Johnson & Johnson had a very bad week – but fears of negative reactions and blood clots are likely overblown

johnson & johnson vaccine
Nurse Elizabeth Johnson administers a COVID-19 vaccine to Melissa Mendez in Reading, Pennsylvania.

Johnson & Johnson’s coronavirus vaccine rollout hit several unfortunate snags this week – some far worse than others.

The New York Times reported on Tuesday that 62 million of the company’s vaccine doses must be checked for contamination, following an error at a Maryland manufacturing plant that already ruined 15 million doses. The plant’s workers accidentally mixed up some vaccine ingredients last month.

Then a vaccination site in Colorado, three sites in North Carolina, and one in Georgia all temporarily stopped administering Johnson & Johnson’s shot after about 45 people in total experienced minor adverse reactions involving nausea, dizziness, fainting, or lightheadedness.

To top it off, European regulators announced Friday that they are investigating Johnson & Johnson’s shot for links to unusual blood clotting after four blood-clot cases, including one death, were reported among vaccine recipients.

The timing of these developments was unfortunate, experts said, but there’s no reason to doubt the shot’s safety yet.

“You don’t want to be fueling unnecessary worries about the safety of vaccines when you’re still seeing an enormous outbreak and death rates all over the world from COVID,” Art Caplan, a bioethicist at New York University, told Insider.

He added that the side effects observed at the US vaccination sites were “absolutely trivial.”

Although symptoms like nausea and fainting aren’t common responses to coronavirus vaccines, they aren’t abnormal, either.

“When you see these clusters [of side effects], they usually are worked out and have no relation to the vaccine,” Arnold Monto, an epidemiologist at the University of Michigan’s School of Public Health, told Insider. Monto chairs the Food and Drug Administration’s Vaccine Advisory Committee, which voted to recommend the Pfizer, Moderna, and Johnson & Johnson shots.

People could get dizzy or nauseous for many reasons

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Kristine Ko, right, waits in line for her vaccine at the Cal State LA walk-up mass vaccine site in Los Angeles on April 8.

Most of the negative reactions to Johnson & Johnson’s shot occurred within 15 minutes after a person got vaccinated, public-health officials in Colorado, Georgia, and North Carolina reported. In total between the three states, seven people were taken to hospitals for observation. As of Friday, all but one had been released and everyone was expected to fully recover.

Officials haven’t yet pinpointed why these clusters of adverse reactions were identified in such a short time frame. But they’ve emphasized that there’s no reason to be concerned about the shot itself.

In a news release, Georgia’s public health commissioner, Kathleen Toomey, said the state was looking into “what may have caused the reactions, including the conditions at the fairgrounds such as heat and the ability to keep the site cool.”

Caplan said it’s also possible that the people who felt dizzy or nauseous were elderly or had underlying health conditions that may have predisposed them to adverse reactions. And once one site reports a cluster of patient reactions, that makes others more likely to look for them and take swift action.

Whatever the reason, Monto said, the fact that adverse reactions are being reported and investigated shows that local officials are working hard to minimize harm.

“Any pause in vaccination shows that the system is working because we’re not trying to sweep anything under the rug,” he said.

In a statement, Johnson & Johnson told Insider that it takes all adverse reactions seriously. The company said it would “carefully assess the events” and share any findings with the FDA.

“There is no greater priority than the safety and well-being of the people we serve,” the statement said.

The link between J&J’s shot and blood clots remains tenuous

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A vial of Johnson & Johnson’s shot.

Just four blood-clot cases have been identified among people who’ve gotten Johnson & Johnson’s shot so far. In one of those cases, a participant in the company’s clinical trial died of a clotting disorder.

The other three blood-clot cases occurred during J&J’s US rollout, which has administered nearly 5.4 million doses of its vaccine. That’s fewer than one clot case per 1 million shots.

Experts aren’t convinced there’s a cause-and-effect relationship at all, though.

“It isn’t really clear how many people get blood clots anyway,” Caplan said. ‘That makes it hard to know whether it’s connected to vaccination.”

The European Union’s health regulator, the European Medicines Agency (EMA), announced its investigation after receiving information about the blood-clot cases from the FDA, Bloomberg reported. The EU authorized Johnson & Johnson’s vaccine in March and is scheduled to roll out the shot later this month.

The agency said it wasn’t sure what relationship, if any, existed between the vaccine and blood clots.

