By Amber Dance

Children of color vulnerable to disease, loss of caretakers

The pandemic’s racial disparities know no age limit, and children of color have been more deeply affected than their white peers, reports Edwin Rios at Mother Jones. Rios leads with a recent study from the journal Pediatrics, which found nearly two-thirds of the more than 140,000 U.S. children who lost a caregiver during the pandemic were from racial or ethnic minorities. American Indian and Alaska Native children were particularly affected, as were Black and Hispanic children. “For every four COVID-19 deaths, one child was left behind without a mother, father and/or a grandparent,” study author and CDC epidemiologist Susan Hillis told NPR. The study covered deaths through the end of June 2021; she now estimates around 175,000 kids have lost a caregiver.

This is just one of the ways the pandemic has disproportionately impacted children of color, writes Rios: “This racist reality isn’t limited to adults.” Black and Latino children are more likely to contract COVID, to have health conditions that raise risk for severe disease, to require hospitalization, and to develop the chronic, post-COVID inflammatory condition called MIS-C. Black children are more likely to die of the disease than white kids. The same pattern holds true for the flu, reports Catherine Roberts at The Washington Post, with the greatest racial disparities seen in children younger than 5. That’s partly due to lower rates of flu vaccination among children of color, a disparity unlikely to change with COVID vaccines. Though COVID-19 vaccines may be authorized for children as young as 5 in a matter of weeks, access will probably be a challenge for many children of color, writes Nada Hassanein in USA Today. “It’s not a surprise this is happening,” said Dr. Georges Benjamin, executive director at the American Public Health Association. “We obviously had disparities with their parents, so why shouldn’t we have disparities with their kids?”

FDA committee supports boosters on slim data

On Thursday, the FDA’s advisory committee recommended authorization of Moderna’s half-dose booster for people over 65, and those over 18 and at higher risk due to health conditions or riskier jobs. That would match the eligibility guidelines for Pfizer boosters. The committee also recommended boosters for all adults who initially received the Johnson & Johnson vaccine.

Both votes were unanimous, but the committee struggled with limited information. For example, Moderna’s booster data was based on 149 people.

“The data are not perfect, but these are extraordinary times and we have to work with imperfect data,” said FDA committee member Dr. Eric Rubin of the Harvard School of Public Health.

A study released last Friday suggests that all three authorized vaccines—Moderna’s, Johnson & Johnson’s, and Pfizer’s — produce robust, cell-based immunity for at least eight months without a booster, reports Sony Salzman at ABC News. Johnson & Johnson’s single-dose shot led to lower levels of long-lasting antibodies, while the miRNA vaccines led to a high peak of efficacy before a drop-off. Waning antibodies could allow breakthrough infections, but the body’s T cells would then keep that infection mild, Salzman explains.

Moderna’s data showed that as time elapsed after recipients’ first two shots, antibody levels dropped and breakthrough infections did occur. But compared to Pfizer’s shot, Moderna has held up significantly better against severe disease and hospitalization, so the company concentrated its presentation on prevention of mild and moderate disease. A Moderna booster shot did amp up antibody levels fourfold in 87.9% of subjects — narrowly missing the FDA’s target threshold of 88.4%, reports Sharon LaFraniere at The New York Times. Moderna says the half-size dose should minimize side effects such as fever and aches.

Johnson & Johnson’s U.S.-based study found that a two-shot regimen raised the efficacy of the vaccine to more than 90%. However, that trial took place pre-delta, calling into question its relevance now, and studies in other locales did not show such a change. In this case, the committee recommended a second dose two or more months after the first, for anyone over 18 who received that vaccine.

Many of the FDA advisors suggested this dose should more properly be thought of as the second in a two-shot series, rather than a ‘booster.’ “I think, frankly, this was always a two-dose vaccine,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia. The company has not applied for two-dose (non-booster) authorization, because its one-and-done appeal remains high in many parts of the world, writes Helen Branswell at STAT.

Neither decision is final — the CDC’s advisory committee will weigh in next this Thursday. (Watch the livestream here).

Booster shots have already proven popular. Since Aug. 13, more than 9 million people have received a third dose — either because they are immunocompromised or because they were deemed eligible for a third Pfizer shot by the CDC on Sept. 24 (or just because they wanted one). During October, more people are getting an additional dose than either first or second shots.

Some answers on mixing and matching vaccines

At its Friday meeting, the FDA’s vaccine committee discussed but did not vote on data from a new study that gave people boosters that didn’t necessarily match their initial vaccine brands. The preprint report, from scientists at the National Institute of Allergy and Infectious Diseases and collaborators, has not yet been reviewed by other scientists.

