Jimmy Kimmel Urges People to Get COVID-19 Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

On Tuesday’s episode of Jimmy Kimmel Live, host Jimmy Kimmel encouraged people to get a COVID-19 vaccine and featured a video of doctors and nurses across the country who talked about their experiences.

More than 100 million adults in the U.S. are now fully vaccinated, according to the latest CDC tally. Kimmel applauded the number but then pointed out that 26% of adults say they don’t plan to get a vaccine.

“I get that people are skeptical of politicians or celebrities telling them what to do, but we should listen to doctors,” he said. “These are men and women who have been on the front lines of this thing, risking their lives to save ours, and they’re frustrated. Who could blame them?”

In a humorous “public service announcement,” Kimmel asked several health care workers to give advice to those who are on the fence about whether they want to take a vaccine.

“If we don’t get more people vaccinated, we could see new mutations of this virus and go through this all over again,” Kimmel said. “Pay attention, because this is important.”

During the brief video segment, six doctors and nurses spoke about their decades-long work in the medical field. The messaging took on a comedic tone, with the guests pointing out facts about the human body and their experiences delivering babies, performing operations, or looking at their friends’ skin conditions during parties.

They also humorously emphasized the importance of listening to trained medical experts, not rumors on social media sites.

“Your friend from high school, who sells jewelry, she posted it?” a nurse said.

“You heard what on whose podcast?” a doctor said.

“Is he a doctor? No? Scientist? No?” another doctor said.

“Can he name one of the ingredients in the vaccine?” a critical care nurse said.

“And that polio shot we gave your kid, and then your kid not getting polio? Well, those two things are related,” another doctor said.

“How about this? You do your job. I’ll do mine,” a nurse said.

“Get the vaccine,” they all said. “And tell your friend on Facebook to stick to jewelry.”

The Kimmel audience erupted into applause and cheers as the final title card read: “Brought to you by people who are smarter than we are.”

As of Wednesday, the U.S. has shipped more than 321 million COVID-19 vaccines, and 148 million people have received at least one dose, which makes up about 57% of the adult population. More than 41% of adults are considered fully vaccinated, according to the CDC.

Sources

Jimmy Kimmel Live: “Message for People Who Don’t Want the COVID Vaccine.”

CDC: “COVID-19 Vaccinations in the United States.”

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FDA Set to OK Pfizer Vaccine in Younger Teens

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The FDA could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.

In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.

The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.

Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.

A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.

The risk for severe illness and death from COVID-19 rises with age.

Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.

Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.

As new variants of the coronavirus circulate in the U.S., some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recent dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.

Beyond individual protection, vaccinating children and teens has been seen as an important to achieving strong community protection, or herd immunity, against the new coronavirus.

If the FDA expands the authorization for the Pfizer vaccine, the CDC’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the U.S.

Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.

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EU Official Warns of Risks of Disjointed COVID Vaccine Records

BRUSSELS (Reuters) – European Union countries introducing their own COVID vaccination certificates would have to grapple with a myriad of disjointed systems if the bloc fails to build a shared one, a senior official said on Wednesday.

The EU is pushing to have a shared digital health pass to allow tourists to travel freely this summer. But discussions are not yet settled on costs, data and privacy issues, as well as technical and medical aspects of the new system.

“If we can deliver politically, the technical solution will be ready in time. If we don’t, we risk fragmentation across Europe, with a multitude of possibly incompatible national solutions,” EU Justice Commissioner Didier Reynders said.

“We would risk having a variety of documents that cannot be read and verified in other member states. And we risk the spread of forged documents, and with it, the spread of both the virus and the mistrust of citizens,” he told the European Parliament.

Tourism-reliant southern EU countries like Spain and Italy are keen to launch the new tool as soon as possible to help economies that have been mauled by the pandemic. But they face a more reluctant north, as well as complex EU decision procedures.

With no central gateway to ensure interoperability yet in place, countries including Estonia, Lithuania, Greece, Spain, Germany and France, are introducing their own solutions to record vaccinations.

