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Moderna Seeks Full F.D.A. Approval for Covid Vaccine

Moderna was the next pharmaceutical company to file with the U.S. Food and Drug Administration on Tuesday for full approval of its coronavirus vaccine for use in people aged 18 and over.

Last month Pfizer and BioNTech filed with the agency for full approval of their vaccines for use in people 16 years and older.

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing filing,” said Stéphane Bancel, CEO of Moderna, in a statement.

Moderna’s emergency vaccine was approved in December, and by Sunday more than 151 million doses had been administered in the United States, according to the Centers for Disease Control and Prevention.

“I think there are a lot of people on the fence who are worried that things are moving too fast and about possible side effects,” said Dr. William Schaffner, National Foundation for Infectious Diseases medical director and vaccine expert. “But those concerns are allayed as they see more of their friends and acquaintances celebrating their vaccination.”

Jan Hoffman contributed to the coverage.

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Moderna applies for full FDA approval

A medical worker from Parrish Medical Center holds a vial of the Moderna COVID-19 vaccine at a drive through vaccination clinic for employees of Port Canaveral, workers at local hotels and restaurants, and residents of the Port Canaveral community.

Paul Hennessy | LightRocket | Getty Images

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the shots directly to consumers.

The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data. Over 100 million of the shots have already been administered, according to data compiled by the Centers for Disease Control and Prevention.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

The FDA approval process is likely to take months.

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, the company said Tuesday.

Once companies submit applications to the FDA, agency scientists painstakingly look through the clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “They want to make sure that the company has fairly and accurately displayed all those data,” he said.

Full U.S. approval will allow Moderna’s vaccine to stay on the market once the pandemic is over and the U.S. is no longer in a public health emergency, said former FDA commissioner Dr. Robert Califf. It also sets the stage for the company to begin advertising the shots on TV and other media platforms, he said, which is not permitted under an EUA.

Moderna is the second company to seek full U.S. approval of its Covid vaccine. On May 7, Pfizer and partner BioNTech said they started the process of seeking full approval for their vaccine for use in people 16 and older in the U.S.

Moderna’s vaccine, which requires two doses given four weeks apart, has been found to be more than 90% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose. The company said in an earnings report on May 6 that it planned to begin the process of seeking full FDA approval soon.

In addition to seeking full approval, the company is also expected to ask the FDA to expand the emergency use of its Covid vaccine for adolescents as young as 17. The company said last week its shots were found to be 100% effective in a study of kids ages 12 to 17.

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FDA official says coronary heart challenge presumably linked to pictures is uncommon

A healthcare worker administers a dose of a Pfizer-BioNTech Covid-19 vaccine to a child at a pediatrician’s office in Bingham Farms, Michigan, U.S., on Wednesday, May 19, 2021.

Emily Elconin | Bloomberg | Getty Images

A heart inflammation condition in adolescents and young adults who received Covid-19 vaccines appears to be very rare and it remains unclear if the issue is actually related to the shots, the Food and Drug Administration’s top vaccine regulator, Dr. Peter Marks, said Thursday.

The Centers for Disease Control and Prevention’s vaccine safety group said last week it was looking into a condition called myocarditis, which is an inflammation of the heart muscle, in a “relatively few” people who received Covid vaccinations.

Myocarditis can affect one’s heart muscle and heart electrical system, “reducing its ability to pump and causing rapid or abnormal heart rhythms,” according to the Mayo Clinic.

The cases were predominantly in adolescents and young adults and usually occurred within four days after getting the shot, according to the CDC. The condition was seen more often in men and most cases appear to be mild, the agency said, though officials are following up with the patients.

“We still don’t know whether this is truly related to the vaccine,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a virtual Q&A event with the COVID-19 Vaccine Education and Equity Project.

The CDC is coordinating its investigation with the FDA, which recently authorized the Pfizer-BioNTech vaccine for adolescents ages 12 to 15. The vaccine has been available for Americans 16 and up since December. Vaccines from Moderna and Johnson & Johnson are available to those 18 and older.

