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Physician on CDC advisory panel expects pause lifted

A member of a key CDC advisory body told CNBC Friday morning that he expects the U.S. hiatus on Johnson & Johnson’s one-off coronavirus vaccine to be lifted at some point.

“I think we are ready to use this vaccine. We had to take an important pause to review this safety information to consider the risks. But I think there is a large amount of evidence that the Benefit far outweighs this risk, “said Dr. Wilbur Chen, professor in the University of Maryland School of Medicine.

Chen spoke on the Worldwide Exchange before attending a meeting of the Agency’s Advisory Committee on Immunization Practices later on Friday to discuss the rare but serious bleeding disorder some women had after receiving the J&J shot.

In addition to the six patients who experienced rare but severe blood clotting problems after receiving the vaccine, the CDC is investigating two other possible cases: a deceased Oregon woman and a Texas woman who was hospitalized. Of the original six women, one died and one became seriously ill. Approximately 8 million J&J vaccine doses have been administered.

Concern over the problem led the Centers for Disease Control and Prevention and the FDA to temporarily stop using the J&J vaccine in the US last week. When asked by CNBC’s Brian Sullivan whether he believes Americans will get the J&J vaccine at some point, Chen said, “Yes.”

The Advisory Committee on Immunization Practices, known as ACIP, is an external panel of experts that makes recommendations to the CDC. A meeting on the J&J vaccine was called last week, but a decision was postponed until this week. Ultimately, it is up to the CDC and the Food and Drug Administration what to do next.

Chen said ACIP now has better information about the blood clotting problems on which to base its vaccination instructions. “We’ll be able to get a good sample size. It may not be perfect, but we don’t have to be perfect to have actionable information,” said Chen, adding that he expects the panel to “get a number.” working out of recommendations that I think everyone will be happy with. “

In a statement emailed to CNBC, CDC Director Dr. Rochelle Walensky, she hopes the Public Health Agency will receive a “recommendation” that considers the risk versus benefit of using the Johnson & Johnson vaccine based on the new case data and the risk-benefit ratio analysis CDC has in last week. “

“I really appreciate the complex issue before the committee and look forward to hearing from you. I also appreciate the importance of working with the FDA to act quickly as soon as we hear about ACIP,” added Walensky .

Given the urgency of the coronavirus pandemic, some people have criticized the decision to discontinue the J&J Covid vaccine – which only requires one dose for full immunity protection – while the clot investigation was in progress.

Chen disagreed.

“The risk is very, very small, but until we could fully take into account this information we haven’t been able to contextualize this for the rest of the medical community and the public too,” he said. “We only took a 10-day break. Hopefully this won’t be detrimental in the long term, but we obviously want to instill confidence in the security information collection system.”

The other two emergency-approved Covid vaccines in the US come from Pfizer and Moderna. Both require two shots.

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Nick Springer, Paralympic Gold Medalist, Dies at 35

After a three day 30 mile hike, he experienced flulike symptoms that continued to worsen over the next 16 hours. There were purple spots on his stomach, indicating blood clots. All were symptoms of meningococcal meningitis, a bacterial infection that causes swelling of the protective membranes that cover the brain and spinal cord.

Up to one in five people who survive meningitis can experience amputation, deafness, and brain and kidney damage. According to the National Meningitis Association, 10 to 15 percent die even with rapid treatment.

Springer was rushed to a hospital in Pittsfield, Massachusetts, and then quickly flown to another in Springfield, where his organs began to fail and his blood pressure dropped to near zero. He was given a 10 percent chance of survival.

He was taken to a Manhattan hospital where he underwent amputations in a medically induced coma that would last eight weeks.

After waking up, according to the 2003 New York Times article, he said to his father, “Dad, I don’t think I have fingers. I think I know about my legs too. “Mr. Springer remembered:” My wife and I looked at each other and said: ‘This is our new normal. ‘Because Nick is alive. He’s still Nick. “

Springer refused to wear prostheses or use an electric wheelchair. And he played wheelchair rugby relentlessly.

“At a very high level, it can be very violent and that’s what people like about it,” said his friend Scott Hogsett. “Who doesn’t want to see two people collide as hard as possible in a wheelchair?”

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State Dept. warns in opposition to journey to 80% of world. What to know

urbazon | E + | Getty Images

You may want to reconsider plans to travel abroad.