DRY RUN

Commission officials told a separate briefing that the gateway – which would allow officials in one EU country to check the health pass of a visitor from elsewhere in the bloc – would enter testing next month.

Twenty member states will be ready to join the trial phase with a view to making it possible to go fully live by mid-June.

The technology for the digital passes is secure and no sensitive personal data would be shared, the officials said.

Disputes between EU countries over supplies of medical equipment, drugs and vaccines have already complicated the bloc’s joint response earlier in the pandemic.

As it now faces a third wave of infections, sceptics say discussions about restarting free travel are premature given low vaccination levels.

The rushed implementation of the joint system raises questions over how visitors from overseas will be handled.

Questions also remain over which vaccines they would honour, with a distinction between those approved for the EU by the European Medicines Agency and those like the Russian or Chinese jabs that might only be allowed by some countries.

Another issue is whether antibody tests provide adequate proof that a person who has recovered from COVID-19 is immune. EU countries including Belgium also worry about discriminating against those who would not get the jab.

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Vaccine OK’d for Older Teens Is Hardest to Manage in Rural US

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

As states expand covid-19 vaccine eligibility to allow shots for 16- and 17-year-olds, teens in rural America may have trouble getting them.

Of the three vaccines authorized in the U.S., currently only one can go to that age group: the Pfizer-BioNTech shot. That vaccine comes in 1,170-dose packages at minimum and expires after five days in a fridge, meaning too many doses on too tight a deadline for many rural communities to manage.

“We’re still trying to get people to accept the vaccine,” said Aurelia Jones-Taylor, CEO of Aaron E. Henry Community Health Services Center, which serves remote regions of the Mississippi Delta. “If we have to race to give out 1,100 doses in five days, that’s untenable.”

Some health experts say vaccinating children — more than a fifth of the nation’s population — is key to ending the pandemic. In the meantime, pressure is mounting to get vaccines out as health officials flag more surges of cases, this time with more contagious variants that seem to affect kids more than the initial virus strain that coursed through the U.S.

“The infection can continue to spread until we get everyone in the population vaccinated, and that includes younger individuals,” said Gypsyamber D’Souza, an epidemiologist with Johns Hopkins Bloomberg School of Public Health.

The logistical challenges of eventually getting the shots to rural kids of all ages will likely continue, at least in the short term. That’s because the companies behind the sole vaccine with approval for 16- and 17-year-olds, Pfizer and BioNTech, have also been the first to seek federal approval to vaccinate younger ages after a trial showed the vaccine was effective in kids 12 through 15 years old. Pfizer spokesperson Steve Danehy said the company hopes to win regulatory approval for that age group before the start of the next school year.

For some families, the shots are so coveted that they’ll travel whatever distance it takes. Dr. Jeannette Wagner Waldron, 45, of Park County, Montana, said the closest place she was able to find a vaccine for her 17-year-old daughter, Julie Waldron, was Billings, which meant a nearly four-hour round trip to a CVS pharmacy there for the teen’s first shot.

“I’m more than willing to drive two hours to get my kiddos vaccinated,” Wagner Waldron said. “They’ve given up a lot, from their activities and seeing their friends, in order to protect people from the virus.”

Not everyone can travel that far for vaccines once, let alone twice to get both doses. Compound that with some reluctance in rural communities to get vaccinated at all. A recent KFF survey showed a larger share of rural residents — 21% — said they wouldn’t get a covid vaccine compared with urban and suburban respondents. That could mean not enough remaining demand for vaccines to use up a 1,170-dose Pfizer package in rural communities. Even if the demand exists, rural health departments may not have enough workers to administer the doses fast enough.

Karen Sullivan, health officer for the Butte-Silver Bow Health Department, said Butte will serve as the main vaccine base for 16- and 17-year-olds across five counties in southwestern Montana that together cover as much area as all of Maryland. She said she’s worried that delivering Pfizer shots to each community could risk wasting doses, but her department may make a new plan if too many people can’t get to Butte.

