Vaccine advisers to the U.S. Centers for Disease Control and Prevention voted 15-0 Thursday to change recommendations for COVID-19 vaccines to make clear that shots made by Moderna and Pfizer/BioNTech are preferred over Johnson & Johnson's vaccine.

The new recommendation: "mRNA vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of Covid-19 for those 18 years of age and over."

Related video above: Omicron spreads 70 times faster than delta in certain respiratory tissue, researchers say

The CDC's Advisory Committee on Immunization Practices endorsed the updated recommendation after hearing new data indicating that a rare blood clotting syndrome is more common among people who recently got a J&J vaccine than previously believed. The CDC has logged 54 cases in the U.S. of thrombosis with thrombocytopenia syndrome or TTS in the U.S. since the vaccine became available. Nine people have died -- seven women and two men.

ACIP members considered the new data and weighed it against numerous studies showing J&J's vaccine is less effective than the Moderna and Pfizer/BioNTech vaccines in preventing infection. They also discussed the risks of completely removing J&J's vaccine as an option, as well as the potential confusion and mistrust that might be caused by changing recommendations about the vaccine.

"We will absolutely emphasize how important education around the risk of these events is," the CDC's Dr. Sara Oliver told the meeting.

Earlier this week, the U.S. Food and Drug Administration strengthened language in the fact sheet that goes along with the Janssen vaccine, saying it should not be given to anyone with a history of TTS.

Vaccine advisers to the Food and Drug Administration are meeting Thursday morning to discuss whether to authorize boosters of Moderna's coronavirus vaccine for some adults.

It's the first portion of a two-day Vaccines and Related Biological Products Advisory Committee meeting that will also include a vote on boosters for the Johnson & Johnson vaccine and a presentation on mix-and-match vaccines. Thursday's agenda focuses on Moderna boosters, and includes a presentation by Moderna, and another by the FDA, which will provide its assessment of Moderna's booster data.

Moderna is requesting authorization for a 50-microgram booster dose — half the size of the 100-microgram doses used in the primary series of the two-dose vaccine — at least six months after the second dose, and only for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe COVID-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for COVID-19 complications or severe illness.

Moderna's request mirrors the groups authorized to receive a booster dose of Pfizer's mRNA vaccine. Third doses of the Moderna and Pfizer COVID-19 vaccines are already authorized for some immunocompromised people.

On Thursday, the committee will hear from Dr. Peter Marks, the director of FDA's Center for Biologics Evaluation and Research who recently took over as acting director of the agency's Office of Vaccines Research and Review as two of its senior leaders prepared to depart the agency.

Israeli researchers will also brief VRBPAC on booster data from there; most people in Israel received the Pfizer COVID-19, and boosters for vaccinated people began weeks before the United States authorized Pfizer boosters. The presenters, Dr. Sharon Alroy-Preiss, director of public health services at Israel's Ministry of Health and Ron Milo, a professor at Israel's Weizmann Institute, spoke in support of Pfizer's booster application last month.

The meeting, which will be streamed online, is scheduled to last until 4:45 p.m. ET. A two-hour period for discussion and voting is scheduled to begin at 2:45 p.m. ET.

The FDA's committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine. If the FDA gives emergency use authorization to Moderna boosters, vaccine advisers to the U.S. Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation.

CDC's Advisory Committee on Immunization Practices is already scheduled to meet to discuss boosters from 10 a.m. to 5 p.m. ET Oct. 20-21.

BIDDEFORD, Maine — Students are returning to campuses as colleges reopen their doors. About one in four U.S. schools require those students to get vaccinated for COVID-19, following guidelines from the American College Health Association.

"American College Health Association believes that the best protection, the best way to bring our faculty, staff and students back safely, is to have a fully vaccinated campus," said Dr. Sarah Van Orman.

She helped create the COVID-19 protocols in use around the country.

"I think for most of us, it's about balancing a return to normal, and how do we do those safely? What mitigation systems do we need to have in place?" said Van Orman.