Earlier this week, the EMA announced that potentially fatal blood clots might be a rare side effect of AstraZeneca’s vaccine, which has been authorized in more than 110 countries but not yet in the US. Both that shot and Johnson & Johnson’s are viral-vector vaccines, which introduce a coronavirus gene into the body using a genetically engineered common-cold virus. Scientists don’t know whether the platform itself could be linked to clotting.

Still, any risk of clots should be weighed against the risk of getting COVID-19, Caplan said.

“If I live in Brazil and I’m still seeing 3,000 deaths a day, and somebody said to me, ‘We’re going to pull AstraZeneca vaccine out of here because we found somebody who died of a blood clot that might be related to the vaccine,’ I’d say, ‘You better recalculate your risk-benefit ratio,'” he said.

The bigger problem is a lack of supply

For now, the most pressing issue with Johnson & Johnson’s vaccine isn’t any safety concern – it’s the lack of consistent supply.

Johnson & Johnson promised to ship 24 million doses in US this month, but it’s unclear if the company will meet that goal, given the recent manufacturing issues, which occurred at a plant run by Emergent Biosolutions, a US government contractor.

Quality-control managers must first test 62 million doses to see if they can be salvaged, and the FDA must also certify that the Maryland plant can release more doses to the public.

Jeff Zients, the White House COVID-19 response coordinator, said at a Friday briefing that Johnson & Johnson “expects a relatively low level of weekly dose delivery” until the FDA signs off on the plant.

The total number of Johnson & Johnson shots allocated to states and other jurisdictions is expected to drop around 85% next week, to around 1.5 million doses. But that decrease follows an unprecedented surge of roughly 11 million doses last week.

Johnson & Johnson has said it’s still on track to provide close to 100 million doses by the end of May.

Allison DeAngelis contributed reporting.

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European regulators are watching J&J’s vaccine for unusual blood clots

Registered Nurse Robert Orallo administers the Pfizer Covid-19 vaccine at the Blood Bank of Alaska in Anchorage on March 19, 2021.

  • European regulators are investigating whether Johnson & Johnson’s vaccine could cause blood clots.
  • The investigation was opened after four cases were reported, including one fatality.
  • J&J’s vaccine was authorized for European distribution last month, but hasn’t been given out yet.
  • See more stories on Insider’s business page.

European regulators are investigating whether Johnson & Johnson’s COVID-19 vaccine caused unusual blood clotting after four cases were reported in vaccine recipients, including one fatality.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee disclosed Friday that they are reviewing the vaccine after three people who received J&J’s vaccine in the US and another who was involved in a clinical trial developed blood clots. It’s currently not clear if the vaccine caused these clots.

J&J said that it was working closely with experts and regulators to assess data coming in, but that so far, they have found a small number of very rare side effects.

The investigation comes as European states prepare to add the vaccine to their roster of COVID-19 shots. J&J’s vaccine was recommended for authorization by the EMA on March 11, but has not yet been distributed.

Approximately 4.9 million doses of J&J’s vaccine have been administered in the US, according to the CDC.

It’s not the first time the link between vaccines and blood clots has been investigated

The EMA has been closely watching reports of blood clots linked to another vaccine: AstraZeneca’s two-dose immunization.

The agency stated Wednesday that blood clots can be a “very rare” side effect of AstraZeneca’s shot in people with low blood platelet levels. Approximately 169 cases of blood clots in the brain and 53 cases of blood clots in the spleen had been reported as of April 4, according to the EMA.

Cases of blood clots have also reported in patients who had received Moderna and Pfizer’s vaccines, a J&J spokesperson said in a statement.

Issues have been popping up as J&J’s shot has rolled out in the US.

One of the factories that produces both drug companies’ vaccines is in hot water after it was reported by the New York Times that 15 million doses of Johnson & Johnson’s vaccine had been cross-contaminated with AstraZeneca’s vaccine at a U.S. factory run by Emergent BioSolutions. None of those shots were distributed to the public.

Officials in Colorado and North Carolina stopped giving out J&J’s vaccine this week after two dozen people experienced minor adverse reactions like nausea and dizziness.

J&J’s stock traded down about 1% on Friday morning.

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States are only getting 700,000 Johnson & Johnson vaccine doses next week, down from almost 5 million this week

johnson and johnson vaccine
A nurse loads a syringe with a dose of Johnson & Johnson’s COVID-19 vaccine on March 9, 2021 in Athens, Ohio.

  • Just 700,000 doses of the Johnson & Johnson vaccine will be distributed in the US next week.
  • Distribution of the Johnson & Johnson vaccine has been varied for weeks.
  • About 4.9 million doses were distributed across the United States this week.
  • See more stories on Insider’s business page.

