voluntarily get vaccinated, Oliver said.
Members of ACIP said they thought these fears could be addressed with education campaigns and as people learned about data showing that, for example, the Pfizer and Moderna vaccines were about 95% effective in preventing symptomatic disease with no significant safety concerns.
Allocating the vaccine
Fair access is at the top of the list, ACIP committee members said in a document published at the start of the meeting.
"How do characteristics of the vaccine and logistical considerations affect fair access for all persons?" they asked in the document, released in the CDC's MMWR report.
"Does allocation planning include input from groups who are disproportionately affected by Covid-19 or face health inequities resulting from social determinants of health, such as income and health care access?"
The CDC, the National Academies of Science, Engineering and Medicine and other advisers have proposed four groups that should get vaccinated first: health care personnel, other essential workers, adults with high risk medical conditions and other adults 65 and older.
That's a lot of people. The CDC estimates there are 21 million healthcare personnel, 87 million essential workers, 100 million adults with high risk medical conditions and 53 million others are 65 and older. The federal government has said 40 million coronavirus vaccine doses could be available by the end of December.
There's little disagreement that frontline healthcare workers should be in the first group -- designated as 1a. At issue is whether residents of long term care facilities should be in this group, also.
There's no question it's a highly vulnerable population. "Long term care facility residents and staff accounted for 6% of cases and 39% of deaths in the US, despite the fact that long term care facility residents account for less than 1% of the US population," the CDC's Dr. Kathleen Dooling told the meeting.
Plus, it's a group that would be easier to reach if the staff caring for them are already being immunized in the first phase of any vaccine that might get emergency authorization from the FDA.
But ACIP member Dr. Helen Keipp Talbot worried that this frail group might do poorly in general and damage faith in the vaccine.
"There is such a high mortality rate in long term care facilities," Talbot told the meeting. "There will be a number of patients who receive immunizations for Covid and will pass away. And it will be regardless of the vaccine and most likely will be regardless of the vaccine," Talbot said.
"But early on as we're building confidence and we will not be able to show any data to say that it was not due to the vaccine because there's not been a randomized, controlled trial. And I think we're going to have a very striking backlash of 'my grandmother got the vaccine and she passed away,' and they're not likely to be related, but that will become remembered and break some of the confidence in the vaccine."
But others did not think that putting these residents further back in line would help.
Hunter said it would be inefficient to vaccinate healthcare workers in the facilities but skip residents. "Why not vaccinate people that, you know, you, you've got it all set up and ready to go?" he asked. "It's an efficiency to vaccinate a bunch of people who could benefit from it."
AstraZenecas COVID-19 vaccine is up to 90% effective, the company said Monday in a press release, making it the third pharmaceutical firm to report promising vaccine news, following Pfizer and Moderna. AstraZeneca, which partnered with University of Oxford researchers to develop its two-dose vaccine, reported efficacy from two different dosing regimens; one led to 62% efficacy and another to 90%, with an average, the company says, of 70%.
The companys vaccine was initially developed by Oxford scientists, who started with a disabled cold virus that commonly infects chimpanzees. Its a more traditional approach than the strategy used by Moderna and Pfizer, both of which relied on the genetic mRNA code from SARS-CoV-2, the virus that causes COVID-19. The Oxford team used the cold virus as a molecular Trojan horse (technically known as a vector) to disguise the true payload: material from SARS-CoV-2, which triggers the human immune system into action. The chimp virus helps to deliver the coronavirus more efficiently without causing actual COVID-19.
Among people who received a half dose of the AstraZeneca vaccine, and then a full dose about a month later, about 90% were protected from symptomatic COVID-19 illness. Among those getting two full doses of vaccine a month apart, 62% were protected from getting sick. None of the people receiving either regimen were hospitalized or became severely ill.