Vaccine mandates are working at the University of New England (UNE). The picturesque campus is home to nearly 4,000 students and 1,100 staff members.

For the university's president, James Herbert, it’s several thousand people he’s responsible for keeping safe from COVID-19.

“It’s been quite the roller coaster the past 18 months, a lot of ups and downs. But we’ve actually weathered the pandemic quite well overall,” said Herbert

He’s hoping the roller coaster ride, at least on campus, may be slowing down.

“Now, we’ve gotten to the point where we’re over 98% of our community is vaccinated and with just a handful of exemptions,” said Herbert.

It’s not just UNE. About 94% of students living on campus in the University of Maine system are vaccinated. Multiple other colleges in Maine are reporting near 100% vaccination rates as well.

The number is substantially higher than the overall rate for 18 to 24-year-olds in the U.S. Only 43.5% have received the vaccine.

Herbert says vaccine requirements are a driving force. A total of 34 of Maine’s 37 universities require students to get the shot.

“The majority of the students responded very well. They understood why we needed to have the vaccine,” said Herbert.

For medical school students Julia Marcus and Molly Cherny, it made the decision to come to school that much easier.

“I thought it was awesome that UNECOM or UNE, in general, was mandating vaccines just for the safety of all the students and all the faculty,” said Marcus

“I’m sure there was an exemption or two but for the most part, we never even questioned it in the past to have a hepatitis or a menegitis or measles, mumps and rubella vaccine, so it kind of was like I said, just another box for me to check off,” said Cherney.

But while schools with mandates have generally reported high vaccination rates, it's a mixed bag for the 3,000-plus schools that do not have a mandate in place. Many do not publicly report their vaccination rates.

"When we think about the vaccine rates at an institution, we have to understand where does that institution sit. What are the overall vaccine rates in the community," said Van Orman.

The University of Alabama system, with no vaccine requirement, is reporting a vaccination rate of around 58%.

But the University of Wisconsin, which also decided against a mandate, has vaccinated more than 90% of students.

"I think it's a good example of what you see when you have that strong vaccine infrastructure, and a community acceptance and awareness of the vaccine, versus a state where we have a longer way to go," said Van Orman.

Herbert has faced doubters on his campus. He says his team has responded with compassion.

“What we tried to do is meet people where they were at rather than hit them over the head with a bunch of facts and figures to listen to what their concerns were and to try and meet them where they were at,” said Herbert. “This is, right now, one of the safest places on planet earth that you could be in is our campus when we have almost 99% of the community vaccinated.”

Seven-year-old Clark McGinnity and his nine-year-old brother Henry are both participating in the Moderna COVID-19 vaccine trial.  

Right now, a child under 12 can't get a COVID vaccine unless they're part of a clinical trial. It comes down to dosing-balancing a shot's protection without causing severe side effects. 

"I don't think it's taking longer than it did on the adults," pediatric infectious disease specialist Mike Smith said. "But people need to understand that it's a whole separate set of studies because the dose is different."

We spoke with Dr. Michael smith. He's involved in the pediatric trials of Pfizer's COVID-19 vaccine.

Pfizer, Moderna, and Johnson and Johnson researchers are still gathering data.  

Because children's immune systems are still growing, researchers study by age groups of five-to-12 years old, two-to-five years old, and two-to-six months old. 

Just like the adult COVID trials in previous months, they start with smaller phase one clinical trial groups to get the dosing right.  

"I'm a parent of two children who are both under 12, so I share this concern," Smith said. "I really wish my kids were vaccinated. However, I also want to make sure they have the right dose." 

Smith says the Pfizer dose for kids under 12 is about a third of the dose for everyone else. For Moderna, it's about a half of the full adult dose. 

Those phase one dosing trials are still monitoring longer-term safety data right now, as the phase two and three are underway, too.  

With those, half get a saline shot and the other half get the real thing. The double-blind studies are the credible gold standard. 

Charles Mugera's eight-year-old son, Christian is participating in the Moderna trial in Baltimore.  