States will only receive 700,000 doses of the Johnson & Johnson COVID-19 vaccine next week, after weeks of varied distribution.

According to the Centers for Disease Control and Prevention, 4.9 million doses of the Johnson & Johnson vaccine were distributed across the United States this week. Last week, about 1.9 million doses were distributed.

The slowdown in distribution comes after a plant in Baltimore mistakenly mixed up vaccine ingredients and ruined 15 million doses of the Johnson & Johnson vaccine. The factory now has to check 62 million other doses for possible contamination and has yet to be cleared to distribute by federal regulators.

The Dutch plant that delivered the initial supply of Johnson & Johnson vaccine doses to the US also distributed doses on a varied schedule, causing a further slowdown across states, according to the New York Times.

As of Friday morning, at least 112 million people in the US, or 33.7% of the population, had received their first doses of the COVID-19 vaccine. More than 66 million people have been fully vaccinated, CDC data shows.

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Officials in Colorado and North Carolina pause distribution of J&J vaccine after minor adverse reactions

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ATHENS, OHIO, UNITED STATES – 2021/03/09: Athens City-County Health Department Director of Nursing, Crystal Jones, 52, loads syringes with the vaccine on the first day of the Johnson and Johnson vaccine being made available to residents. The Athens City-County Health Department collaborated with Ohio University to roll out the new Johnson & Johnson (COVID-19) Vaccine, which only requires one shot instead of two.

  • Less than 1% of Johnson & Johnson vaccine recipients experienced adverse reactions this week.
  • But officials in Colorado and North Carolina are pausing their use of the shot.
  • An investigation is underway to see if there is an issue with the batch being used.
  • See more stories on Insider’s business page.

Officials in Colorado and North Carolina are pausing distribution of the Johnson & Johnson coronavirus vaccine after a few people experienced minor adverse reactions this week.

As The Denver Post reported Wednesday, 11 people experienced reactions after receiving the J&J shot at a mass-vaccination clinic in Commerce City, just north of Denver. With over 1,700 having being given the vaccine that day, that comes out to less than 1%.

On Thursday, Peter Banko, CEO of Centura Health, which was distributing the vaccines, said the company would pause while public health officials investigate whether there is an issue with the batch, The Post’s Meg Wingerter reported.

There were no issues earlier in the week, Wingerter noted.

In North Carolina, public health officials in Wake County reported 14 people – out of more than 2,300 – experienced adverse reactions on Thursday. “Currently the Centers for Disease Control and Prevention are analyzing the vaccine lot and expect to issue guidance within the next two hours,” county officials said Thursday evening.

The reactions, while minimal, come after Johnson & Johnson was forced to scrap some 15 million doses due to a manufacturing error at a plant in Baltimore.

In a statement, Johnson & Johnson told Insider it takes any adverse reactions seriously, saying it will “carefully assess the events” and share any findings with the Food and Drug Administration.

“There is no greater priority than the safety and well-being of the people we serve,” the company said.

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One chart shows which vaccine side effects you can expect based on your age, manufacturer, and dose

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A healthcare worker in the Netherlands receives the Pfizer vaccine on January 6.

  • All three US-authorized coronavirus vaccines can bring mild to moderate side effects.
  • Johnson & Johnson’s shot generally has fewer side effects than Pfizer’s or Moderna’s.
  • Elderly people saw fewer side effects than younger adults across all three clinical trials.
  • See more stories on Insider’s business page.

If you’re getting vaccinated, expect a sore arm.

Pain at the injection site is the most common side effect of all three coronavirus vaccines authorized in the US.

In general, the vaccines produce mild to moderate side effects that shouldn’t last more than a few days. Side effects typically show up within 12 to 24 hours of getting the shot. They’re often a sign that the body is building immunity to the virus.

“It’s important to remember: When people get side effects from vaccines, it’s not really because of the vaccine; it’s more of the body’s immune response to the vaccine,” Dr. Vivek Cherian, an internal-medicine physician in Baltimore, told Insider.

Scroll through the chart below to see which side effects are common based on your age group, which manufacturer’s vaccine you get, and whether you’re on dose one or two. In general, older people experience fewer side effects than younger adults, since our immune response gradually weakens with age. For two-shot vaccines like Pfizer’s and Moderna’s, the second shot amplifies an existing immune response, so people typically feel more run-down after that dose.

Vaccines spur our bodies to produce coronavirus antibodies. But since our immune systems can’t distinguish between a real infection and a vaccine-induced response, they still release inflammatory chemicals to protect us. That’s why people can develop a fever, muscle pain, fatigue, or headaches shortly after their shots.