The research involved nine groups of people (about 50 per group) who got an initial series of one of the three authorized vaccines, and were then randomly assigned to one of the three vaccines for a booster (epidemiologist Katelyn Jetelina has a handy diagram on her blog). Mixing brands appears to be safe, though it didn’t allow participants to dodge flu-like side effects. And the winning combination among study participants — at least as imperfectly measured by antibody levels — was J&J first, then Moderna as a boost. A Pfizer booster was also effective for people who initially received Johnson & Johnson. For those who received Pfizer first, a Pfizer booster was good but Moderna was even better; either mRNA vaccine was fine as a booster for people who started with a Moderna course.

The FDA has not had time to analyze the study in detail, so no decision could be made yet. At the meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested emergency authorization of boosters that differ from initial vaccines is possible. Other experts have voiced similar thoughts, reports The New York Times: Immunologist Scott Hensley of the University of Pennsylvania said, “Folks having the Johnson & Johnson should probably get an mRNA booster.”

CDC urges pregnant people to get vaccinated

Low vaccination rates among pregnant people, combined with high risk for severe illness, recently prompted the CDC to release a health advisory promoting vaccination among those who are pregnant, recently were pregnant, or may soon become pregnant. The agency cited COVID-19 risks not only to the health of the pregnant person but also to the baby, such as preterm birth and stillbirth. More than 22,000 pregnant people have been hospitalized, and at least 180 have died since the pandemic began. “I really can’t blame these women for being confused and not feeling comfortable taking the vaccine,” Dr. Nida Qadir of the Ronald Reagan UCLA Medical Center told Brittany Shammas at The Washington Post. The CDC did not formally recommend the vaccine for pregnant people until August, and vaccine trials with pregnant subjects are only underway now.

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WASHINGTON (AP) — The Food and Drug Administration is wrestling with whether and when to offer another dose of the single-shot Johnson & Johnson COVID-19 vaccine, while a new study out Wednesday raises the prospect that using a different brand as the booster might work better.

In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for J&J boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant of the coronavirus.

The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will recommend whether to back booster doses of both the J&J and Moderna vaccines. That’s one step in the government’s vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who actually should get them.

Adding to the complexity is whether it’s OK to use a booster that’s a different brand than someone’s initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine “still affords protection against severe COVID-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.

J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots while less than 15 million Americans got the J&J shot.

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WASHINGTON (AP) — U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem.

The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk” for those getting the shot.

The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of them required hospitalization and one person died, the FDA said.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.

The number of cases reported in connection with J&J’s vaccine represents a tiny fraction of the nearly 13 million Americans who have received the one-dose shot. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination.

J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world.

The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.

The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered.

The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.

Vaccines historically provide broad protection with little risk but come with occasional side effects just like other drugs and medical therapies. The three COVID-19 vaccines used in the U.S. were each tested in tens of thousands of people, but even such huge studies can’t rule out extremely rare side effects.

The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers and patients to a federal vaccine safety database.

Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines.

J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. But early on, it was linked to another rare risk, of blood clots, and the company hasn’t been able to produce as much as expected because of problems at a Baltimore factory that helps make the shots.

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The move follows recommendations by state and federal officials who had temporarily stopped use of the J&J vaccine after rare severe reactions were reported.

The vaccine will be available starting Thursday at the clinic at Alessandro High School in Hemet. Its use will expand to other fixed locations and mobile vaccine teams next week.

“Bringing back the Johnson and Johnson vaccine will provide us with another tool to help vaccinate as many Riverside County residents as possible,” said Dr. Geoffrey Leung, public health officer for Riverside County. “We are confident the vaccine is safe and effective.”

Board of Supervisors Chair Karen Spiegel, who received the J&J vaccine, noted the importance of the single dose vaccine to protect more Riverside County residents from COVID-19.

“The single dose of the Johnson and Johnson vaccine makes it more convenient for residents and helps our county teams vaccinate more people faster without the need for a second dose weeks later,” said Chair Spiegel, Second District Supervisor. “Safety is a priority in all vaccine.”

Riverside County has approximately 17,000 doses of the J&J vaccine on hand and it has been administered more than 17,000 times in the county without a severe reaction. Overall, more than 1.5 million doses have been administered of the J&J, Moderna and Pfizer vaccines in Riverside County among the county run clinics, and those operated by community partners and other providers.

To make an appointment, click www.rivcoph.org/covid-19-vaccine or call 2-1-1 for those needing assistance.

Rivco.org • Contributed

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One of the largest reports on COVID-19 vaccination in pregnancy bolsters evidence that it is safe although the authors say more comprehensive research is needed.