"I think for the children, ultimately, what was the most appealing to them was the fact that they got their life back," he said.

Mugera – a doctor – gets the risks and the continued monitoring-a crucial piece of the vaccine timeline puzzle.  

In these trials, parents will follow up for months after their child's second vaccine, checking in daily to record any side effects like fever or soreness.   

Each of those check-ins means multiple data points. On top of blood draws and antibody numbers – all pieces the researchers, then drugmakers, then FDA will go through.

To request emergency authorization for kids under age 12, companies need to turn in four-to-six months of safety results. For the adults, only two months were needed. 

"I think the FDA is doing their job here," Smith said. "It's just that they're kind of stuck in a hard place because you're in the middle of a public health crisis."

One thing we haven't heard much about, when would something like nasal mists for kids – like we see for flu season, for example – be a possibility. 

Scientists say that would take much longer – a couple of years.  

This story was first reported by Lindsey Theis on Newsy.com.

Johnson & Johnson’s long-awaited vaccine appears to protect against COVID-19 with just one shot – not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses.

J&J said Friday that in the U.S. and seven other countries, the single-shot vaccine was 66% effective overall at preventing moderate to severe illness, and much more protective — 85% — against the most serious symptoms.

There was some geographic variation. The vaccine worked better in the U.S. — 72% effective against moderate to severe COVID-19 – compared to 57% in South Africa, where it was up against an easier-to-spread mutated virus.

“Gambling on one dose was certainly worthwhile,” Dr. Mathai Mammen, global research chief for J&J’s Janssen Pharmaceutical unit, told The Associated Press.

With vaccinations off to a rocky start globally, experts had been counting on a one-dose vaccine that would stretch scarce supplies and avoid the logistics nightmare of getting people to return for boosters.

But with some other competing vaccines shown to be 95% effective after two doses, at question is whether somewhat less protection is an acceptable tradeoff to get more shots in arms quickly.

The company said within a week, it will file an application for emergency use in the U.S., and then abroad. It expects to supply 100 million doses to the U.S. by June, and expects to have some ready to ship as soon as authorities give the green light.

These are preliminary findings from a study of 44,000 volunteers that isn’t completed yet. Researchers tracked illnesses starting 28 days after vaccination – about the time when, if participants were getting a two-dose variety instead, they would have needed another shot.

After day 28, no one who got vaccinated needed hospitalization or died regardless of whether they were exposed to “regular COVID or these particularly nasty variants,” Mammen said. When the vaccinated did become infected, they had a milder illness.

Defeating the scourge that has killed more than 2 million people worldwide will require vaccinating billions, and the shots being rolled out in different countries so far all require two doses a few weeks apart for full protection. Early data is mixed on exactly how well all the different kinds work, but shots made by Pfizer and Moderna appear to be about 95% protective after the second dose.

But amid shortages, some countries have advised delaying the second dose of certain vaccines with little data on how that would affect protection.

All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that coats it. But they’re made in very different ways.

J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along.

Rival AstraZeneca makes a similar cold virus vaccine that requires two doses. Both the AstraZeneca and J&J vaccines can be stored in a refrigerator, making them easier to ship and to use in developing countries than the frozen kind made by Pfizer and Moderna.

It’s not clear exactly how well the AstraZeneca version, being used in Britain and several other countries, works. Tests in Britain, South Africa and Brazil suggested two doses are about 70% effective although there are questions about how much protection older adults get. An ongoing U.S. study may provide more information.

J&J said its vaccine works consistently in a broad range of people: A third of participants were over age 60, and more than 40% had other illnesses putting them at risk of severe COVID-19, including obesity, diabetes and HIV.

J&J said the vaccine is safe, with reactions similar to other COVID-19 shots such as fever that occur when the immune system is revved up.

While it released few details, the company said there were no serious allergic reactions. But occasionally other COVID-19 vaccines trigger such reactions, which can be reversed if promptly treated – and authorities have warned people to be on the lookout regardless of which type of vaccine is used.

J&J had hedged its bets with a study of a two-dose version of its vaccine, which is still underway.