Health experts say finding rare side effects once a vaccine or drug is administered to the general population is common and if myocarditis turns out to be related to the Covid vaccine, the risk is negligible when compared with the risks of being infected with Covid-19.

Marks, who has been at the FDA for nearly a decade, added Thursday that the “handful” of cases reported have been “very mild, lasting a day or two” and usually happened after a second dose.

“My kids are a little older, but I wouldn’t hesitate to vaccinate my children, just because this is a pretty rare finding and we really don’t know yet if it’s truly related” to the vaccines, he said.

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World News

Moderna says shot is 100% efficient in teenagers, plans to hunt FDA OK in June

A young man receives his Covid-19 vaccination in a vaccination clinic. People are receiving the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | LightRocket | Getty Images

Moderna said Tuesday that its Covid-19 vaccine was 100% effective in a study in adolescents ages 12 to 17. This makes it the second attempt after Pfizer that has demonstrated a high level of effectiveness in younger age groups.

The company plans to ask the Food and Drug Administration to expand emergency use of its Covid-19 vaccine to teenagers early next month. If approved, it would likely dramatically increase the number of recordings available to middle and high school students before the next school year. Pfizer and German partner BioNTech were approved to use their vaccine for 12 to 15 year olds earlier this month.

“We are encouraged that mRNA-1273 is highly effective in preventing COVID-19 in adolescents,” said Stephane Bancel, CEO of Moderna, in a press release. “We continue to strive to do our part to end the COVID-19 pandemic.”

The two-dose vaccine, given four weeks apart, is already approved for adults.

The phase 2/3 study the company cited on Tuesday included more than 3,700 teenagers. No cases of Covid-19 were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to the company.

No significant safety concerns have been identified to date, with side effects generally in line with a previous study in adults, the company said. The most common side effects after the second dose were headache, fatigue, muscle pain, and chills, Moderna said.

The new data comes less than three weeks after the company announced in an earnings report that early data showed the shot was 96% effective against Covid in teens ages 12-17. These data were based on those who had received at least one dose of the vaccine.

The company said Tuesday that the shot in the study was 93% effective after one dose. For this it used the definition of Covid-19 from the Centers for Disease Control and Prevention, which only requires one symptom and a positive Covid test.

US regulators are expected to approve Moderna’s application for teenage use. The approval process could take about a month, in time for some summer activities and fall Classes if Moderna submits the data by the beginning of June. Pfizer and BioNTech, for example, filed for expanded use of their shot in teenagers on April 9th ​​and were approved by the FDA on May 10th.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to medical experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity, and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

According to health experts, vaccinating children can also accelerate the return of personal learning and enable after-school activities such as sports, arts, and other personal activities after school.

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Business

Emergent CEO says FDA is holding over 100 million J&J Covid vaccine doses for additional testing after botched doses

Robert Kramer, CEO of Emergent BioSolutions

Scott Mlyn | CNBC

The FDA is holding over 100 million vaccine doses of Johnson & Johnson Covid-19 for further testing after the agency found multiple security breaches at the Emergent BioSolutions facility that helped make the gunshots, said Robert Kramer, CEO of Emergent, on Wednesday to lawmakers.

The US hired J&J to run the Baltimore facility last month after learning that Emergent, a federal company that made key ingredients for J&J and AstraZeneca, contaminated the two shots. Kramer testified before House lawmakers Wednesday that the conditions at the Baltimore plant allegedly were responsible for the destruction of millions of J&J Covid-19 shots.

During the hearing before the House Select Coronavirus Crisis Subcommittee, Rep. Steve Scalise, R-La., Kramer asked how many doses of J&J vaccine are held by the Food and Drug Administration but are not contaminated.

“There are a significant number of doses that we have made. Again we are making the mass drugs,” Kramer told lawmakers. “It has been reported by a number of news outlets that there are likely over 100 million doses of the J&J vaccine we make that are now under FDA review for possible release and availability.”

Kramer later stated that the regulator requested additional testing of the cans.