The preliminary results are based on reports from over 35,000 U.S. women who received either the Moderna or Pfizer shots while pregnant. Their rates of miscarriage, premature births and other complications were comparable to those observed in published reports on pregnant women before the pandemic.

The new evidence from researchers at the federal Centers for Disease Control and Prevention was published Wednesday in the New England Journal of Medicine.

None of the women involved received Johnson & Johnson’s one-shot vaccine, which became available after the study, and is now in limbo as U.S. authorities examine reports of blood clots in a handful of women.

Separately, the American Society for Reproductive Medicine on Tuesday endorsed vaccination in pregnancy, based on evidence it has been evaluating for over a year.

‘’Everyone, including pregnant women and those seeking to become pregnant, should get a COVID-19 vaccine. The vaccines are safe and effective,’’ the society said in a statement.

A society representative said the group has not evaluated the latest evidence on Johnson & Johnson’s vaccine.

An American College of Obstetricians and Gynecologists representative said the CDC report is promising but that longer-term follow-up is needed. That group has said previously that COVID-19 vaccination should be available to pregnant women and to those who are breastfeeding, and many pregnant U.S. women have chosen to be vaccinated.

Although pregnant women were excluded from studies that led to emergency authorization for the vaccines, evidence showed no harms in women who were unknowingly pregnant when they enrolled.

Dr. Laura Riley, ob-gyn chair at New York’s Weill Cornell Medicine, said the new results are reassuring.

‘’It is great to have data to share with our patients who continue to weigh the risks and benefits of vaccination,” she said. “They know the potential complications of COVID infection in pregnancy and now there is some safety data in human pregnancies.’’

Pregnant women who become infected with the coronavirus face elevated risks for complications including intensive-care hospitalization, premature births and death.

The study authors, led by the CDC’s Dr. Tom Shimabukuro, said continued monitoring and more evidence is needed including on women who get COVID-19 vaccinations in the early stages of pregnancy.

Their study included information on 35,691 pregnant U.S. women who participated in a voluntary smartphone-based vaccination surveillance system and who received Moderna or Pfizer vaccines between mid-December 2020 and late February.

It also included reports on pregnancy complications from almost 4,000 women enrolled in a U.S. vaccine safety registry. Of these, 86% or 712 resulted in a live birth, mostly among women vaccinated in the third trimester.

Most women in the surveillance group reported injection site pain but more serious reactions were less common. Pregnant women seemed more prone to injection site pain with both vaccines but less likely to experience other reactions than non-pregnant women.

In the vaccine registry, about 13% of pregnant women reported miscarriages, less than 1% stillbirths, 9% premature births and 2% birth defects. Those rates are all within the same range observed in reports in pregnant women before the pandemic.

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The Baltimore factory hired to help make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material going into a batch of shots, U.S. regulators said Wednesday.

The Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled Emergent BioSciences factory.

Agency inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.

Other problems cited in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredients.

Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.

Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.

After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. AstraZeneca has yet to seek emergency authorization for use of its vaccine in the U.S.

The Baltimore factory halted all production late last week at the FDA’s request. The agency hasn’t given emergency approval to the factory, which is needed before any vaccine material made there can be distributed.

All the bulk vaccine substance inside Emergent’s factory, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said.

“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the FDA said.

At the moment, use of the J&J vaccine is on hold in the U.S. as government health officials investigate its possible connection to very rare blood clots. Their decision on whether to allow its use to resume could come Friday.

On Tuesday, the European Medicines Agency’s safety committee concluded the blood clots are a very rare side effect but that the vaccine’s benefits outweigh that risk.

Emergent, a little-known drug manufacturing contractor, was granted a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.

After the J&J vaccine batch was contaminated, FDA inspectors started checking the Emergent factory on April 12 and finished their investigation on Tuesday.

The inspectors also reviewed security camera footage, which showed employees carrying unsealed bags of medical waste around in the factory, with the bags touching materials ready to be used to make vaccine batches.

The footage also showed employees moving between manufacturing areas for the two vaccines without documenting whether they changed protective gowns and showered in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothing on the floor and then tossing it in open trash cans.

The report noted that Emergent didn’t sufficiently investigate the contamination of the later-discarded J&J batch and didn’t appear to have done any extra cleaning after it was discovered.

“There is no assurance that other batches have not been subject to cross-contamination,” the report stated.

It noted other problems at the factory, known as Bayview: inadequate procedures for assuring the vaccine met all quality and purity requirements, and floors and walls too damaged to be properly sanitized. The plant also was too small and not properly designed for thorough cleaning, maintenance and operations, inspectors said.