Friday's interim results come on the heels of another vaccine in final testing. Novavax reported this week that its vaccine appears 89% effective in a U.K. study and that it also seems to work — though not as well — against new mutated versions of the virus circulating in Britain and South Africa. A larger study in the U.S. and Mexico is still enrolling volunteers.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Members of the White House COVID response team say vaccinations are ramping up with six million people getting a shot in the past seven days. 

But while vaccinations are up, so are COVID case numbers and hospitalizations 

Officials are urging local leaders and private companies to enact more vaccine mandates now that the Pfizer vaccine has received full FDA approval.

Dr. Anthony Fauci has said we could see the beginning of the end of the pandemic next spring – but added vaccines are the best way to get there.

"Rather than focus on the situation of getting a specific timeline, I would like to appeal to this country – to the people in the country who are not vaccinated – to realize that we have the capability among ourselves to essentially cut down the time frame to getting the end of this pandemic very, very clearly by just listening to everything you have heard on this press conference," he said. "Get vaccinated and the time frame will be truncated dramatically."

This story was originally reported on Newsy.com.

CINCINNATI — The Vaccine Research Center at Cincinnati Children’s Hospital Medical Center is one of five clinics looking to find out.

This “mix-and-match” trial, funded through the National Institutes of Health, is looking into the safety and effectiveness of getting one manufacturer's COVID-19 vaccine for the first round and then getting another manufacturer's vaccine for a second shot or possible booster.

"We're mixing things up, we're matching things and allowing us to be able to see, 'Does that change our immune response? Does it change our safety profile?' So we have the information,” said Vaccine Research Center director Robert Frenck.

The trial will look at various combinations, like two doses of Moderna and then a third dose of Pfizer, or a dose of Johnson & Johnson followed by a dose of Pfizer.

Frenck said he’s hopeful that mixing manufacturers will pan out, but he's waiting for the science to back up his hypothesis.

"As doctors, we think that's going to be OK, but as scientists we want to know that that's OK,” he said. "In a real-world setting, if you go into Kroger today and you got a Moderna vaccine, and you go to Walgreens and you got Pfizer, and some other pharmacy says, 'What did you get last time?' And you said, 'I don't know. I just got a vaccine.'"

More importantly than planning for future boosters, he said the main focus right now should be on people getting their initial vaccines.

"The far more important thing is to get the other 50 to 60% of the people who haven't had their primary series," he said, referring to the regimen of two shots necessary for the recipient to achieve the highest level of immunity.

At Mullaney’s Pharmacy in Pleasant Ridge, director of operations Troy Stinson is seeing an uptick in appointments.

"The last week or two, we're really having a lot of calls for it, people wanting to schedule appointments again,” Stinson said. "A lot of people recently have been getting the J&J because it's the one-time."

So far he hasn’t come across any questions or confusion about mixing the vaccines, but he does have advice for what to do when the time for boosters or a second shot comes up.

"Hold on to the card, bring it back in,” Stinson said. “And if you got the first one with us, it's in the system. And, honestly, we can search if you got it anywhere."

Right now the “mix-and-match” research is still in the clinical trial phase. The World Health Organization is advising people to stick to one manufacturer until more information is available.

The U.S. Food and Drug Administration has authorized the use of the Johnson & Johnson coronavirus vaccine in adults.

Maureen Ferran, a virologist at the Rochester Institute of Technology, explains how this third authorized vaccine works and explores the differences between it and the Moderna and Pfizer–BioNTech vaccines that are already in use.

1. How does the Johnson & Johnson vaccine work?

The Johnson & Johnson vaccine is what's called a viral vector vaccine.

To create this vaccine, the Johnson & Johnson team took a harmless adenovirus – the viral vector – and replaced a small piece of its genetic instructions with coronavirus genes for the SARS-CoV-2 spike protein.