Johnson & Johnson’s shot has the fewest side effects

Across the board, Johnson & Johnson’s shot has milder and fewer side effects than the other two. Some experts suspect that’s because it’s a single shot.

Nearly 62% of participants younger than 59 in Johnson & Johnson’s trial developed side effects, compared with 45% of people ages 60 and up.

That’s relatively similar to the reported side effects after one dose of Moderna’s vaccine: Around 57% of people younger than 65 in that trial developed side effects, compared with 48% of those older than 65. After the second Moderna dose, however, nearly 82% of people in the younger group developed side effects, compared with nearly 72% of older adults.

But Johnson & Johnson’s shot also seems to be less effective overall: Clinical trials suggest the vaccine is 66% effective at preventing COVID-19. Pfizer’s and Moderna’s vaccines are each more than 90% effective. However, it’s difficult to compare the companies’ trials side-by-side, since they happened at different stages in the pandemic and in different geographic regions.

Coronavirus vaccines are injected into muscle.

Common side effects include fatigue and headache

Once a vaccine goes into your arm, your blood flow increases and immune cells rush to the scene. This can result in pain, redness, or swelling at the injection site.

The reaction is more common after Pfizer’s and Moderna’s vaccines than after Johnson & Johnson’s. Across all age groups, less than 50% of participants in Johnson & Johnson’s clinical trial reported pain at the injection site compared with 92% of Moderna participants and 84% of Pfizer participants.

Headache and fatigue were also relatively common across all the trials. Around 69% of Moderna participants reported headaches compared with 55% of Pfizer participants and 39% of Johnson & Johnson’s.

In both Pfizer and Moderna’s trial, around 63% of participants reported fatigue. Just 38% of participants reported fatigue in Johnson & Johnson’s trial, but the prevalence of those side effects also varied by age.

Younger adults saw more side effects, with a few exceptions

vaccine selfie
A woman snaps a selfie after receiving her vaccine.

Just a few side effects appear to be more or equally as common among elderly participants as younger ones.

After dose two of Pfizer’s vaccine, joint paint was equally common in the two groups, with about 22% to 23% reporting the effect. But after dose two of Moderna’s vaccine, body or muscle aches were more common among adults ages 66 and up (47%) than younger adults (6%).

Though older adults tend to have fewer side effects overall, experts say there’s no reason to believe vaccines won’t work as well among the elderly.

“For the COVID-19 vaccine, we’ve actually not seen decreased effectiveness as we get older, so that’s actually a really good thing,” Cherian said.

Younger people shouldn’t worry too much about feeling strong side effects, either.

“Dealing with a few side effects of some diarrhea or some muscle aches is a much, much better thing to get than some of those serious, potentially life-threatening side effects of the COVID-19 infection,” Cherian said.

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What you can and can’t do once vaccinated that the CDC guidelines don’t tell you

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Elderly-care workers celebrate getting vaccines in Boston, Massachusetts, on December 24, 2020.

With a growing number of states rolling out vaccines to the general public, most US adults could get their hands on a shot by summer, if not sooner. So far, 29% of the US population has received a first dose.

But until a majority of the country has been vaccinated, it’s tough even for vaccinated people to determine what’s safe. Although the Centers for Disease Control and Prevention offers basic guidelines for vaccinated Americans, quite a few common scenarios aren’t addressed in the agency’s recommendations.

For instance, the CDC doesn’t offer advice for households in which only some family members are vaccinated, or for people who’ve received just one vaccine dose. The guidance also stops short of telling vaccinated people whether they can return to indoor activities, and there’s no concrete rule about exactly how many fully vaccinated people can gather indoors without masks.

So we asked physicians to weigh in on a handful of these common yet confusing scenarios. In general, they said, vaccinated people can incur more risk if they live alone or with others who’ve gotten their shots.

Wait to get both shots before changing your behavior

Nurse Robert Orallo administers the Pfizer vaccine at the Blood Bank of Alaska on March 19, 2021.

The CDC doesn’t consider a person to be fully vaccinated until at least two weeks after their second dose of Pfizer’s or Moderna’s vaccine, or two weeks after their single shot of Johnson & Johnson’s. That’s because it takes time for immunity to build.

Dr. Vivek Cherian, an internal-medicine physician in Baltimore, told Insider that it’s not worth the risk to start changing your behavior in between your first and second shot.

“You’d be really only talking about waiting an extra few weeks to get your second dose and reap those benefits,” he said.

Steer clear of large gatherings if you live with unvaccinated people

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A family wearing masks enters a hotel room.