The data, part of a scheduled efficacy review, are based on 131 cases of COVID-19 among both the vaccinated and placebo groups. But because the full set of data has not been published, vaccine expertsincluding regulatorsare still trying to figure out why the different regimens led to different results. The different levels of efficacy with two different dosing regimens is scientifically intriguing, says Dr. Jessica Justman, associate professor of medicine in epidemiology at Columbia Mailman School of Public Health and senior technical director of ICAP at Columbia, a global public health services group.
One possible explanation relates to the vaccines design. Because it relies on a weakened cold virus to deliver the COVID-19 viral material, recipients immune systems may actually be mounting a response to the cold virus rather than the coronavirus. Halving the first dose helps to dampen this immune response to the cold virus, possibly increasing the response to the coronavirus.
We know with other [cold] virus vectors you do get immunity to the vector, says Dr. Anna Durbin, professor of international health at Johns Hopkins University and an investigator running one of the U.S. COVID-19 vaccine trials. It may be that the higher [first] dose induced more immunity against the vector so when the second dose came in, it didnt express the [SARS-CoV-2] protein as well. But we dont know that yet.
Its also possible that the discordant results have something to do with the way the trials were conducted. Testing of the half dose+full dose regimen, which was done in the U.K., began after the companys combined U.K.-Brazil trials had started and many participants already received the originally planned two full doses. Fewer people received the former combinationnearly 9,000 people received two full doses, while only 2,700 received the half dose+full dose regimen. Those in the latter group have been followed for a shorter period of time, and simply may not have had enough time to develop COVID-19.
In the U.S. trials, however, all participants are still receiving two full doses of vaccine. Results from those tests could help to explain some of the discrepancy. I will be very interested to see if we are going to see the same results or different results from the [U.S.] trial, Durbin says. She also notes that it would be challenging to change the U.S. trials at this point to include a half-dose+full dose regimenthe vaccine trial design was vetted and approved before they began, and modifying them would potentially compromise the data, as scientists would no longer be comparing similar groups of people across different sites.
The U.K. and Brazil data also suggest that the AstraZeneca vaccine may be helping to prevent transmission of the virus. If true, that would be an added bonus, says Durbin. However, the company did not say how many of the 131 confirmed COVID-19 cases among trial participants tested positive but experienced no symptoms. In the U.K. and Brazil studies, the researchers tested volunteers weekly, so they could understand how many people developed asymptomatic disease, and study them for their response to the vaccine. In the U.S. study, people are only tested if they develop COVID-19 symptoms, meaning that among those who are positive, researchers are comparing how sick the vaccinated people get to how ill those receiving placebo get.
All of which means that the AstraZeneca results, while encouraging, leave a lot of unanswered questions. Its not clear how the U.S. Food and Drug Administration (FDA) will interpret the data, and whether it will recommend the half dose+full dose regimen, or require more data to be collected about that approach.
One factor that may play a role: with infections continuing to rise around the world, its becoming critical to vaccinate as many people as possible, as quickly as possible. And if the half dose+full dose regimen proves more effective when the final data are revealed, then it also has the advantage of immunizing more people with the same amount of vaccine. Its a win-win, says Justman. You get better protection and provide it to more people.
But its still too early to tell whether thats the case, and also too early to start making decisions about which vaccine you might choose if given the option. The advice I would give today, on Nov. 23, is to sit back and wait and see what additional information comes out, says Justman. As much as we want all the information right now, I think we need to just be patient and let things play out through proper scientific and regulatory channels.
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Pfizer and Moderna have both announced promising results in the phase 3 trials of their COVID-19 vaccines. Here's how they differ. Storyful
The success of two COVID-19 candidate vaccines marks a turning point in the long history of vaccinesand could lead to major advances against a variety of diseases.
Vaccines developed by Pfizer/BioNTech and Moderna are more than 95% effective against COVID-19, trials show. Both depend on a technology never before used in a commercial vaccine that could upend the way future ones are made.
This new messenger RNA technology, as well another method that depends on viruses to deliver vaccines, are transforming the field, said Brendan Wren,a professor of vaccinology at the London School of Hygiene and Tropical Medicine.