After this modified adenovirus is injected into someone's arm, it enters the person's cells. The cells then read the genetic instructions needed to make the spike protein and the vaccinated cells make and present the spike protein on their own surface. The person's immune system then notices these foreign proteins and makes antibodies against them that will protect the person if they are ever exposed to SARS-CoV-2 in the future.

The adenovirus vector vaccine is safe because the adenovirus can't replicate in human cells or cause disease, and the SARS-CoV-2 spike protein can't cause COVID–19 without the rest of the coronavirus.

This approach is not new. Johnson & Johnson used a similar method to make its Ebola vaccine, and the AstraZeneca-Oxford COVID-19 vaccine is also an adenovirus viral vector vaccine.

2. How effective is it?

The FDA's analysis found that, in the U.S., the Johnson & Johnson COVID-19 vaccine was 72% effective at preventing all COVID-19 and 86% effective at preventing severe cases of the disease. While there is still a chance a vaccinated person could get sick, this suggests they would be much less likely to need hospitalization or to die from COVID-19.

A similar trial in South Africa, where a new, more contagious variant is dominant, produced similar results. Researchers found the Johnson & Johnson vaccine to be slightly less effective at preventing all illness there – 64% overall – but was still 82% effective at preventing severe disease. The FDA report also indicates that the vaccine protects against other variants from Britain and Brazil too.

3. How is it different from other vaccines?

The most basic difference is that the Johnson & Johnson vaccine is an adenovirus vector vaccine, while the Moderna and Pfizer vaccines are both mRNA vaccines. Messenger RNA vaccines use genetic instructions from the coronavirus to tell a person's cells to make the spike protein, but these don't use another virus as a vector. There are many practical differences, too.

Both of the mRNA-based vaccines require two shots. The Johnson & Johnson vaccine requires only a single dose. This is key when vaccines are in short supply.

The Johnson & Johnson vaccine can also be stored at much warmer temperatures than the mRNA vaccines. The mRNA vaccines must be shipped and stored at below–freezing or subzero temperatures and require a complicated cold chain to safely distribute them. The Johnson & Johnson vaccine can be stored for at least three months in a regular refrigerator, making it much easier to use and distribute.

As for efficacy, it is difficult to directly compare the Johnson & Johnson vaccine with the mRNA vaccines due to differences in how the clinical trials were designed. While the Moderna and Pfizer vaccines are reported to be approximately 95% effective at preventing illness from COVID–19, the trials were done over the summer and fall of 2020, before newer more contagious variants were circulating widely. The Moderna and Pfizer vaccines might not be as effective against the new variants, and Johnson & Johnson trials were done more recently and take into account the vaccine's efficacy against these new variants.

4. Should I choose one vaccine over another?

Although the overall efficacy of the Moderna and Pfizer vaccines is higher than the Johnson & Johnson vaccine, you should not wait until you have your choice of vaccine – which is likely a long way off anyway. The Johnson & Johnson vaccine is nearly as good as the mRNA-based vaccines at preventing serious disease, and that's what really matters.

The Johnson & Johnson vaccine and other viral-vector vaccines like the one from AstraZeneca are particularly important for the global vaccination effort. From a public health perspective, it's important to have multiple COVID-19 vaccines, and the Johnson & Johnson vaccine is a very welcome addition to the vaccine arsenal. It doesn't require a freezer, making it much easier to ship and store. It's a one-shot vaccine, making logistics much easier compared with organizing two doses per person.

As many people as possible need to be vaccinated as quickly as possible to limit the development of new coronavirus variants. Johnson & Johnson is expected to ship out nearly four million doses as soon as the FDA grants emergency use authorization. Having a third authorized vaccine in the U.S. will be a big step towards meeting vaccination demand and stopping this pandemic.

This article is republished from The Conversation under a Creative Commons license. Read the original article here.

SAN DIEGO — A new study released Tuesday suggests the COVID-19 vaccine made by Johnson & Johnson produces significantly weaker antibody defenses to the delta variant than the original strain.

However, medical experts say the results are far from proof that the one-dose vaccine is ineffective against the variant in the real world.