The CDC says it’s alright for vaccinated people to remove their masks when visiting other fully vaccinated people indoors or seeing unvaccinated people from a single household.

“The guidance is fairly straightforward,” Dr. Jonathan Leizman, a family medicine physician and the chief medical officer at Premise Health, told Insider. “What is not always straightforward, though, are real-life circumstances. Split households, where some members are vaccinated and others are not, is one example.”

Physicians generally advise that these households stick to outdoor activities and steer clear of large gatherings until all members have gotten their shots.

For example, Cherian said, in his family, he’s vaccinated but his wife and children aren’t. So they’ve chosen to refrain from activities with crowds – such as birthday parties – even if they’re outdoors.

“Given that our older son is attending a school that is practicing safety against COVID-19 by maintaining learning pods, we feel an even greater ethical responsibility to reduce risk as much as possible,” he said.

Households with high-risk individuals should be extra cautious

woman hugging elderly mother
A woman hugs her elderly mother.

Leizman said it’s important to consider whether unvaccinated people in your household are vulnerable to severe COVID-19. If that’s the case, even the vaccinated person should continue to wear masks in public and ensure any gatherings with people outside the home are social distanced and outdoors.

“In instances where one member of a couple is unvaccinated and does not have risk factors for severe COVID-19, [the couple] may socialize indoors and without a mask with another adult who is fully vaccinated,” Leizman said.

Big groups of fully vaccinated people aren’t necessarily risky

An outdoor wedding.

The CDC recommends that vaccinated people continue to avoid medium and large in-person gatherings – but the agency doesn’t give a specific cutoff for the number of attendees. Experts don’t yet seem to agree about whether multiple households of fully vaccinated people should gather in groups.

“The time for concerts, weddings, and other large-scale events will certainly come, and the risk of creating a superspreader event is certainly lower if participants are vaccinated,” Leizman said. But he added that “vaccination is truly only one part of the public health puzzle.”

For now, he suggested that “fully vaccinated people should avoid these types of gatherings.”

But Cherian said the size of the event isn’t the main issue – it’s whether any unvaccinated people are in attendance.

“If all individuals are fully vaccinated, there is an extremely low risk to those present,” he said. “When you start having larger gatherings and include unvaccinated individuals from many different households, the risk of COVID-19 transmission increases.”

There’s little harm in hopping on a plane if you’re vaccinated

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Travelers wear masks on a plane.

The CDC recommends that fully vaccinated people continue to refrain from non-essential travel, but the guidelines don’t specify which forms of travel are off-limits.

Experts said there’s little risk in hopping on a plane to see friends and family once you’re fully vaccinated.

“Fully vaccinated people should feel free to travel to see their families,” Dr. Leana Wen, an emergency physician in Baltimore, told CNN. “But of course, please take every precaution during the travel – including wearing a well-fitting mask at all times in public places, trying to stay physically distanced where possible, and washing hands well.”

It’s ok to take the subway, but wear your mask

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A man talks on the phone while riding the subway.

Subways, trains, and buses tend to hold large crowds, so riders face a higher risk of COVID-19 exposure. For that reason, the CDC still recommends that Americans limit their use of public transportation if possible, whether they’re vaccinated or not.

Leizman, however, said that vaccinated people can consider taking the subway if they wear masks and practice social distancing whenever possible.

Be selective about high-risk activities like indoor dining or church services

People wearing masks at the gym
People wear masks at the gym.

Wen told CNN that she considers the CDC guidelines for vaccinated people to be “overly cautious” about indoor activities.

“Let’s say that someone is vaccinated and really wants to attend in-person church services and to go back to their senior center for indoor activities,” she said. “The risk to them is very low, and their risk to others is also low.”

The same goes for indoor dining, Wen added: “I’d go so far as to say that a couple that really wants to eat out in a restaurant again could do so occasionally, but not night after night.”

In general, experts recommended that vaccinated people choose the indoor activities that matter most to them, then engage in these activities sparingly until most others are vaccinated as well.

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Company involved in 15 million discarded doses of the J&J vaccine has history of quality control violations

johnson and johnson covid vaccine
Johnson & Johnson’s coronavirus vaccine is delivered as a single shot, while both Pfizer and Moderna’s require two jabs.

  • One of the companies producing the J&J vaccine has a history of quality control violations, AP reported.
  • Emergent Biosolutions was cited by the FDA on quality control issues, including mold and cracked vials.
  • The company is at the center of the mix-up that led to 15 million discarded doses of the vaccine on Wednesday.
  • See more stories on Insider’s business page.