Health officials there have been trying to convince teenagers and their guardians the shots are safe and worth traveling for since Montana opened covid vaccines to everyone 16 and older April 1. Butte-Silver Bow’s new vaccine campaign includes sharing photos of the area’s school mascots getting the jab and raffle prizes for those who get vaccines.

“What we’re trying to do is get ahead of the variants,” Sullivan said. “We can’t get our 16- and 17-year-olds vaccinated fast enough, in my mind.”

Finding Pfizer vaccines can be challenging even in cities, which serve as medical hubs for rural communities. To help with that, some providers have set up online covid vaccine registration systems specifically for 16- and 17-year-olds, such as one through Stanford Children’s Health for clinics around San Jose, California.

In Mississippi, Jones-Taylor said her center hopes to reach kids through school-based and mobile outreach clinics. But she said that depends on either the Moderna or Johnson & Johnson vaccine, each of which have minimum shipments of 100 doses, gaining regulatory approval for minors. Both manufacturers are testing how their shots work in children.

The Children’s Health Fund, a national nonprofit, has advocated for the “continued urgent inclusion of children of all ages in vaccine trials” and for prioritizing a single-dose, easy-to-store vaccine.

Dr. Cody Meissner, a pediatrician on the vaccine advisory committee for the Food and Drug Administration, questions the rush to extend the vaccines to younger ages without more time to study potential impacts, adding that children so far have been less likely to transmit the virus or die from an infection.

The debate over whether to vaccinate younger kids as a means to end the pandemic may soon be moot, though, said Dr. Monica Gandhi, chief of the Division of HIV, Infectious Diseases and Global Medicine at the University of California-San Francisco. She pointed to a recent study out of Israel — a nation ahead of the rest of the world in its vaccine effort — which showed that infection rates declined even without immunizing children younger than 16. That study has yet to be peer-reviewed.

“We may get to herd immunity without vaccinating all kids,” Gandhi said. “But as long as it’s a safe vaccine, the more people that get it, the more people that develop immunity, the better.”

Back in Park County, which has a population of fewer than 17,000, health officials have seen an increase in covid cases among younger people in recent weeks, some tied to middle and high school sports.

Dr. Laurel Desnick, county health officer, said the county set up vaccine clinics in high schools by working with the state and neighboring counties to split up a shipment of Pfizer vaccines, though that took time to organize. Until mid-April, the county directed 16- and 17-year-olds like Julie Waldron to a county more than 100 miles away for a shot.

“Some of our kids could do it, but not all,” Desnick said. “The further you are from a big center, the harder this gets. We’re rural, but we’re also not as remote as many of the central or eastern Montana counties, and I feel for them.”

For Ava Braham, who turned 16 two days before Montana expanded eligibility to her age, a vaccine clinic in her Park County school means she missed only 20 minutes of class to get her shot this month instead of having to drive more than 50 miles round trip over a mountain pass.

“The biggest thing for me with the vaccine is being able to see my family more often. Both of my grandparents have already gotten the shot, but I will feel more comfortable visiting them,” Braham said. “It’s sort of a moral obligation to help the whole country and the world to just get the shot.”

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FDA, CDC Lift Suspension of Johnson & Johnson Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The US Food and Drug Administration (FDA) will add a warning to the Johnson and Johnson one-dose COVID vaccine and lift its recommended pause on the shots.

The agency acted quickly to get the vaccine back into distribution after a Centers for Disease Control and Prevention (CDC) advisory panel met on Friday and voted to continue to recommend its use in adults ages 18 and up.

The vote came after the CDC and the FDA conducted a safety review of 15 cases of thrombosis-thrombocytopenia Syndrome (TTS) that occurred in women ages 18 to 59 within a few weeks of getting their vaccines. Three of the women died. Seven have been treated in intensive care units.

“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50, at .9 cases per million,” said CDC Director Rochelle Walensky, MD, in a press briefing Friday night.

In the end, the potential benefits of the vaccine far outweighed its risks.

“In terms of benefits, we found that for every 1 million doses of this vaccine, the [Johnson and Johnson] vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Walensky said.