The study by a team at New York University prompted a flurry of concerned headlines Tuesday. The New York Times initially published a report titled, "One Dose of J.&J. Vaccine Is Ineffective Against Delta, Study Suggests."

The paper later changed the title to "J.&J. Vaccine May Be Less Effective Against Delta, Study Suggests."

The NYU scientists drew blood from 10 people who got the J&J vaccine and put their protective antibodies in a dish. Then, they introduced different COVID-19 variants to see how well the antibodies stopped them.

On average, the team found the Johnson & Johnson vaccine was about seven times weaker against the delta variant than the original strain of COVID-19. Those results were a more significant drop-off than those seen in people who received the Pfizer or Moderna vaccine.

The NYU study has not yet undergone peer review.

J&J is the only one-dose COVID-19 vaccine approved for emergency use in the U.S. The authors of the paper suggested that people who got the shot may benefit from a second dose.

However, outside experts like UC San Francisco's Dr. Peter Chin-Hong said it's too soon to make that assumption.

"You can't necessarily extrapolate laboratory-based studies to what happens in real life," he said.

That's because vaccines create more defenses than just antibodies. They also train living cells called "Killer T cells" and "Helper T cells." The three branches work together like branches of the military — the army, the navy and the air force.

"What we've known about J&J for a while is that the protection doesn't directly track with those antibody numbers," said Dr. Shane Crotty, a professor at the La Jolla Institute of Immunology.

During the company's clinical trials in South Africa, the Johnson & Johnson vaccine was 64% effective against the elusive variant there, now called the beta variant.

While the new NYU study did not measure T cell responses, it found the J&J antibodies perform about the same against delta as they do against beta — an encouraging clue, Crotty said.

The Johnson & Johnson vaccine "may lose a little more of its protection against just cases per se, but it'll still stay really highly protective against bad COVID, hospitalization level COVID," he said.

The one-dose J&J vaccine was authorized later than Pfizer's and Moderna's vaccines, so there have been fewer studies on it.

The NYU study conflicts with some of the earlier data. Experts say that could be because the team ran tests less than three months after the shot, on average.

Johnson & Johnson released research this month that found antibody levels grew in strength over eight months.

"Just like wine, it may get better with age," Chin-Hong said.

For now, experts say the bigger worry is about those who are still unvaccinated — people who have not gotten the shot account for 99% of the hospitalizations and deaths from the delta variant.

This story was originally published by Derek Staahl on Scripps station KGTV in San Diego.

CINCINNATI —

New research by scientists in Cincinnati is looking at whether different Food and Drug Administration emergency-approved COVID-19 vaccines can be mixed if there’s a need for boosters.

Cincinnati Children’s Hospital is researching the possibility of using the mRNA Moderna vaccine as a booster for the one-shot DNA Johnson & Johnson vaccine.

Children’s Hospital will soon be looking at other combinations of approved vaccines too.

“We know people are going to go do this, so we want to have data to inform the community. It may not be the greatest idea, or maybe it looks fine, it doesn’t cause any problems,” said Dr. Robert Frenck of Children’s Hospital.

Frenck led the Pfizer vaccine research at Children’s and is now leading the research on COVID-19 vaccines for children. He’s also part of the new research into boosters and combining vaccine platforms.

Frenck said there are lots of unknowns about mixing vaccines for boosters right now.

“Does that make any difference in the side effects? Does it have any effect in their immune response? Does it go up compared with people who stayed with the same vaccine?” Frenck said.

Another series of studies are being done by the global company CTI, headquartered in Cincinnati and Northern Kentucky.

CTI is studying a Johnson & Johnson vaccine with a Johnson & Johnson booster.

Another important question is if boosters will be needed at all.

Frenck said the most current data shows the vaccines are as effective at six months as they were at two months.

“We were concerned that the vaccine would only last a few months and we would need a booster. Right now, if things stay the way they are, we may not need one,” Frenck said.

Doctors are stressing the chance of getting blood clots from the Johnson & Johnson vaccine appears to be very rare.