"It could be quite a new era for vaccines and vaccinology," he said. "We seemed to move ahead in this one year 10 years."
These technologies had advanced enough that they were ready in time for this years burst of COVID-19-related funding and attention to be proved in human trials.
Its a silver lining of sorts to the pandemic. Without the urgency to find a solution to COVID-19, the money and the collaboration between government, academia and industry required for the breakthrough might not have come together for years, if ever.
"COVID is what made RNA jump to the head of the pack," said Dr. Drew Weissman, a professor of medicine at the University of Pennsylvania's Perelman School of Medicine.
Though messenger RNA technology hasn't grabbed headlines before now, a handful of researchers, including Weissman, have been working on it for decades.
"Actually, it feels like my entire life," said Weissman, who helped launch and lead the field since the 1980s.
Messenger RNAsare part of the body's toolkit used to turn a DNA blueprint into the proteins needed for every cellular activity. Weissman and other researchers tried for years toget the technology to work, butevery time they injected an experimental mRNA vaccine into an animal, it triggered dangerous inflammation.
However, advances in the science some credited to Weissman and his academic colleagues, others to government scientists or those in private industry have finally brought mRNA vaccines to the finish line.
The success serves as a reminder of the importance of basic science, said Dr. Barney Graham, a government researcher whose office has been collaborating with Moderna for nearly four years to advance their mRNA vaccine technology.
"Investment in basic science only helps," Graham said. "Even if it looks like some arcane idea that doesn't make sense, that kind of knowledge and basic understanding of biology and how things work are really informative to this kind of program."
AstraZeneca: COVID-19 vaccine candidate developed by Oxford 'highly effective' in trials
USA TODAY vaccine panel: 'Best news so far' in COVID-19 fight, but logistical challenges remain
The success of the companies' mRNA vaccines proves the technology is sound.Pfizer's completed trial of 44,000 people and Moderna's nearly finished trial of 30,000found the approach to be safe, causing no major health issues, and effective, protecting more than 95% of those vaccinated.
"All the boxes have now been checked. The platform clearly works," Anthony Fauci,head of the National Institute of Allergy and Infectious Diseases, said in a news conference announcing Moderna's effectiveness results.
He said he would have been satisfied had the mRNA vaccines been 70%-75% effective.
"Our aspirations have been met, and that's really very good news," Fauci said. "Help is on the way."
Messenger RNAs (in pink)turn a DNA blueprint into the proteins needed for every cellular activity.(Photo: Getty Images)
Advocates say messenger RNA vaccines have several advantages over traditional technologies.
They aren't grown in eggs or cells and don't have to go through the arduous purification of most vaccines, said Graham,deputy director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
"The more you can simplify things and just use exactly what you need and not anything more, overall it makes products safer and more likely to work," he said.
The mRNA vaccines can be developed quickly.
Moderna was ready to test its mRNA-1273 candidate vaccine in people about two months after receiving the genetic code of the virusfrom Chinese scientists. That's orders of magnitude faster than any vaccine ever before.
Infected again or endless COVID-19? How the 'reinfection phenomenon' could impact vaccines, herd immunity and human behavior
In clinical trials, the mRNA vaccines caused temporary side effects in 80%-90% of trial participants, but they were mild:Most had sore arms or felt cruddy for a day or two. No one fell seriously ill. Though that could change when vaccines are given to billions of people, the early results suggestbad reactions will be rare.
Messenger RNA vaccines contain only a fraction of the virus, so unlike some vaccines, they can't give people the disease they're trying to preventor trigger allergies to eggs or other traditional vaccine ingredients.
Most of the COVID-19 vaccines under development introduce copies of the same "spike" protein found on the surface of the virus that causes COVID-19. They train the immune system to recognize this protein and attack in case of infection.The mRNA vaccines direct the machinery of human cells to manufacture that spike protein.