The company at the center of the mix-up that led to roughly 15 million discarded doses of the Johnson & Johnson vaccine has a history of quality control violations, the Associated Press reported.

A manufacturing plant in Baltimore under Emergent Biosolutions, one of eight companies producing the Johnson & Johnson vaccine, spoiled a batch of the Johnson & Johnson vaccine, delaying production and halting future shipments, The New York Times reported Wednesday.

The mishap was due to human error, according to The Times, when workers at the plant mixed up the vaccine ingredients. The Food and Drug Administration is currently investigating the incident.

But the company has been cited on multiple occasions by the Food and Drug Administration for quality control issues, ranging from cracked vials and poorly trained employees to problems managing mold and other contaminants within one of its facilities, according to records obtained by AP through the Freedom of Information Act.

johnson and johnson vaccine
A nurse loads a syringe with a dose of Johnson & Johnson’s COVID-19 vaccine on March 9, 2021 in Athens, Ohio.

When Johnson & Johnson first went to Emergent in April of last year to produce their vaccine, Emergent’s Bayview facility was described as a contract testing laboratory that “did not manufacture products for distribution,” according to FDA records obtained by the AP. At the time, it also didn’t have the capacity for making millions of doses of the COVID-19 vaccine.

In a recent inspection, the FDA cited the company’s Bayview plant on “data integrity concerns” after a review found that the facility had failed to ensure that electronic testing data “was protected from deletion or manipulation,” the AP reported.

The Bayview plant was criticized for not following proper testing and lab procedures, according to the report. The FDA also cited the facility for not having a proper method for discarding rejected materials after an inspector wrote that “separate or defined areas to prevent contamination or mix-ups are deficient” at the plant.

In December 2017, another Emergent plant in Canton, Massachusetts, was also cited for not correcting “continued low level mold and yeast isolates” found in the facility.

A 2018 inspection of the company’s Baltimore facility found that “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed,” according to the AP report.

A spokesman for the FDA told the AP that the agency “cannot comment on any particular company or any potential or ongoing compliance matters.”

Representatives from Emergent did not immediately return Insider’s request for comment regarding the report, but Emergent spokesman Matt Hartwig told AP in a statement that the company’s “rigorous quality checks” found the spoiled batch that did not meet its standards.

johnson and johnson vaccine
The first boxes of the Johnson & Johnson Covid-19 vaccine are loaded into a box for shipment from the McKesson facility in Shepherdsville, Kentucky on March 1, 2021.

“Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” he wrote in the email to AP.

Despite the factory mixup, the Biden administration still expects to reach its goal of having enough vaccines to make every American adult eligible for a vaccine by the end of May, The Times reported.

White House Press Secretary Jen Psaki said Thursday that none of the already available doses of the Johnson & Johnson vaccines were impacted by the factory mixup, and that the company still expects to deliver 24 million doses in April and 100 million doses by the end of May.

“Obviously, these are doses that the U.S. government has purchased, but we also have plenty of doses from Pfizer and Moderna regardless,” Psaki said.

In an interview on “CBS This Morning,” top US infectious disease expert Dr. Anthony Fauci responded to the incident, saying that “human errors do happen.”

“The good news about this, despite the fact that it’s really quite unfortunate that about 15 million doses are not going to be able to be used, you do have checks and balances, and you see that,” Fauci said, “and that’s the reason why the good news is that it did get picked up.

“That’s the reason that nothing from that plant has gone into anyone that we’ve administered to,” Fauci continued.

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The CEO of the biotech firm that ruined Johnson & Johnson vaccine doses told CNBC ‘it was one batch’

johnson and johnson vaccine
A nurse loads a syringe with a dose of Johnson & Johnson’s COVID-19 vaccine on March 9, 2021 in Athens, Ohio.

During an interview on CNBC’s Closing Bell on Thursday, Emergent BioSolutions CEO Bob Kramer said that it was “unfortunate,” that a mixup occurred at its Baltimore facility producing Johnson & Johnson and Astrazeneca COVID-19 vaccines.

“It’s one batch,” Kramer repeated when pressed on what exactly went wrong, not specifying or confirming whether that batch amounted to 15 million doses.

A mishap at Emergent BioSolution’s Baltimore production facility reportedly spoiled around 15 million doses of Johnson & Johnson’s vaccine.

The New York Times first reported the incident. Senior Biden administration officials later confirmed to the Times and Politico that the mixup affected the timing of future shipments of the vaccine.

On CNBC Thursday, Kramer pushed back on the report, saying there wasn’t cross-contamination of ingredients, but that doses were pulled because of an “out of specification result for one batch of product.”