This is the recommendation from the U.S. Department of State, which this week updated its list of travel advice warnings Americans not to travel overseas to include about 80% of the world’s countries.

The State Department described the risks the ongoing Covid-19 pandemic poses for travelers as “unprecedented” and said in an April 19 statement that it “strongly recommends US citizens reconsider all travel abroad.” .

The department said its recommendations will now better reflect the travel health notices issued by the Centers for Disease Control and Prevention and will take into account factors such as the availability of tests in the country and travel restrictions for U.S. residents.

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“We believe the updated framework will help Americans make more informed decisions about the safety of international travel,” said a State Department official. “We are closely monitoring health and safety conditions around the world and will continue to update our destination-specific information for US travelers as conditions change.”

As a result of the update, 8 out of 10 nations around the world are rated “Level 4: Do Not Travel”. More than 100 countries have been rated at Level 4, including popular destinations such as Canada, France, Mexico and the UK

The nations that have not been downgraded to level 4 are mostly in East Asia, Oceania, and parts of Africa and the Caribbean.

While many countries in the updated list of Level 4 destinations have their own restrictions on foreign travel, some allow entry by air with proof of vaccination, negative Covid test, or other criteria. For example, Americans can travel to the UK as long as they test negative within 72 hours of their arrival. You will also need to fill out the documentation and quarantine it for 10 days.

Mexico, meanwhile, allows flight arrivals and has no testing requirements, though you may be screened or temperature checked at the airport.

The country has remained popular with Americans throughout the pandemic, despite testing or evidence of recovery requirements upon return to the US

For example, the Mexican state of Quintana Roo, home to resorts like Cancun, Playa del Carmen, and Tulum, welcomed nearly 1 million Americans from late 2020 to February.

The Department of State’s advisory system consists of four color-coded levels: Level 1 (blue) – Use normal precautions; Level 2 (yellow) – exercise increased caution; Level 3 (orange) – rethink the trip; and level 4 (red). The latter is reserved for countries with a “higher likelihood of life-threatening risks” and US citizens are advised not to travel there or leave unless it is safe to do so.

All international targets had been classified as Level 4 at the start of the pandemic in March last year, but the State Department lifted that recommendation in August. However, currently no listed nation is rated at level 1.

For the latest travel advice, visit the Department of State’s website at Travel.state.gov.

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The F.D.A. ended its advisable pause on the J.&J. vaccine, clearing the best way for states to make use of it once more.

She said the CDC spoke to health care providers for young women, including the American College of Obstetricians and Gynecologists. The hiatus and investigation into the rare disorder, she added, should give the public confidence in the vaccine safety monitoring system.

Almost 8 million doses of the Johnson & Johnson vaccine have now been given. There was less than one case per million doses in men and women aged 50 and over.

About 10 million doses or more of the Johnson & Johnson vaccine, made at the company’s factory in the Netherlands, are on shelves in the United States and could be used immediately. Several states, including Texas, Alabama, Utah, and Wisconsin, said they would likely follow the CDC and FDA recommendations once the decision was made.

Dr. Walensky said she had heard from the governors a keen interest in resuming the use of the shot.

“They were wondering why we were on pause and they were eager to have this back, to have an opportunity for a single-dose vaccine, for a once-in-a-lifetime opportunity,” she said.

The vaccine has immense potential benefits. If vaccinations are restarted for all adults, 26 to 45 cases of the bleeding disorder are expected in the next six months. This is based on a model developed by CDC scientist Dr. Sara Oliver presented at the meeting on Friday. However, 600 to 1,400 fewer Covid-19-related deaths would be expected over the same period.

The vaccine, which is easy to store and only requires one shot, is also great for hard-to-reach populations, including people who are at home, homeless, or incarcerated.

Other potential cases of the coagulation disorder, including some in men, are currently being investigated. Dr. Shimabukuro also mentioned a case that developed in a 25-year-old man who was taking part in a clinical trial of the vaccine.

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Single dose cuts an infection charge by 65%, examine finds

James Shaw, 82, receives Oxford University / AstraZeneca COVID-19 vaccine from advanced nurse Justine Williams on January 4, 2021 at Lochee Health Center in Dundee, Scotland, UK.