The downside ismRNA molecules are fragile. To keep them from falling apart, researchers spent years figuring out how to encase the mRNAs in tiny droplets of fat.
In Pfizer/BioNTech's vaccine, that fat has to stay at super-cold temperatures, so it maintains its shape and shields the mRNA.
Moderna figured out how to maintain droplets for longer at warmer temperatures, so its vaccine needs to be stored at only normal freezing temperatures, or for up to a month in a fridge.
The fat droplet boosts the effectiveness of the vaccine, turning more cells into spike-protein-producing machines, Weissman said, which may be why they proved so effective against COVID-19.
"I am incredibly enthusiastic about these results," he said.
Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY
It took years of work for Weissmanand a Penn colleague, Katalin Karik,tofind that if they swapped out one of the building blocks of RNA called a nucleoside not only would they solve their inflammation problem, the mRNA would make much more of the desired protein.
"We thought at that point it would be a great therapeutic," said Weissman, whose research is funded by BioNTech.
Weissman andKarik used their modified mRNA to make a hormone callederythropoietin, the absence of which causes a lack of red blood cells, leading to anemia.
"It worked beautifully," Weissman said. So far, the results are confined to a lab dish, mice and macaque monkeys. Someday, he hopes to test similar approaches against diseases in people.
In their lab, Weissman and his colleaguestested experimental vaccines against about 30 diseases. "It's looked great in just about all," he said.
COVID-19 vaccines are almost ready to be distributed:Who gets them after health care workers? Here's a list
Experimental mRNA vaccines have protected mice and ferrets against all types of flu. They appeared effective against genital herpes and malaria. They produced proteins that have gone missing in a wide variety of diseases, such as cystic fibrosis.
In addition to tackling COVID-19, Moderna has been developing mRNA vaccines against infectious diseases such asZika and chikungunya, as well as others to fight cancer.
Now that COVID-19 vaccines have proved the mRNA approach can work, there should be much more enthusiasm and money to pursue other mRNA vaccines and therapies.
"The potential is just enormous," Weissman said.
Katelyn Evans, 16, gets the first of two shots as part of a trial testing of Pfizer's COVID-19 vaccine in minors.(Photo: Cincinnati Children's Hospital)
Over the next few years, he and other scientists will work to reduce side effects from mRNA vaccines and therapies, while making them cheaper to manufacture, more stable at warmer temperatures and more potent so they can hopefully be given in one dose, instead of the two shots needed against COVID-19.
"My expectation is that those practical aspects, such as the temperature storage and stability over time at different temperatures, will continue to improve moving forward," said Dr. Dan Barouch,a professor of medicine at Harvard Medical Schooland director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, both in Boston.
Barouch and others dream of a vaccine that could be dispatched within a few months of a new outbreak.
"This (pandemic)would have evolved very differently if we had been able to immunize back in March," noted Dr. Bruce Walker,who directs the Ragon Institute of MGH, MIT and Harvard, which focuses on immunology and vaccine development.
"As we get more experience with these vaccines and as we learn from this pandemic how to actually scale up rapidly," he said, "I think more and more time can be shaved off."
A year ago, people would have said getting a vaccine developed and ready for the public within a year would be impossible. But two COVID-19 vaccines are likely to receive federal approval next month, and several more arent far behind.
"We've shown that's possible," Walker said. "And now we have to set our aspirations even higher."
Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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The mRNA vaccines do require cold storage, you are correct, but Pfizers vaccine, in particular, requires minus 70 degrees Celsius storage and so they have to come up with a way to basically store the vaccine and distribute the vaccine with that cold storage in mind. Modernas has less, their requirements are less strict, their vaccine can actually be stored in a standard freezer; it can actually be refrigerated for up to 30 days, said Morici.
With 37%, the top reason some said 'no' in the Gallup poll was the fear that development of the vaccine was rushed.
NEW ORLEANS A third drug company has reached a milestone in its work to develop a COVID-19 vaccine.