“It isn’t the case that an ingredient from one impacted the other, one batch of product was determined to be inconsistent, and was pulled aside,” he told CNBC.

Kramer said he doesn’t expect a significant delay in FDA authorization for production at the Emergent BioSolutions plant in Baltimore.

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Roughly 15 million doses of the Johnson & Johnson vaccine were ruined because of a factory mixup, report says

johnson and johnson vaccine
The first boxes of the Johnson & Johnson Covid-19 vaccine are loaded into a box for shipment from the McKesson facility in Shepherdsville, Kentucky on March 1, 2021.

A mishap at Emergent Biosolutions, a manufacturing plant in Baltimore that produces two separate coronavirus vaccines – Johnson & Johnson and AstraZeneca – has spoiled close to 15 million doses of Johnson & Johnson’s vaccine and has delayed production and shipment schedules for weeks, according to The New York Times.

According to the report, the mixup was due to human error, when workers mixed up the ingredients of the vaccines. The report added that the Food and Drug Administration is investigating the incident, and the mixup means that Johnson & Johnson has halted future shipments of its vaccine.

The mistake does not affect Johnson & Johnson vaccines that have already been delivered. According to the report, federal officials still expect to have enough vaccines to meet President Joe Biden’s promise of every American adult being eligible to receive a vaccine by the end of May.

The facility was expected to produce tens of millions of doses of the Johnson & Johnson vaccine in the coming months.

J&J’s shot won US authorization on February 27. Since then, company executives have repeatedly said they are on track to deliver 20 million doses to the US by the end of March and 100 million doses by the end of June. Overall, J&J aims to produce 1 billion doses in 2021.

J&J did not immediately respond to an Insider request for comment, including if they still expect to meet those commitments.

The company issued a statement on Wednesday evening, which said, “We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States,” adding that current production rates are, “part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.”

The statement added, “As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.”

“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process,” the statement added.

According to Politico, US officials confirmed that the mixup took place and said would affect future shipments of the J&J vaccine.

The Biden administration reportedly asked J&J to directly supervise vaccine production at the Emergent BioSolutions facility going forward, and Politico reported that having the facility back up to regulatory standards could take days, or even weeks.

The company’s vaccine has been applauded by public health experts for its simple logistics. It’s given as a single dose and can be stored at typical refrigerator temperatures for several months.

Last summer, J&J signed a five-year deal with Emergent BioSolutions, a contract manufacturer, to help boost the production of its COVID-19 vaccine. The first two years of the agreement were valued at $480 million, the companies said.

Emergent is a $5 billion, Maryland-based contract manufacturer that is producing both J&J’s and AstraZeneca’s coronavirus vaccines. To build up its own capacity, the company hired about 700 new workers in 2020, with at least 250 brought aboard for COVID-19 work, according to its latest annual corporate filing. Emergent did not immediately respond to a request for comment from Insider. Its stock was down about 5% Thursday in after-hours trading.

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The COVID-19 vaccine side effects you can expect based on your age, sex, and dose

San francisco vaccine line
Alameda County workers line up to receive coronavirus vaccines outside St. Rose Hospital in Hayward, California, on January 8, 2021.

  • COVID-19 vaccine side effects can vary depending on a person’s age, sex, or health status.
  • Women and younger adults tend to have more side effects than men or older adults do.
  • Side effects are generally more pronounced after the second dose than the first.
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When Freedom Baird got her first dose of Moderna’s vaccine in February, she wasn’t sure what kind of side effects to anticipate.

Baird is a COVID-19 long-hauler – she’s had lingering shortness of breath and chest pain for roughly a year. Many people who’ve had a prior infection develop more side effects in response to the first vaccine dose than the second. An average person, meanwhile, typically feels more run-down after their second shot.

Baird’s age complicated her expectations: She’s 56, and clinical trials have shown that people over 55 often develop fewer vaccine side effects. As it turns out, she didn’t feel much.

“It was really just that first day of feeling achy and flu-y,” Baird told Insider.

While doctors can’t predict exactly how someone will respond to a coronavirus vaccine, they’ve identified a few patterns based on a person’s age, sex, health status, and which dose they’re receiving. Clinical trials suggest that side effects are generally more pronounced among women and younger adults, especially after their second dose.

Dose two usually comes with more severe side effects

COVID Vaccine
A vaccine vial.

The most common side effect for all three authorized US vaccines is pain or swelling at the injection site: Nearly 92% of participants in Moderna’s clinical trial developed this side effect. in Pfizer’s trial, 84% of participants reported that, as did 49% in Johnson & Johnson’s.