“The FDA, to the best of my knowledge, evaluates the doses made for mass drug use, most of which were provided to J&J,” Kramer said. “As far as I know, there was a request for additional testing on all of these lots and doses that J&J had made available to the FDA. And they are currently being evaluated.”

J&J declined to comment on the number of doses. The FDA did not immediately respond to a request for comment.

This is a developing story. Please try again.

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FDA clears use in children ages 12 to 15

The Food and Drug Administration on Monday approved Pfizer and BioNTech’s motion to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency so states can vaccinate middle school students before the fall.

The U.S. agency, which grants the use of the shot in teenagers, will also accelerate the country’s efforts to fight infection, say public health officials and infectious disease experts.

The two-dose vaccine is already approved for use in people aged 16 and over. The Centers for Disease Control and Prevention’s Vaccine Advisory Board scheduled a meeting on Wednesday to review the recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

Acting FDA Commissioner Dr. Janet Woodcock said the decision “moves us closer to a return to a sense of normalcy and an end to the pandemic”. She assured parents that the agency “did a rigorous and thorough review of all available data” before approving it for teenage use.

The companies announced in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, said in April that the US could start vaccinating older children against Covid-19 from the fall, while elementary school-age children may get their shots early next year.

The vaccine is given in two doses three weeks apart, according to the FDA, with the same regimen according to the FDA for people aged 16 and over.

FDA approval for children under the age of 12 could come in the second half of this year. In a presentation to coincide with the company’s earnings release on May 4th, Pfizer expects to file for approval of its toddler vaccine in September and toddler vaccine in November. The filing process for full FDA approval for people aged 16 and over has already begun, the company announced on Friday.

In late March, Pfizer and BioNTech started a clinical trial testing their vaccine in healthy 6-month-old to 11-year-old children. Moderna and Johnson & Johnson, whose vaccines are approved for people aged 18 and over, are also testing their recordings in younger age groups.

The FDA’s announcement also comes in the context of President Joe Biden’s push to reopen schools for personal learning. Biden’s government has already announced that it will invest $ 10 billion in Covid testing for schools to accelerate returns to face-to-face courses across the country.

Vaccinating children can also give the green light to after-school activities such as sports, arts, and other personal activities.

While parents feel relieved that their children can be vaccinated, some health experts have questioned whether doses should be kept for children who are considered less at risk for serious illness while leaving vulnerable people around the world unprotected.

Dr. Craig Spencer, director of global health and emergency medicine at Columbia University Medical Center, said there need be no either-or choice between vaccinating children and distributing shots to the rest of the world. The US can do both, he said. But he’s frustrated that the US has stopped focusing on getting the rest of the world vaccinated.

“If I were to ask you whether a 12 year old with no medical problems or a 57 year old healthcare worker who cares for Covid patients every day should be vaccinated, the answer is very clear, right?” he said. “Why does this calculation change when it comes to a health worker from another country?”

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Health

FDA Authorizes Pfizer-BioNTech Vaccine for Kids 12 to 15

Vaccinating children is vital to boost population immunity and contain the spread of the coronavirus. Although children spread the virus less efficiently than adults, they make up about 23 percent of the population.

Experts have said the country is unlikely to reach “herd immunity” – the point where virus transmission essentially comes to a halt – but vaccinating children will be important to get as close as possible .

14-year-old Ty Dropic, one of the study participants, urged others his age to get vaccinated so they can build widespread immunity and protect themselves. He had no side effects, which led him to suspect that he was on the placebo. If this turns out to be the case, he plans to be vaccinated as soon as possible.

“I know it can be scary, but it really isn’t as bad as it seems,” he said. “If you get Covid it will be a lot worse than being stuck with a needle for two seconds.”

Ty’s three siblings, ages 8, 10, and 16, are also participating in vaccination trials for their age groups. Your mother, Dr. Amanda Dropic, a pediatrician in northern Kentucky, said most of the parents in her practice were eager to get their children vaccinated to help them regain some semblance of normalcy.

“The anxiety and depression that we see in children, the social delays, have been enormous,” she said.

Dr. Dropic said her children understood the risks and were willing to volunteer because they saw it as a civic duty. Every drug available today came about because “someone was ready to go first,” she added.