Astra-Zeneca has cleared the first two phases and is now requesting emergency use of its vaccine, which it claims is up to 90-percent effective.
The company claims its vaccine is cheaper and easier to distribute than the ones developed by Pfizer and Moderna.
Now all of those companies are waiting on a panel of experts to finish reviewing the trials. That panel will weigh the benefits and risks of each vaccine and then present those findings to the Food and Drug Administration.
The public is also weighing the benefits and risks and an October poll from Gallup shows 58% of Americans are willing to get vaccinated as soon as they can.
"I will be first in line," said Beth Lasky when asked while walking in New Orleans City Park.
That leaves 42% surveyed who claim they wont.
"No ma'am," said Anthony Anthony Johnson, who was also asked in City Park. "I wasn't able to see personally what the vaccine will do or what was put in the vaccine so I can't just put it in my body."
"Just too many unknown factors," said Larryelle Mitchell.
With 37%, the top reason some said 'no' in the Gallup poll was the fear that development of the vaccine was rushed.
"I think speed was warranted," said Dr. Charles Stoecker, PhD, Assistant Professor with Tulane School of Public Health.
Most vaccines can take at least five years to get to the market. Using a new technology, these COVID vaccines were developed in less than a year. Stoecker said there's a good reason.
"This is a fast technology. It's easier to develop these mRNA vaccines," he said.
26% of those who said 'no' would not get the vaccine was they want to wait to confirm it's safe.
"That's a legitimate concern and that's why we have institutions in place to address that concern," Stoecker said referring to the trials happening now.
"For you and I, we don't have to be as brave as the people who volunteered in the clinical trials," he said.
According to the FDA, these major vaccine trials involve more than 30,000 people each.
"I think we still have some time. The trials will continue to run through the authorization process, they will have more time to document whether there are any adverse events of these vaccines," Stoecker said.
Of those who said 'no,' 12% said they don't trust vaccines in general.
"That's a problematic group," Stoecker said.
He believes the key is for enough people to get vaccinated to achieve herd immunity.
"We know from modelers that the number of people that need to be immune may be around 70 percent," Stoecker said.
One of his concerns is mistrust within the black community. That's a shadow of the horrific Tuskegee experiment. Presidents of Dillard and Xavier announced they participated in a clinical trial for a COVID vaccine. Stoecker thinks moves like that will increase willingness to get vaccinated.
"If Barack Obama gets it, I'll get it," Johnson said.
The first doses could be available this year, but time may be the biggest key to calm some of these fears.
Addressing another concern, the CDC said none of the vaccines in development use the live virus that causes COVID-19 so there is no chance you could become infected from the shots.
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Pfizer Inc. and partner BioNTech SE said they would ask the U.S. Food and Drug Administration on Friday to clear the companies Covid-19 vaccine. If the agency gives a thumbs-up, the shot would be the first to go into use in the U.S. Heres what we know and dont know.
Unclear, though the agency is expected to move quickly given the urgent need for a vaccine. It could take two or three weeks. The FDA must review data from the 44,000-subject trial on the vaccines safety and effectiveness....
The safety of the COVID vaccine is on a lot of peoples minds these days. As multiple pharmaceutical companies release promising reports about the effectiveness of their COVID vaccines, it feels like a cure for this pandemic may be in sight. But for many people injecting a brand-new scientific discovery into their body doesnt sit well. So, how can we be sure that the cure wont be worse than the disease? How do regulators decide what an acceptable side effect is? And what would happen if someone did have a serious reaction to the COVID vaccine after it was released? This weeks episode of PODCAST-19 is devoted to answering those questions.
Dont want to miss an episode of PODCAST-19, FiveThirtyEights weekly look at what we know and what we know we dont know about COVID-19? Subscribe on your favorite podcasting app. For example, heres where to do it on Apple Podcasts and Spotify.