Other common side effects include fatigue, headache, and body or muscle aches. Around 65% of vaccine recipients in Pfizer’s and Moderna’s trials, and 38% in Johnson & Johnson’s, developed fatigue.

For those who haven’t had COVID-19 before, side effects tend to be more numerous and severe after the second dose.

Roughly twice as many participants in Pfizer’s trial developed chills and joint pain after their second dose than after their first. In Moderna’s trial, meanwhile, around five times as many participants developed chills after their second dose than their first. Fevers were also far more common among second-dose recipients than first-dose recipients in both trials.

People who’ve had COVID-19 may develop more side effects after dose 1

A small study from the Icahn School of Medicine at Mount Sinai found that vaccine side effects such as fatigue, headaches, and chills were more common among people with pre-existing immunity to the coronavirus than people who’d never been infected before. Around 73% of vaccine recipients who’d previously had COVID-19 developed side effects after dose one of Pfizer’s or Moderna’s shot, compared to 66% of vaccine recipients who’d never gotten infected before.

“If you’ve already had a COVID-19 infection, you’ve developed memory cells from that infection,” Dr. Vivek Cherian, a Baltimore-based internal medicine physician, told Insider.

“If you were ever to be exposed to the infection again, your body would basically be able to respond quickly and more robustly that second time around,” he added. “That’s why you tend to have more strong side effects from that initial vaccine.”

Younger adults may feel more run-down after their shots than older people

woman receiving covid vaccine
A woman receives a COVID-19 vaccine in Wales.

Our immune systems gradually deteriorate as we age, which means older people’s bodies don’t work as hard to defend them against foreign invaders – including the protein introduced to the body via a vaccine.

“Younger individuals have a much more vigorous immune response, so it should make sense that they would also have more side effects,” Cherian said.

After one dose of Moderna’s shot, 57% of people younger than 65 developed side effects, compared to 48% of those older than 65. After the second dose, nearly 82% of people in the younger group developed side effects, compared to nearly 72% of older adults.

Pfizer broke down its data slightly differently: Around 47% of people ages 18 to 55 developed fatigue after dose one, whereas 34% of people ages 56 and older reported that side effect. After dose two, the numbers rose to 59% and 51%, respectively.

After Johnson & Johnson’s one-shot vaccine, nearly 62% of people ages 18 to 59 developed side effects, compared to 45% of people ages 60 and up.

Women can expect more side effects in general

coronavirus vaccine recipient
A woman receives a COVID-19 vaccine.

The Centers for Disease Control and Prevention analyzed Americans’ reactions to nearly 14 million doses of the Pfizer and Moderna shots from December to January. The results showed that roughly 79% of instances of vaccine side effects reported to the CDC came from women, though just 61% of doses were administered to women overall.

Cherian said women tend to react more strongly to vaccines for polio, influenza, measles, and mumps as well.

“All of these vaccines in general, women tend to have greater side effects,” he said. “They’re even more pronounced for a pre-menopausal woman compared to a post-menopausal woman.”

Scientists suspect the difference has to do with estrogen levels.

“Testosterone tends to be an immune-suppressive hormone and estrogen tends to be an immune stimulant,” Cherian said. “So more than likely it’s the estrogen hormone – that’s why females tend to have more side effects.”

Most high-risk medical conditions won’t lead to stronger side effects

covid vaccine elderly
CVS pharmacist Gina Glancy gives the second dose of Pfizer’s COVID-19 vaccine to Bob Jensen, 89, in West Chester, Pennsylvania.

People with weakened immune systems don’t mount a strong defense against viral infections in general, so they’re particularly vulnerable to severe COVID-19. For that reason, the CDC recommends that these groups get vaccinated right away.

But it’s possible that immunocompromised people, such as cancer patients, won’t mount a strong immune response to the vaccine, either.

“Your immune response essentially dictates your side effects, so if you’re immunocompromised, you may not necessarily be having as many side effects, but you should still absolutely get vaccinated,” Cherian said.

The vaccines should provide immunocompromised people with at least some protection against severe COVID-19, even if they don’t feel any side effects – though the effectiveness may be lower than for the average person.

Cherian said that for people with autoimmune conditions, meanwhile, the side effects probably won’t be any worse than for the average person.

“If you have those high risk factors, you really, really want to get vaccinated,” he said. “Dealing with a few side effects of some diarrhea or some muscle aches is a much, much better thing than some of those serious, potentially life-threatening side effects of the COVID-19 infection.”

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