The U.S. on Tuesday recommended a "pause" in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of rare but potentially dangerous blood clots, a development that could jeopardize the rollout of vaccines around the world.

"Right now, these adverse events appear to be extremely rare," FDA and CDC doctors said in a joint statement about the pause.

The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots that occurred 6 to 13 days after vaccination. The FDA commissioner said she expected the pause to last a matter of days.

Dr. Anthony Fauci says Americans who've recently received a Johnson & Johnson COVID-19 vaccine shouldn't be anxious about the "pause."

The nation's top infectious disease expert says, "It's less than one in a million." Fauci adds people should "pay attention" to symptoms associated with the blood clots, particularly between one and three weeks after the shot.

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Mississippi Health Officer Dr. Thomas Dobbs said the condition is extremely rare and those who have already received the J&J shot should not worry.

Doctors with the federal health departments said people who have received the J&J vaccine "who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

More than 6.8 million doses of the vaccine, which is also known as the Janssen vaccine, have been administered as of Monday in the U.S., according to the CDC.

The Pfizer and Moderna vaccines are not affected. Dr. Geoffrey Barnes, cardiologist and vascular medicine specialist in Michigan, said there has not been a sign of blood clot risk with those vaccines.

"It's important to note that we do not yet know if there is a real risk of clotting associated with the J&J/Janssen vaccine," Barnes said on a University of Michigan Health System website. "So far, there are very few reported cases (six) despite millions of doses administered."

Barnes said it's wise to be putting the vaccine on pause and that the clots seem to be quite rare.

"The risk of blood clots in patients with COVID is far higher than the very small risk of a blood clot following a COVID-19 vaccine," Barnes said. "Overall, the benefits of COVID-19 vaccination greatly outweigh the very small risks."

Barnes said doctors are aware of the condition and have the tools to diagnose and treat patients if it occurs.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the pause will help give physicians insight for treating people to know if a treatment should be avoided.

The Associated Press contributed to this report.

CINCINNATI —

There is “no direct evidence” that the COVID-19 vaccine killed a 21-year-old University of Cincinnati college student, Hamilton County Coroner Lakshmi Sammarco said.

Speaking to media Friday afternoon, Sammarco said John Francis Foley, 21, died Sunday, one day after being administered the Johnson & Johnson vaccine.

Cincinnati police responded to the Columbus native's off-campus housing after 9 p.m. Sunday, but it is not clear if he died at home or at the hospital.

His cause of death has not been determined; however, a preliminary autopsy report filed with the Hamilton County Coroner's Office appears to be leaning toward a heart or breathing issue.

His death came into question due to the close proximity to Foley being administered the single-shot Johnson & Johnson vaccine. He was given the vaccine Saturday, and died the following day.

“By preliminary autopsy findings, we don’t see a direct connection between the two," Sammarco said. “There’s some misinformation about clots or pulmonary emboli, and again on autopsy, we did not find any evidence of that.”

Sammarco added that the investigation is still in the preliminary stages.

Foley is being remembered for his positive attitude and as a generous, caring and loving friend. He was studying medical sciences at the university. He had been on the dean's list every semester.

Foley's family released a statement, which reads:

“Our beloved son John Francis Foley is gone, and our family mourns the loss of this wonderful and sweet joy of our lives. While the facts remain unclear how he died, we are rejoicing in how he lived: caring for others, lit with God’s grace, and generous to all. We know the doctors involved are doing their best. We must be patient, and we ask everyone else to be patient too. John was going to be a doctor, so this is what he would want.

“we understand many want to know more about his death – we do too – but we ask people to understand that this is the time for our family to grieve in private. Thank you.”

NEWPORT, Ky. —

Al Watts was one of many to receive a COVID-19 vaccine at Newport Intermediate School.

Medical complications possibly linked to the Johnson & Johnson vaccine forced a change in administration.

“I just wanted the one-shot, so I don’t have to worry about it anymore. Now I have to take the second shot and that’s fine, I just want the shots and get it over with.” Watts said.

Linda Bates of Well Care Health Plans coordinated the clinic.