[Related: What To Make Of Pfizers Big Vaccine Announcement]
"Healthy, normal people don't die from the flu, but with this bugger, [COVID-19], it gets everywhere, including the sensory areas," said Dr. Sandra Gibney. "So, the lungs, the brain, the small intestine, blood vessels, and neurons."
Gibney, a board-certified internist and emergency room doctor, said novel coronavirus COVID-19 is so scary because of how pervasive it is but, luckily, a vaccination is close to being available for distribution.
She knows there are some concerned citizens wondering how effective the vaccine will be, how safe it is to take, or wanting to know more about ho its made, and she joined WDEL's Rick Jensen Show Monday to try and quell some of those worries.
It didn't really matter to Gibney how effective a vaccination might be--though the ones closest to being ready for distribution have shown in the 90 to 95% range--any increase in protection was worth it.
"If you told me I had a one-in-two chance of not getting the flu, I'd still take the vaccine trying not to get the flu," she said. "And if you told me I was going to die [from COVID-19] potentially, I'd certainly would think about it."
The current leading vaccinations use a messenger RNA approach, which deliver instructions to your body's immune system to explain to your body how to combat the COVID-19 virus if it ever shows up. She liked it to a chef and a kitchen assistant using a cookbook. It doesn't change what is in your body, rewrite genetic code, or anything like that. It's only providing an ingredient.
"DNA is our cookbook, that's where the recipe is stored, in that cookbook in the library," she said. "Basically, the chef's assistant is the RNA--what we're talking about this vaccine being, that's the chef's assistant. Once that RNA, or the chef's assistant, brings the recipe, then that's injected in the body, and encodes to make a protein. So, let's say, if you will, we're making a cake. We have used a recipe to make that cake. Now the RNA is like an ingredient of the recipe. However, it doesn't change the cookbook recipe that's there."
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The temporary introduction of this code provides the body with a game plan for how to defend against it should the virus show up again at a later time. However, the construction of the vaccine is a bit unique. Messenger RNA as a delivery for the vaccine, in particular makes it more unstable than some other available medicines, and introduces the need for cold storage to maintain its stability.
"That is unique to some of the vaccines. Not all of the vaccines use messenger RNA. Moderna and Pfizer both use messenger RNA-type," Gibney said. "It is so unstable it has to be frozen and that's why delivery for those two is going to be a little bit of an issue because they have to be frozen or that very unstable messenger RNA will break down."
The delivery itself is actually a novel approach to combating a virus.
"I'm not going to say that RNA vaccines have even been FDA-approved; they haven't," Gibney said. "This is a new and novel technique, but it's probably going to be the most effective and easiest to make a lot of vaccines very quickly."
The messenger RNA model also allows medical professionals to adjust their recipes on the fly, adding or deleting ingredients as necessary depending on how the COVID-19 virus mutates or evolves on its own.
"This is why the messenger RNA will be very valuable," she said.
The Associated Press checked out false and misleading claims and videos circulating after the presidential election and news about COVID-19 vaccines. This one is bogus, even though it was shared widely on social media.
CLAIM: Researchers used lung tissue from an aborted male fetus in the creation of COVID-19 AstraZeneca vaccine.
THE FACTS: As news continues to break around the results of new COVID-19 vaccines, a widely shared video made false claims about the vaccine developed through a partnership between the British pharmaceutical company AstraZeneca and Oxford University.
The video, which had more than 160,000 views, falsely claimed: CONFIRMED- aborted Male fetus in Covid 19 vaccine.
In the video, an unidentified woman shows the packaging from a box of AstraZeneca and Oxfords COVID-19 vaccine, and urges people to share the video with anybody else that doesnt want aborted fetal tissue fragments put into them. She then shows a preprint of a University of Bristol study that tested the vaccine on MRC-5 cell lines. She explains that the cell line was originally developed from an aborted male fetus.
Is everybody OK with having that injected into themselves or their children? the woman asks.
A spokesperson for AstraZeneca confirmed to the AP that the company does not use MRC-5 cells in the development of its vaccine.