The potential benefits to women over 50 were even greater: It could prevent 4700 hospitalizations and 650 deaths.

“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Walensky said.

She pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised with TTS. 

As a result, regulators felt like their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.

Walensky said the Johnson and Johnson vaccine remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.

Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk for the rare clotting disorder to its fact sheets for patients and doctors.

Janet Woodcock, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as Saturday morning.

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Spain to Test Mixing COVID Vaccines After Restricting AZ Shot

MADRID (Reuters) – Spain will study the effects of mixing different coronavirus vaccines, government researchers said on Monday, responding to shifting guidelines on the safety of the AstraZeneca’s shot.

Along with several other European countries, Spain restricted vaccines produced by the Anglo-Swedish drug maker to people over 60 after regulators linked it to a rare form of brain blood clots, mostly in younger women.

“After decisions by various European public health authorities to suspend use of the AstraZeneca vaccine in under 60 year olds, we are setting out to urgently find scientific evidence to support decision making around possible alternatives,” Raquel Yotti, director of the Carlos III Health Institute, told a news conference.

The trial will draw on a sample of 600 people of all ages from across Spain, said Jesus Frias Iniesta, clinical research coordinator at Carlos III.

“The study’s objective is…to determine within 28 days whether a second dose of the Pfizer vaccine can be given to patients who have received the AstraZeneca vaccine,” he said.

A UK study on mixing vaccines was expanded last week to include shots made by Moderna and Novavax, while France and Germany are considering giving an alternative to under 60s who received a first dose of AstraZeneca.

Separately, Spain’s El Mundo newspaper reported the health ministry was considering delaying second doses for under 80 year olds to maximise the number of people who received at least one injection.

Patients would receive a second shot of vaccines produced by Pfizer and Moderna eight weeks after the first, El Mundo said. The European Medicines agency recommends a 28-day gap between Moderna shots and 21 days between Pfizer.

The proposal would signal a sharp departure from the current national strategy, which favours giving vulnerable age groups a full course of two shots as quickly as possible.

The Health Ministry was not immediately available for comment.

Several real-world studies have shown a first dose of the Pfizer-BioNTech vaccine provides a high level of protection.

Despite delays to the deployment of the one-shot Johnson & Johnson vaccine and supply disruptions at AstraZeneca, Spain still expects to have half its 47-million population fully inoculated by late July.

Data released on Friday showed 7% of the population had received a full course, while 19% had received at least one dose.

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COVID Vaccine Makers Have More Than Boosters in the Works

 

Vaccine boosters are part of the plan to protect against COVID-19 and emerging variants, but so are entirely new approaches to vaccination, including delivery routes that eliminate the need for injections, and easier storage to help ease vaccine supply shortages.

Next-generation COVID vaccines will have many different targets. Read what developers are investigating next.

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J&J Pause Magnifies Worry About COVID-19 Vaccine Hesitancy

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center.

The news today that states are being asked to pause administration of the Johnson & Johnson COVID-19 vaccine is bringing new fears of vaccine hesitancy that could push back the nation’s goal for herd immunity.

The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are reviewing data involving six reported US cases of a rare and severe kind of blood clot — cerebral venous sinus thrombosis — in people who got the J&J vaccine. All six cases were in women 18 to 48 years old, and symptoms occurred 6 to 13 days after their vaccination.

More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States.

William Schaffner, MD, an infectious disease expert at Vanderbilt University School of Medicine in Nashville, Tennessee, told Medscape Medical News that several messages are important to emphasize given the potential for more hesitancy.

“One is that our safety surveillance system is very comprehensive,” he said. “It is very sensitive and it works, and we’re being transparent about it.”

Another is that the number of cases being reviewed is literally 1 in a million.

“We’re talking about needles in haystacks here,” Schaffner said. “These blood-clotting events are an even smaller risk than the blood-clotting events associated with birth control pills.”

He said he has heard questions about why the potential complications weren’t  caught earlier and criticism that the complications are proof the trial was rushed.