It’s unclear how long it will take the companies to resolve all the problems.

J&J has pledged to provide 100 million doses for the U.S. by the end of May and 1 billion doses globally by the end of the year.

“Right now, we can’t speculate on any potential impact this could have on the timing of our vaccine deliveries,” J&J said in a statement.

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Health officials say to be vigilant, but to remember that reports of blood clots that may be associated with J&J’s single-dose vaccine are exceedingly rare.

“It’s less than one in a million,” said Dr. Anthony Fauci, the top U.S. infectious disease specialist.

Common side effects after getting a COVID-19 vaccine can include arm pain and normal flu-like symptoms for a couple days afterward. Those aren’t pleasant, but they aren’t what officials are concerned about.

Instead, be on the lookout for different, more severe symptoms associated with the clots, particularly between one and three weeks after the shot. Those include severe headache, backache, abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin or bruising.

If those symptoms show up, seek medical treatment right away. The Centers for Disease Control and Prevention has issued advice to help doctors spot these rare clots and safely treat them.

AP Briefs

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State officials directed counties and other providers on Tuesday to halt use of the vaccine per federal recommendation. But Gov. Gavin Newsom said he does not expect the halt to “materially impact our ability to fulfill our expectations.” Vaccinations are expected to be available for people 16 and older Thursday and California plans to lift most pandemic restrictions in mid-June.

Newsom said the Johnson & Johnson vaccine accounts for only 4% of the state’s current supply and that inoculations of more than 3 million people a week will keep the state on track to reopen broadly June 15. He said officials are working to switch about 8,800 people who had made Johnson & Johnson reservations via a state online platform to Pfizer and Moderna shots.

“The J&J vaccine has been extraordinarily safe,” he said at an event in Butte County.

More than 15 million Californians are fully or partially vaccinated. Of those, nearly 900,000 have received J&J shots, according to the state’s public health agency, including Newsom and other top health officials who publicly received the shots to demonstrate the vaccine’s safety.

Centers for Disease Control and Prevention and Food and Drug Administration officials said Tuesday that they were investigating blood clots in six women that emerged in the days after they were vaccinated, in combination with reduced platelet counts. The federal officials recommended pausing use of the vaccine until they know more.

More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with no or mild side effects.

Dr. Kirsten Bibbins-Domingo, chair of the department of epidemiology and biostatistics at the University of California-San Francisco, said there is great enthusiasm for the J&J vaccine in vulnerable communities because it requires only one shot and has high brand name recognition.

It has also made it easier to vaccinate mobile communities, such as homeless people who may be harder to locate for a second shot, people who have to drive long distances to get the shot or other hard-to-reach populations, she said.

“We worry that it puts a big damper on efforts that have really been ramping up,” Bibbins-Domingo said of the pause.

The decision to pause J&J inoculations show the agencies are working hard to reassure the public, but anything that raises concerns about vaccine safety could increase vaccine skepticism, said Dr. Timothy Brewer, a professor of epidemiology at the UCLA Fielding School of Public Health and Medicine.

“Our case rates are still pretty low, our hospitalization rates and mortality rates are very low relative to what they were in January,” Brewer said. “So I think we’re still moving forward.”

Counties and health care providers reported little disruption to vaccination appointments, in part because of vastly reduced J&J shipments this week due to production problems. California received 67,000 doses of J&J this week compared with 575,000 last week.

Several counties are already vaccinating people 16 and older in advance of the state expanding eligibility on Thursday.

Isis Gardner, an 18-year-old senior at San Pedro High School in Los Angeles, received her first shot of the Pfizer vaccine Tuesday rather than the Johnson & Johnson vaccination she was scheduled to get.

“My mom, she’d been telling me the Pfizer is better than the J&J” because of possible blood clots, said Gardner, adding that she’s “definitely happy” about the substitution.

Riverside County canceled mobile clinic appointments Tuesday for roughly 400 people. A clinic scheduled for Saturday in the mountain community of Idyllwild will use Pfizer instead of the J&J vaccine and vaccinators will return in May to deliver second shots, said Jose Arballo, a spokesman for Riverside County’s health agency.

In Los Angeles, city officials said they would use other vaccine in place of 3,000 scheduled J&J vaccinations.

Los Angeles County public health officials said people who received the vaccine in the last three weeks should contact their doctor if they experience symptoms of “these unusual clots,” including severe headaches, abdominal or leg pain, and shortness of breath.