Researchers at the University of Bristol, who were independent from the vaccines development, injected the COVID-19 vaccine into MRC-5 cell lines as part of their own study. MRC-5 cells are what is known as an immortalized cell line, which can reproduce indefinitely.
Such cell lines are used in vaccine production to grow viruses in order to keep them from replicating. The AstraZeneca and Oxford vaccine relies on a harmless chimpanzee cold virus to carry the coronavirus spike protein into the body in order to create an immune response.
AstraZeneca did not use MRC-5 cells, but it did use a different producer cell line to develop it: Human Embryonic Kidney 293 TREX cells.
According to the University of Oxford development team, the original Human Embryonic Kidney 293 cells were taken from the kidney of an aborted fetus in 1973, but the cells used now are clones of the original cells. Dr. Deepak Srivastava, president of Gladstone Institutes and former president of the International Society for Stem Cell Research, said fetal cell lines were critical in developing hepatitis, measles and chickenpox vaccines.
Whats important for the public to know even if they are opposed to the use of fetal cells for therapies, these medicines that are being made and vaccines do not contain any aspect of the cells in them, Srivastava said. The cells are used as factories for production.
Misinformation around COVID-19 vaccines have public health experts concerned about the implications it could have on the adoption of the vaccine in the United States.
ByStephanie Desmon
The legal precedent for mandatory vaccinations dates back to a 1905 Supreme Court case after a smallpox outbreak in Massachusetts. But as the U.S. reaches important clinical milestones in its vaccine development efforts, questions arise relating to distribution, and who becomes vaccinated and when.
Legal and public health expert Joanne Rosen, a senior lecturer in Health Policy and Management and the Center for Law and the Public's Health, spoke with Public Health On Call podcast host Stephanie Desmon for a recent episode about the precedent of vaccine mandates. She also discusses the history of vaccine exemptions and strategies states could consider to achieve widespread vaccination for COVID-19.
The short answer is yes. States have the legal and constitutional authority to require that the people who live in that state be vaccinated, or to introduce a vaccine mandate.
The authority for the state being able to compel vaccinationthe affirmation of that authoritygoes all the way back to a U.S. Supreme Court case in 1905 called Jacobson v. Massachusetts. That case arose in the midst of an outbreak of smallpox in Cambridge, Massachusetts, in 1902. Cambridge introduced an ordinance requiring all adults be vaccinated or revaccinated against smallpox. If they didn't [get vaccinated], they would have to pay a fine of $5.
Jacobson was a resident of Cambridge who, for a number of reasons, objected to the vaccination mandate and brought a lawsuit against Massachusetts for the mandate. He raised a number of arguments, including one that his constitutionally protected liberty interests were being infringed by this mandate.
In that case, the Supreme Court said that states have under their police powers, which is under the Constitution, the authority to enact reasonable regulations as necessary to protect public health, public safety, and the common good. Vaccination mandates constitute exactly that kind of permissible state action to protect the public's health. Even though it's 115 years old, this continues to be the benchmark case on the state's power to mandate vaccination.
Coverage of how the COVID-19 pandemic is affecting operations at JHU and how Hopkins experts and scientists are responding to the outbreak
In response to the argument about this individual liberty interest, the court said that sometimes individual interests might have to yield to state laws that endeavor to protect the health of everybodythe "common good." The court said: "The rights of the individual may at times, under the pressure of great dangers, be subjected to such restraint to be enforced by reasonable regulations as the safety of the general public may demand."
So, yes: Once COVID vaccines are available, states could elect to require that people who live within that state be vaccinated.
By and large, our immunization schedule begins as children, and we have to show proof of vaccination to go to school. It is a more complicated administrative manner to have a vaccine mandate that applies to adults because there isn't a point of common intersection with the state or with some agency of the state the way we have with children. I don't have a clear idea of this, but that would be something that states would have to work into a mandate. A requirement that people be vaccinated is only as effective as the way of ensuring that they are.