“That’s not the case,” Schaffner explained. “When you have a trial of only 15,000 people — though that’s a huge trial — if you have a risk that is 1 in a million, it’s very unlikely to show up in the trial. You have to monitor what happens when you start using drugs or vaccines in the real world and you give it to literally millions of people.”

The CDC will convene its Advisory Committee on Immunization Practices (ACIP) on Wednesday to review the cases, and the FDA will also review them.

Schaffner said he hopes and expects after a review that Johnson & Johnson vaccine administration can resume, perhaps with restrictions, as some European countries have placed on the AstraZeneca vaccine.

Johnson & Johnson vaccine is one of three vaccines approved for emergency use in the United States. The vaccines from Moderna and Pfizer-BioNTech use messenger RNA instead of adenovirus and no serious side effects have been reported in the tens of millions in the US who have received those shots.

Johnson said in a statement, “The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their healthcare provider.”

Tim Schacker, MD, vice dean for research and an infectious disease physician with the University of Minnesota Medical School in Minneapolis, told Medscape Medical News that the Johnson & Johnson news today is another barrier to achieving herd immunity, a goal for which “we already had a long way to go.”

A national survey finds that to be the case as well.

Last week, Surgo Ventures released the results of its second survey on enthusiasm for receiving a COVID-19 vaccine and found that acceptance is generally high, with 59% of the population now saying they have already been vaccinated or want to be as soon as they can get one.

That was up from 40% in Surgo’s first survey, conducted in early January.

However, the survey authors said in a press release that respondents’ answers to when they would get a shot — “as soon as it’s available,” “in three months,” “in a year,” etc. — combined with current vaccination rates suggest that doses could start to outpace demand by the end of this month, which is earlier than expected. And that’s long before the nation reaches the 70%-90% threshold needed for herd immunity.

Benefit Outweighs Risk

Schacker applauded the decision to halt administration of the J&J vaccine.

“I think the FDA and the CDC did exactly the right thing by pausing for a day or two to look at the data and make an assessment,” he said.

He said it’s also important to remember that all medications come with risks.

“With people on Lipitor (atorvastatin), the risk of muscle necrosis, known as rhabdomyolysis — which people can die from — is 1 in 100,000, 10 times greater than the blood clot risk talked about with J&J. I don’t mean to trivialize it,” Schacker said. “I’m just saying we’re all on medications that have risks.”

He said he also hopes the reviews in the next couple of days will clear the Johnson & Johnson vaccine for use because it has advantages over the others: it doesn’t have the same requirements for refrigeration; it’s one dose;  and it’s a key to vaccinating those in hard-to-reach populations.

“The benefits of any of the COVID vaccines, I think, outweigh the risks,” he said.

Schaffner and Schacker declared no relevant financial relationships.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

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EU Seeks New Contract With Pfizer/BioNTech for Up to 1.8 Bln Vaccines From 2022: EU Source

BRUSSELS (Reuters) – The European Commission is seeking EU governments’ approval to launch talks with Pfizer and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters.

Earlier on Friday, German daily Die Welt reported that the Commission was shortly to sign contracts to buy up to 1.8 billion doses, but did not say with which company.

The EU official, who asked not to be named because the matter is confidential, said the EU executive had already decided to approach Pfizer-BioNTech and that EU governments backed the plan, though there was not yet a definitive approval.

A Commission spokesman confirmed plans to buy the additional doses, of which half would be optional.

He also confirmed that the EU executive had already identified one supplier, a manufacturer of mRNA vaccines, but declined to comment on which company would be approached to negotiate the contract.

“If provided the opportunity Pfizer and BioNTech are prepared to supply Europe with hundreds of millions of doses of COVID vaccines in 2022 and 2023 produced in our manufacturing facilities in Europe,” a Pfizer spokesman said.

The two companies have the capacity to produce more than 3 billion doses of vaccine in 2022, he added.

Pfizer-BioNTech and Moderna are already supplying the EU with mRNA vaccines and German biotech firm CureVac is seeking EU approval for its mRNA shot.

The vaccines would be delivered under monthly timetables and with clauses obliging the supplier to deliver, the EU official said.

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