Andy Buchanan | Reuters

LONDON – A single dose of the Covid-19 vaccine from Oxford-AstraZeneca or Pfizer-BioNTech drastically reduces the risk of infection in adults of all ages, British researchers have found.

Two studies published on Friday analyzed more than 1.6 million nasal and throat swabs from 373,402 people between December and April. The data was collected as part of the ongoing Covid-19 infection survey carried out by Oxford University, the UK Office for National Statistics and the UK Department of Health and Welfare.

The researchers found that 21 days after a single dose of the Oxford-AstraZeneca or Pfizer-BioNTech vaccine, new Covid infections – both symptomatic and asymptomatic – had decreased by 65%.

Symptomatic infections decreased by 74% three weeks after a single dose of either vaccine, while asymptomatic cases decreased by 57%, the data showed.

A second dose of vaccine reduced the overall infection rate by 70%, reducing symptomatic Covid infections by 90% and asymptomatic cases of the virus by 49%.

The researchers compared these effects to the natural immunity obtained from infection with the virus.

However, they warned that the fact that vaccinated people could still be infected – even if those infections were mostly asymptomatic – meant “transmission possible”.

The study found that vaccines had a similar effect in reducing infection rates in adults of all ages. Their ability to reduce infection was also similar, regardless of whether the participants had long-term health conditions or not.

What about antibody resistance?

The scientists also looked at the effects of Covid vaccinations on participants’ antibody levels.

They found that older adults – especially those over 60 – who had never been infected with Covid had a lower immune response to a single dose of vaccine than those who had previously been infected with the virus.

Antibody responses to two doses of the Pfizer BioNTech vaccine were high in all age groups. The data showed that older adults were able to achieve antibody levels similar to those who received a vaccine dose after a previous Covid infection.

Too few people in the UK had received two doses of the Oxford AstraZeneca vaccine for researchers to assess the effects on antibody response. However, it was found that immune responses to a first dose differed between the Oxford AstraZeneca vaccine and the Pfizer BioNTech vaccine.

Antibody levels rose more slowly after a single dose of the Oxford-AstraZeneca vaccine than after the Pfizer-BioNTech alternative. However, after a dose of the latter, antibody levels fell more rapidly, especially in older adults, so patients achieved antibody levels similar to those seen after an initial dose of the Oxford-AstraZeneca vaccine.

Although immune responses differed between age groups, the scientists emphasized that there was no group that did not respond to either vaccine. However, a small number of people – less than 5% – had poor immune responses to both vaccines.

Important to get the second dose

The Oxford-AstraZeneca vaccine has been approved for use in the UK, India and several other countries, but has been temporarily suspended in some markets amid concerns that it could be linked to rare blood clots. Global health officials have stated that the benefits of giving the vaccine continue to outweigh the risks.

The WHO recommends an interval of eight to 12 weeks between the first and second dose of the Oxford AstraZeneca vaccine.

The Pfizer BioNTech vaccine is also given in several countries, including the United States. The U.S. Centers for Disease Control and Prevention recommends receiving a second dose of the vaccine three weeks after the first.

In February, the UK started a study to see if mixing doses of the Oxford-AstraZeneca and Pfizer-BioNTech vaccines could be effective.

Sarah Walker, professor of medical statistics and epidemiology at Oxford University and chief investigator and academic director of the Covid-19 infection survey, said Friday that scientists are still not sure how strong and how long an antibody response is. was needed for long-term protection against Covid.

David Eyre, associate professor at Oxford University’s Big Data Institute, added that the results released on Friday highlighted the importance of a second dose of vaccine for increased protection.

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Research Finds Many With Delicate Covid Have New Illnesses Months Later

Most adults who test positive for the coronavirus do not need to be hospitalized, but usually seek medical help in the months that follow. Two-thirds of those who do this develop a state of health that they did not have before.

These are the findings of a study conducted by researchers from the Centers for Disease Control and Prevention and Kaiser Permanente, which included approximately 3,171 members of the Kaiser Permanente Georgia Integrated Health System. More than half were black.

The message for patients is that even with mild Covid-19, “months after initial diagnosis, new or persistent symptoms may appear,” said Dr. Alfonso C. Hernandez-Romieu, Infectious Disease Specialist at the CDC and the lead author of the study. “And it’s important that people make sure they see their doctors,” he said to express their concerns.