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FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Subsequent Week

WASHINGTON – The Food and Drug Administration is preparing to approve the use of the Pfizer BioNTech coronavirus vaccine in adolescents ages 12-15 by early next week, according to federal officials familiar with the agency’s plans, and opens the US vaccination campaign to millions more people.

Some parents have counted down the weeks since Pfizer announced results of its teenage study showing the vaccine was at least as effective in this age group as it was in adults. Vaccinating children is key to increasing immunity in the population and reducing the number of hospitalizations and deaths.

The approval in the form of an amendment to the existing emergency approval for the Pfizer vaccine could come as early as later this week. If so, the Centers for Disease Control and Prevention’s vaccine advisory board is expected to meet the following day to review the clinical trial data and make recommendations on the use of the vaccine in adolescents.

The enlargement would be a major development in the country’s vaccination campaign and welcome news for some parents looking to protect their children during summer activities and before the start of the next school year. This is also another challenge for policy makers who have difficulty vaccinating a large percentage of adults who are reluctant to get the shot. Many more may refuse to vaccinate their children.

Pfizer reported a few weeks ago that none of the adolescents in the clinical trial who received the vaccine developed symptomatic infections, a sign of significant protection. The company said volunteers produced strong antibody responses and had roughly the same side effects seen in people aged 16-25.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, said she was unable to comment at the time the agency made the decision.

“We can assure the public that we are working to look into this request as quickly and transparently as possible,” she said.

Over 100 million adults in the US have been fully vaccinated. However, approval would come in the middle of a delicate and complex push to reach the 44 percent of adults who have not yet received a single shot.

With much of the world demanding the surplus of US-made vaccines, the use of the Pfizer BioNTech shot in adolescents will also raise questions about whether care should be targeted at an age group largely spared heavy vaccines seems Covid19.

“I think we need to have a national and global conversation about the ethics of our vaccinated children, who are at low risk of serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying “Said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

Updated

May 3, 2021, 8:53 p.m. ET

President Biden has come under increasing pressure to shed some of the country’s vaccine supplies. Some federal officials have also urged the government to decide soon how much vaccine is needed so that the doses do not expire or be shipped to the states and not used. The federal government has bought 700 million doses of three state-approved vaccines to be dispensed before the end of July, well in excess of what would be required for any American.

White House officials said last week that the intention is to make up to 60 million doses of the AstraZeneca vaccine available to other countries as long as federal regulators deem the doses to be safe. The vaccine has not yet been approved by American regulators. However, global health groups and public health experts said engagement was not enough.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher investigating vaccine use and reluctance, said the United States should donate any surplus Pfizer BioNTech shots – and any surpluses from other manufacturers – to India and other countries that are had severe outbreaks and asked for help.

“From an ethical point of view, we shouldn’t give people like them priority over people in countries like India,” said Dr. Limaye about teenagers.

If the United States continues its supply of Pfizer-BioNTech, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that requires more individualized local contact.

“We still have to move past hesitant adults and start at the same time maybe 14 or 15,” said Dr. Limaye. “But the priority should still be adults.”

The current vaccine supply in the United States is substantial. As of Monday, about 65 million doses had been dispensed but not given, according to the CDC, including 31 million doses of the vaccine from Pfizer-BioNTech, nearly 25 million doses from Moderna, and 10 million doses from Johnson & Johnson

The Pfizer and Moderna vaccines each require two doses. Pfizer is approved for ages 16 and up, Moderna for ages 18 and over.

Dozens of millions more Pfizer BioNTech cans – about three weeks long, according to a federal official – have been made and are in various stages of readiness. They wait for the final tests before they are shipped.

Moderna expects results from its own clinical study in adolescents aged 12 to 17 years old soon, followed by results in children aged 6 months to 12 years later this year.

The approval of the Food and Drug Administration should ease the concerns of middle and high school administrators scheduled for the fall. If students can be vaccinated by then, it could lead to more normal gatherings and allow administrators to plan further ahead in the academic year.