“The health department was very responsive in switching medications, so now we are scheduling the second appointment when we finish today,” Bates said.

That flexibility has in part defined the response to COVID-19.

“One of the most important things is bringing services to people where they are and serving them the best way we can in their communities and their comfort zones.” Bates said.

This vaccine clinic operated in partnership between the Northern Kentucky department of Health and the school district.

Jennifer Stewart of Newport Independent Schools said the district sees this as a move forward.

“This puts us one step closer to putting our kids back to school 5 days per week. We are looking forward to coming back in August and having a normal school year for our families.”

Getting his shot, Watts puts today’s shot in a familiar perspective.

“I’ll just be glad when things get back to normal. I’m tired of wearing the mask and want people can see my pretty smile. I’ve got a pretty smile. and you can’t see it.”

BUFFALO, N.Y. — New York Gov. Andrew Cuomo introduced a "Vax and Scratch" program Thursday that gives residents of the state a chance to win up to $5 million for getting vaccinated against COVID-19.

According to Cuomo, beginning Monday, May 24 and until Friday, May 28, if you get vaccinated at one of 10 New York state COVID-19 vaccine sites, you will receive a $5 million Mega Multiplier scratch-off lottery ticket.

The ticket normally costs $20 and you have a one in nine chance of winning something.

NYS Governor's Office

The following COVID-19 vaccination sites will offer the program:

• University at Buffalo South Campus

• Rochester Dome Arena
• State Fair Expo Center: NYS Fairgrounds
• SUNY Polytechnic Institute
• New York National Guard Armory
• Bronx - Bay Eden Senior Center
• SUNY Stony Brook
• York College - Health and Physical Education Complex - Queens
• Medgar Evers College - Brooklyn
• Javits Center

NYS Governor's Office

The governor says this is just a pilot program for next week, but state officials will see how the program goes and make a decision from there on if it will be extended.

A similar program was recently launched in Ohio and it was seen to be successful. On Tuesday, the state said thousands of vaccinated Ohioans had signed up for its lottery offering free tuition or $1 million to 10 lucky people who have gotten a shot.

This story was originally published by Anthony Reyes at WKBW.

CINCINNATI — Ohio Gov. Mike DeWine during a visit Friday to Cincinnati's West Side offered some speculation on a question many have been asking as COVID-19 vaccine supply begins to outpace demand.

Can an employer mandate their employees receive the coronavirus vaccine?

"I think you're going to see private businesses more inclined maybe to make that an order," DeWine said.

All three types of COVID-19 vaccine available in the U.S. today -- Pfizer/BioNTech, Moderna and Johnson & Johnson -- are on the market with emergency use authorization. That's just one step away from full approval from the Food and Drug Administration.

With Pfizer now poised to request full approval of its vaccine, it could open doors for employers to compel their employees to receive the vaccine in order to go back to work, DeWine said, because full FDA approval would close some liability loopholes companies currently face if they were to mandate a emergency-approved inoculation.

"I talked to somebody literally two hours ago on the phone, private business," DeWine said Friday. "I wasn't encouraging it or not, and this person said to me, 'July one. We've already told our folks everybody's got to be vaccinated.'"

But business owner Tim Meehan said a vaccine requirement makes him uneasy. He and his partner Halle visited Deerfield Cinema today, enjoying a movie now that they're fully vaccinated themselves.

"I know that's a personal choice," Tim Meehan said. "I think it's important to get the vaccine, but I don't know about forcing employees to get it."

Cincinnati Health Commissioner Melba Moore supports people getting vaccinated but is wary of mandates, too.

"I don't like the stick approach," Moore said. "Let me give you the science and the information, and let's do what we need to do to get back to what this new normal is going to be."

As part of that approach, Moore's health department will throw a block party Saturday in Hartwell at 8725 Vine Street. A vaccine clinic offering the single-dose Johnson & Johnson shot will operate from 10 a.m. to 5 p.m., with walk-up appointments available until 4 p.m. There will be food and live music.