That also raises issues that the vaccine has to be made available without charge or in a way that allows people to get coverage for it if it's not covered by their insurance. Againhow are we able to keep track?
The other advantage that school-based proof of vaccination offers is for people who have some medical reason to not be vaccinated. All vaccine mandates include a medical exemption for people whose health would be imperiled because of an allergy to something in the vaccine or because they are immunocompromised or any other reason. When you go to school and show your proof-of-vaccination certificate or show that you've been exempted and you're not vaccinated, it means that public health offices have a record of who is and who isn't vaccinated. In the event of an outbreak of one of these vaccine-preventable diseases, we can identify and isolate the people who haven't been vaccinated and who are obviously at higher risk for being infected.
Yes, absolutely. The measles outbreak in New York was about a year or two ago and, in California, it was traced to Disney World in 2014 or 2015.
The reasons for these outbreaks were religious exemptions in New York and personal belief exemptions in California. The legislators of California and New York revoked nonmedical exemptions as a result so that they could ensure higher rates of people immunized against measles. And, guess what? The rate of measles immunizations did go up when those exemptions were removed.
One of the reasons that nonmedical exemptions were introduced in the first place was to try to respond to and prevent vaccine-related backlash. There's a very strong culture in this country and others of personal autonomy and not wanting the government to force you to do something or tell you what to do. People wanted to be able to make their own decisions about the risks they're willing to take. The introduction of these exemptions, in part, was kind of like a safety valve to let some of the pressure out of the system so that people could feel that they had some choice.
Although it seems counterintuitive, providing some opt-out mechanism in fact can protect the overall integrity and legitimacy of the vaccine regime and public health. Yes, the goal of public health is to ensure that as many people as possible are vaccinated to prevent further transmission of disease. This leaves the question of "How best do we achieve that goal?" A vaccine mandate looks like it's the most straightforward way to do it. But, if we have a lot of backlash and resistance to it, how do we then bring those folks onside?
One approach might be to start with a strong recommendation and education campaign. Physicians and health care providers can be part of this effort to educate people about the safety of vaccines. A particular issue that we may face with a COVID-19 vaccine that does arise with other vaccines, but not to the same degree, are questions about [safety] because it's brand new. Measles, mumps, rubella, polio, and smallpox vaccines have been around for decades, if not even longer. They are regarded as safe and we have decades of data. But COVID-19 vaccines are brand new, so there will probably be more concernseven among people who are fully vaccinated against other diseases and who have vaccinated their children.
One approach, perhaps, to start is strong recommendation, and being transparentas drug companies are doing their best to doabout what they know about safety. Then, once the vaccines are available, states can make it as easy as possible to get vaccinated. Even in the absence of a mandate, when you are vaccinated, there are public records kept and they can see what percentage of residents have voluntarily been vaccinated. If the percentage is high enough to ensure that the whole community is protected, there wouldn't be a need for a mandate.
They can and they have. It's very common in particular sectors. An employer has to have a "reasonable basis." If you worked in retail, I'm not sure a corporate entity could require that. They may want you to and recommend it, but it wouldn't be reasonably related to the requirements of their job.
But in sectors in which the employees are themselves at greater risk of contracting vaccine-preventable illnesses or who work with populations that are especially vulnerable if they do get sick, like hospital workers, health care workers, and people who work in [long-term care] facilities, employers have required that their staff be vaccinated against the flu each year.
Another thing that states could do, short of a requirement across the board that everybody be vaccinated, is they could begin with a mandate that focuses on those sectorspeople who are themselves at greater risk or who work in proximity with vulnerable populations. We don't want the employees themselves getting sick and being a bridge, or "vector," to infecting others who are vulnerable. People may object, but some more targeted form of vaccine mandate may make sense and also be possible.
This article originally appeared online as part of the Bloomberg School of Public Health's COVID-19 Expert Insights webpage.