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FDA to suggest ban on menthol-flavored cigarettes, with trade prone to problem

The Food and Drug Administration announced Thursday that it would propose a ban on menthol-flavored cigarettes in the US, which would mean a big blow to future tobacco sales.

Menthol is the last permitted flavor for cigarettes. According to the FDA, menthol cigarettes were disproportionately used by teenagers, black people and low-income groups. The vast majority of black smokers prefer menthol brands of cigarettes, and black men currently have the highest rates of lung cancer in the country.

“With these actions, the FDA will help significantly reduce initiation of adolescents, increase the likelihood of smoking cessation among current smokers, and eliminate health gaps that occur among color communities, low-income populations, and LGBTQ + people, all of which are far more likely are to use these tobacco products, “said Janet Woodcock, acting FDA commissioner, in a press release.

This decision was in response to a 2013 citizen application. A court had ordered a response from the agency by Thursday.

Years until implementation

However, Jefferies analyst Owen Bennett said that proposal would take years to reach a conclusion, as it would need sufficient evidence from both sides, which could be difficult.

“If we see a proposed rule for menthol, it could take years to reach the final rule as a waterproof evidence package would have to be put together … the FDA itself has said in the past that there was not enough evidence,” he said in a report, adding that large tobacco companies might strike back in response, which would mean more time.

This decision was made after years of deliberation by public health officials to help smokers make the transition to less harmful practices such as non-flammable products or smoking cessation altogether.

Menthol cigarettes make up about a third of all cigarettes sold in the United States. The leading brands are Newport, owned by British American Tobacco’s RJ Reynolds, and Kool, owned by Imperial Tobacco’s ITG Brands.

British American Tobacco controls a whopping 66% stake in the menthol market, while Altria has a 26% stake and Imperial an 8% stake, according to a report by Bernstein analyst Callum Elliott.

Altria’s business is less exposed to menthol sales. Elliott estimates that only about 17% of its volume falls into this category. It would be a bigger blow to British American as more than half of its cigarette volume comes from that category, Elliott said.

Imperial Brands said the FDA’s decision was “disappointing” but expected. According to Elliott, menthol makes up about 30% of its volume.

“We believe the rulemaking process will show that there is no clear scientific evidence to support a menthol and flavor ban at the federal level. We hope the FDA will comply with the law and prioritize sound politics and science over political pressure,” said the enterprise.

‘Unintended Consequences’

Marlboro cigarette maker Altria has warned of the possibility of a ban that could create an illegal market.

“We share a common goal of switching adult smokers from cigarettes to potentially less harmful alternatives, but the ban is not working,” Altria said in a statement. “The criminalization of menthol will have serious unintended consequences.”

Reynolds and his parent company British American Tobacco were not immediately available for comment.

The argument against flavors

If implemented, the proposal would be of great benefit to anti-tobacco advocates who have long seen flavored cigarettes as a way for consumers to become acquainted with smoking.

Tobacco product smoking is the leading cause of preventable death in the country, according to the FDA. There are plans to introduce product standards to eliminate menthol in cigarettes within the next year, as well as to eliminate all signature flavors, including menthol, in cigars.

According to the Centers for Disease Control and Prevention, fourteen percent of all American adults smoked cigarettes in 2019. Although smoking rates are similar between black and white populations, black smokers are less likely to quit, which some have attributed to the menthol taste. The mint taste of menthol cools the throat and makes it easier for smokers to tolerate the tobacco taste.

The FDA cited a tobacco control study indicating that a ban could help smokers quit smoking. It pursued behavior after menthol bans were introduced in Canada. The FDA estimates a US ban could cause an additional 923,000 smokers, including 230,000 African Americans, to quit in the first 13 to 17 months.

Last week, the Biden government also announced it was considering limiting nicotine levels in cigarettes. This is another step that the FDA has been pushing for years. However, today’s announcement on menthol cigarettes makes no mention of a reduction in nicotine levels.

Altria and British American Tobacco, Reynolds’ parent company, lost nearly 2% in midday trading.

Read the FDA statement here.

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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.