“It is equally important,” he added, “that clinicians recognize that there can be these long-term effects and really make sure that they validate patients, treat them with empathy, and try to do their best to help them.”

Doctors need to monitor patients for Covid-19-related complications that can be very serious, such as blood clots, he said.

The study did not compare patients who tested positive for the coronavirus with patients who did not. As a result, the authors couldn’t tell whether people who recovered from mild Covid-19 cases made more doctor visits than those who never had the virus.

However, two-thirds of patients with mild illness sought medical help one to six months after their Covid-19 diagnosis, and about two-thirds of patients seeking treatment were diagnosed with an entirely new condition. The new diagnoses included cough, shortness of breath, heart rate disturbances, chest or throat pain, and fatigue, “which are likely to be persistent Covid-19 symptoms,” the study said.

Those who received more medical attention included adults ages 50 and older, women, and those with underlying health conditions. Black adults were also slightly more likely to seek care than others. Overall, however, the authors found that the number of visits decreased over time.

The potential for long-term complications, even after a mild course of the disease, underscores the need for preventive measures and vaccinations, said Dr. Hernandez-Romieu.

“There’s a lot we don’t know about post-Covid conditions,” he said. “Even if the majority of people don’t have severe Covid or end up in hospital, the potential for long-term health effects is really important.”

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U.S. could by no means attain ‘true herd immunity,’ says Dr. Scott Gottlieb

Dr. Scott Gottlieb told CNBC on Friday he believes the United States may struggle to achieve “true herd immunity” to Covid, suggesting there will be coronavirus infections in the years to come.

However, the former commissioner of the U.S. Food and Drug Administration stressed that new cases alone should not be the metric that gets the greatest focus as more people are vaccinated against Covid.

“I don’t think we should think about achieving herd immunity. I don’t know that we will ever achieve real herd immunity where this virus simply no longer circulates,” said Gottlieb at “Closing Bell”. “I think it will always be circulating at low levels. That should be the goal of keeping virus levels down.”

Gottlieb, who serves on the board of directors at Covid vaccine maker Pfizer, expects the US to make significant strides toward that goal in the coming weeks.

“I think we’ll reach a point this summer where the spread of this virus will be extremely low. We’ll likely see the cases collapse pretty soon sometime in May. We’re already seeing it in parts of the country.” said Gottlieb.

Even so, according to Gottlieb, the US could flatten about 5,000 to 10,000 new coronavirus cases per day this summer, partly due to how commonplace Covid testing has become. “We’re going to see a lot of asymptomatic and mildly symptomatic infections,” he said.

“I think the bottom line is that vaccination is dramatically reducing the susceptibility of the American population, and that’s what we really need to focus on,” said Gottlieb, who headed the FDA in the Trump administration from 2017 to 2019.

“We shouldn’t just focus on cases. There will be cases, but we should focus on how many people are hospitalized and get this virus. That will drop dramatically when we introduce the vaccines,” he said.

Public health experts have stressed throughout the pandemic that the more people in a population have immunity protection for a particular virus, the less easily it will spread. While vaccines have been shown to reduce transmission, Gottlieb isn’t the first to point out that achieving permanent herd immunity is likely to be a challenge for Covid.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, has estimated that 75% to 85% of the population vaccinated against Covid would create an “umbrella” of immunity. “That could even protect the vulnerabilities that weren’t vaccinated or where the vaccine wasn’t effective,” he told CNBC in December, shortly after the FDA approved Pfizer’s emergency use of Pfizer.

About 41% of the US population have now received at least one dose of Covid vaccine, and 27.5% are fully vaccinated, according to the latest information from the Centers for Disease Control and Prevention. CDC data show that a total of more than 220 million doses were administered.

Gottlieb previously said that the US could theoretically get to a point where Covid, like other diseases like polio and smallpox, will be eradicated. “It is possible. We do not seem ready to do this and take the collective action that is required,” he told CNBC on April 16.

“It will take people who practice a civic virtue to get vaccinated, even if they individually feel low risk of infection,” he said. “Because even if they are at low risk, they can still get and transmit the infection, and you cannot eradicate a disease where you have a significant contingent of people who will continue to catch and transmit it.”

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotech company Illumina. He is also co-chair of Norwegian Cruise Line Holdings and Royal Caribbean’s Healthy Sail Panel.