State epidemiologist Dr. Erica Pan said California will convene a regional scientific safety workgroup to review information provided by the federal government. The review group created by California and joined by Nevada, Washington and Oregon approved Johnson & Johnson for use on March 3. California got its first shipment of the shots that week.

Newsom, a Democrat, created the group amid fears that former President Donald Trump’s administration would politicize the approval process. The group reviewed the FDA’s approval of the shot and deemed it safe and effective.

___

Taxin reported from Orange County. AP journalists Janie Har in San Francisco and Marcio J. Sanchez in Los Angeles contributed to this report.

KATHLEEN RONAYNE and AMY TAXIN Associated Press

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SACRAMENTO, Calif. (AP) — California’s pause on using the Johnson & Johnson vaccine as federal agencies examine a possible and rare side effect is unlikely to affect vaccination efforts in the nation’s most populous state as it moves to start inoculating people 16 and older this week.

State officials directed counties and other providers on Tuesday to halt use of the vaccine per federal recommendation. But Gov. Gavin Newsom said he does not expect the halt to “materially impact our ability to fulfill our expectations.” Vaccinations are expected to be available for people 16 and older Thursday and California plans to lift most pandemic restrictions in mid-June.

Newsom said the Johnson & Johnson vaccine accounts for only 4% of the state’s current supply and that inoculations of more than 3 million people a week will keep the state on track to reopen broadly June 15. He said officials are working to switch about 8,800 people who had made Johnson & Johnson reservations via a state online platform to Pfizer and Moderna shots.

“The J&J vaccine has been extraordinarily safe,” he said at an event in Butte County.

More than 15 million Californians are fully or partially vaccinated. Of those, nearly 900,000 have received J&J shots, according to the state’s public health agency, including Newsom and other top health officials who publicly received the shots to demonstrate the vaccine’s safety.

Centers for Disease Control and Prevention and Food and Drug Administration officials said Tuesday that they were investigating blood clots in six women that emerged in the days after they were vaccinated, in combination with reduced platelet counts. The federal officials recommended pausing use of the vaccine until they know more.

More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with no or mild side effects.

Dr. Kirsten Bibbins-Domingo, chair of the department of epidemiology and biostatistics at the University of California-San Francisco, said there is great enthusiasm for the J&J vaccine in vulnerable communities because it requires only one shot and has high brand name recognition.

It has also made it easier to vaccinate mobile communities, such as homeless people who may be harder to locate for a second shot, people who have to drive long distances to get the shot or other hard-to-reach populations, she said.

“We worry that it puts a big damper on efforts that have really been ramping up,” Bibbins-Domingo said of the pause.

The decision to pause J&J inoculations show the agencies are working hard to reassure the public, but anything that raises concerns about vaccine safety could increase vaccine skepticism, said Dr. Timothy Brewer, a professor of epidemiology at the UCLA Fielding School of Public Health and Medicine.

“Our case rates are still pretty low, our hospitalization rates and mortality rates are very low relative to what they were in January,” Brewer said. “So I think we’re still moving forward.”

Counties and health care providers reported little disruption to vaccination appointments, in part because of vastly reduced J&J shipments this week due to production problems. California received 67,000 doses of J&J this week compared with 575,000 last week.

Several counties are already vaccinating people 16 and older in advance of the state expanding eligibility on Thursday.

Isis Gardner, an 18-year-old senior at San Pedro High School in Los Angeles, received her first shot of the Pfizer vaccine Tuesday rather than the Johnson & Johnson vaccination she was scheduled to get.

“My mom, she’d been telling me the Pfizer is better than the J&J” because of possible blood clots, said Gardner, adding that she’s “definitely happy” about the substitution.

Riverside County canceled mobile clinic appointments Tuesday for roughly 400 people. A clinic scheduled for Saturday in the mountain community of Idyllwild will use Pfizer instead of the J&J vaccine and vaccinators will return in May to deliver second shots, said Jose Arballo, a spokesman for Riverside County’s health agency.

In Los Angeles, city officials said they would use other vaccine in place of 3,000 scheduled J&J vaccinations.

Los Angeles County public health officials said people who received the vaccine in the last three weeks should contact their doctor if they experience symptoms of “these unusual clots,” including severe headaches, abdominal or leg pain, and shortness of breath.

State epidemiologist Dr. Erica Pan said California will convene a regional scientific safety workgroup to review information provided by the federal government. The review group created by California and joined by Nevada, Washington and Oregon approved Johnson & Johnson for use on March 3. California got its first shipment of the shots that week.

Newsom, a Democrat, created the group amid fears that former President Donald Trump’s administration would politicize the approval process. The group reviewed the FDA’s approval of the shot and deemed it safe and effective.

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