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A brand new research hints at a purpose the J.&J. and AstraZeneca vaccines could trigger blood clots in uncommon circumstances.

An advisory group from the Centers for Disease Control and Prevention has recommended that the Johnson & Johnson Covid-19 vaccine hiatus be lifted for all adults while also putting up a warning sign about a rare but dangerous blood clot disorder. However, a central mystery remains: how could a vaccine given to nearly eight million people cause the side effect in just a few of them?

There’s no clear answer yet, but Dr. Andreas Greinacher, a researcher at the University Medical Center Greifswald in Germany, leads an attempt to find out. Speaking at a news conference on Tuesday, he said he had an agreement with Johnson & Johnson to study the components of the vaccine to see if it could interfere with normal blood clotting under certain rare conditions.

“We just agreed that we’d like to work together,” he said.

It is possible, said Dr. Greinacher that the Johnson & Johnson vaccine can cause rare side effects through the same process that he suspects is responsible for similar side effects of the AstraZeneca vaccine. The main component of both vaccines are harmless viruses called adenoviruses, which invade human cells and deliver a coronavirus gene that later triggers an immune response.

On Tuesday, Dr. Greinacher and his colleagues published a report on how the AstraZeneca vaccines can trigger the side effect. The study has not yet been published in a scientific journal.

The scientists found that components of the AstraZeneca vaccine can adhere to a protein that releases platelets when blood clots form. These lumps of molecules could be viewed by the body as foreign invaders, the scientists speculated, triggering a cascade of reactions that turn platelets into dangerous clots.

Dr. Paul A. Offit, a vaccines expert at Philadelphia Children’s Hospital who was not involved in the study, found Dr. Greinacher fascinating, but far from the final word. “It throws a lot of opportunities,” he said.

Dr. Offit said it was not clear which of the many factors the researchers looked at could explain the rare blood clots in people vaccinated with AstraZeneca’s doses. “It’s like taking a sip from a fire hose,” he said.

At a press conference on Tuesday, Dr. Greinacher said the research could reveal ways the AstraZeneca vaccine can lower the risk of blood clots or treat the side effects. However, he stressed that the small risk of these side effects was outweighed by the protection that vaccines like AstraZeneca offer against Covid-19.

“Not being vaccinated is far more dangerous than being vaccinated and at risk for this adverse drug reaction,” he said.

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CDC panel recommends resuming use

An advisory panel to the Centers for Disease Control and Prevention on Friday recommended the US resume vaccine from Johnson and Johnson Covid-19, with the benefits outweighing the risk.

Panel members did not recommend U.S. regulators limit use of the vaccine based on age or gender, but suggested that the FDA consider adding a warning to women under the age of 50.

The recommendation, accepted 10: 4 with one abstention by the CDC Advisory Committee on Immunization Practices, will pave the way for US regulators to end their recommended break in the use of the J&J shot earlier this weekend.

The single shot is an important tool for delivering life-saving vaccines to hard-to-reach places where reliable cooling may not be available, e.g. A second dose is given in tribal, poorer areas, and rural communities, and for people who may not be able to return, US health officials say.

The committee, an external panel of experts advising the CDC, decided last week to postpone a decision on the vaccine while officials continued to study cases of six women aged 18 to 48 who had combined cerebral venous sinus thrombosis (CVST ) developed with low platelets within about two weeks of receiving the shot.

The Food and Drug Administration and CDC on April 13 urged states to temporarily suspend use of J & J’s vaccine “out of caution” following reports of the rare blood clots. Within hours of the alert, more than a dozen states, as well as a few national pharmacies, suspended vaccinations with J & J’s vaccine, with some replacing scheduled appointments with either the Pfizer or Moderna vaccine.

Prior to Friday’s vote, the committee debated whether to recommend against J & J’s use of the vaccine or recommend it to U.S. regulators enforcing a warning label. The committee also considered limiting use of the vaccine based on age or other risk factors.

CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from draining from the brain and can eventually lead to bleeding and other brain damage. The blood clots are similar to those reported in some people who received the Covid-19 vaccine from AstraZeneca.

During the meeting on Friday, Dr. Tom Shimabukuro, a CDC official, said there have been no reports of the condition of those who received the Pfizer BioNTech mRNA vaccine. There have been three reports of CVST in patients receiving the Moderna vaccine, he said, even though the patients did not have the low platelet levels seen in the J&J recipients.

Platelets help the body form blood clots to heal wounds. US health officials warned against a treatment such as blood-thinning heparin in patients with low platelets, which could make their condition worse.

Rare blood clots with low platelets occur in women aged 18 to 49 at the rate of 7 per 1 million vaccinations for the J&J shot and 0.9 per 1 million in women aged 50 and over. This is evident from a slide presented at the CDC panel meeting. CDC has confirmed a total of 15 cases of rare blood clots, including 12 women who developed blood clots in the brain. Three women have died and seven remained in the hospital, according to slides.

There are no confirmed cases in men, although officials have stated that they are looking at potential additional cases.

Dr. Michael Streiff, a hematologist at Johns Hopkins University Medical School, said the condition is very rare under normal circumstances. “I can tell you from my experience treating these patients that I’ve just never seen it before,” he told the committee during a presentation on Friday.

A CDC model presented at the meeting showed that not resuming use of J & J’s vaccine would delay immunization for all adults who wish to receive the shots by 14 days.

J&J executives told the committee that the vaccine’s benefits still outweighed the risks, adding that the shots would prevent death and hospitalizations. They proposed a new warning label for the vaccine explaining the risk of blood clots.

“We could expect that if 1 million people in the US were vaccinated with the J&J single-dose vaccine, there would be more than 2,000 deaths and 6,000 fewer hospital stays associated with Covid,” said Dr. Joanne Waldstreicher, Chief Medical Officer of J & J.

Earlier this week, J&J announced that it would restart its vaccine rollout in Europe after regulators there backed the single vaccine by recommending adding a warning to the label. The European Medicines Agency has examined all available evidence, including reports from the United States.

Last week, US health officials announced that the hiatus from using the vaccine would only be a few days, depending on what they learned from investigating the cases

Before the CDC meeting, Dr. Wilbur Chen, a member of the committee, told CNBC that he saw “a great amount of evidence” that the benefits of the J&J vaccine still outweighed its risks.

“I think we are ready to use this vaccine. We had to take an important pause to review this safety information in order to consider the risks. But I think there is a great amount of evidence of this to be of benefit that risk far outweighs that, “Chen, a professor at the University of Maryland Medical School, told Worldwide Exchange.

This is a developing story. Please try again.

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A C.D.C. panel discusses new uncommon clot circumstances in J. & J. shot recipients and the way total threat appears to be very low.

Twelve of the 15 women in the confirmed cases developed blood clots in the brain. Many had blood clots elsewhere as well. Initial symptoms, which include a headache, usually begin six or more days after vaccination, said Dr. Shimabukuro. As the disorder develops, it can cause increased headaches, nausea and vomiting, abdominal pain, weakness in one side of the body, difficulty speaking, loss of consciousness, and seizures.

Dr. Shimabukuro found that seven of the women were obese, two had hypothyroidism, two had high blood pressure, and two were using oral contraceptives. It is not yet clear whether any of these factors could increase the risk of developing a coagulation disorder after vaccination.

Patients’ symptoms closely resemble a rare syndrome that can be caused by heparin, a widely used blood thinner, said Dr. Michael Streiff, a hematologist at Johns Hopkins University, joined the panel. Heparin, which could typically be used to treat blood clots, shouldn’t be used to treat these patients, he said.

Doctors should consider the rare coagulation disorder in patients who have blood clots and low platelet counts within three weeks of receiving the Johnson & Johnson vaccine, said Dr. Streiff.

“Knowing that this syndrome exists will help improve outcomes,” he said.

The committee could recommend Johnson & Johnson put up a formal warning label about the side effects, as the company has done in the European Union. About 10 million doses or more of the vaccine, which is manufactured at the company’s facility in the Netherlands, are on shelves in the United States and could be used immediately.

The meeting comes as the federal government is also investigating issues at a Baltimore factory that is slated to meet the country’s demand. Emergent BioSolutions, the operator of the facility, has manufactured tens of millions of doses of Johnson & Johnson’s vaccine, but they cannot be distributed until regulatory agencies certify the facility.

After Emergent had to discard up to 15 million potentially contaminated doses of the vaccine last month, federal regulators conducted an inspection that found a number of problems, including the risk of other lots being contaminated.