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The Latest: Johnson & Johnson delays shot rollout in Europe

Tuesday, April 13, 2021 | The Associated Press


Boxes of Janssen vaccines sit at a warehouse of Hungaropharma, a Hungarian pharmaceutical wholesale company, in Budapest, Hungary, after the arrival of the first batch of the Johnson & Johnson, US, made one-dose vaccine against the new coronavirus in the country Tuesday, April 13, 2021. The first shopment contains 28 thousand doses of Janssen. (Szilard Koszticsak/MTI via AP)

BERLIN — Johnson & Johnson says it is delaying the rollout of its coronavirus vaccine in Europe amid a U.S. probe into rare blood clots.

The announcement came after regulators in the U.S. say they were recommending a “pause” in administration of the single-dose shot to investigate reports of potentially dangerous blood clots.

“We have been reviewing these cases with European health authorities,” the company said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

The delay is another blow to vaccination drives in European Union member nations, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots in a small number of people who received the AstraZeneca vaccine.

The blood clot reports prompted several countries in the 27-nation bloc to limit the AstraZeneca vaccine to older age groups, who are more at risk from serious illness when infected with the coronavirus.

The European Medicines Agency, the EU’s equivalent to the FDA, says it is having its safety committee investigate these J&J blood clot cases “and will decide whether regulatory action may be necessary.”

The EU ordered 200 million doses of the Johnson & Johnson vaccine in 2021. Britain ordered 30 million doses of the J& J shots, although U.K. regulators have not yet approved its use.

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THE VIRUS OUTBREAK:

— US suggests ‘pause’ on Johnson & Johnson shots over blood clot reports

— Muslims open Ramadan with communal prayers in socially distanced contrast to empty mosques of a year ago

— India reels from explosive virus surge, affecting world vaccine supply

— Emptied by the pandemic, Canary Islands hotel offers shelter to migrants in need

— Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine

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HERE’S WHAT ELSE IS HAPPENING:

WASHINGTON — The Pentagon says it is immediately pausing the use of the single-dose Johnson & Johnson COVID-19 vaccine, amid reports of potentially dangerous blood clots.

The announcement came as Johnson & Johnson says it was delaying the rollout of its vaccine in Europe, and U.S. regulators recommended a “pause” in the administration of the shot.

“The safety of our force and their families is a top priority for the Department,” says Pentagon spokesman John Kirby, adding the department is reviewing it distribution of vaccines to address the issue and continue to provide shots to defense personnel.

In a joint statement, the Centers for Disease Control and Prevention and the Food and Drug Administration announced it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts. More than 6.8 million doses of the J&J vaccine have been administered in the U.S.

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PARIS — France suspended all flights from Brazil on Tuesday amid mounting fears over the particularly contagious coronavirus variant that has been sweeping the South American country.

Prime Minister Jean Castex announced the suspension to parliament.

Although France has seen comparatively few known cases of the P.1 variant striking Brazil, the ravages it is causing in Latin America’s largest nation are increasingly raising alarm bells in France.

Castex noted travelers from Brazil already needed to test negative for the coronavirus before their departure and upon arrival in France and quarantine for 10 days. But the government has been facing mounting calls from health experts for a flight suspension to further limit potential spread.

The country is struggling with another wave of coronavirus infections and hospitalizations that is straining hospitals in Paris and elsewhere.

France has reported 5.1 million coronavirus cases since the pandemic began, the highest number in Europe, and 99,000 confirmed deaths.

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NEW DELHI — India is experiencing its worst pandemic surge, with average daily infections exceeding 143,000 in the past week.

The spike is particularly alarming because India is a major vaccine producer and a critical supplier to the U.N.-backed initiative that aims to help distribute shots fairly. Already the rise in cases has forced India to focus on satisfying its domestic demand and delay deliveries elsewhere.

When infections began plummeting in India in September, many concluded the worst had passed. Masks and social distancing were abandoned, while the government gave mixed signals about the level of risk. Then cases began rising again in February.

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WASHINGTON — The Food and Drug Administration says it expects a short pause of Johnson & Johnson vaccines while regulators investigate reports of potentially dangerous clots in a small number of patients.

Dr. Janet Woodcock, the agency’s acting commissioner, says, “We expect it to be a matter of days for this pause.”

The U.S. FDA and the Center for Disease Control and Prevention recommended the pause Tuesday to investigate unusual clots in six women that occurred 6 to 13 days after vaccination with the J&J vaccine. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All cases were in women between the ages of 18 to 48.

Nearly 7 million J&J doses have been administered in the U.S., almost all without serious side effects.

Regulators say they want to educate patients and medical professionals about spotting and treating the clots. The clots were observed along with reduced platelet counts, making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”

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WASHINGTON — President Joe Biden and former President Barack Obama are appearing in a TV special airing Sunday to help educate, raise awareness and dispel concerns about COVID-19 vaccines.

NBC’s announcement that it will air “Roll Up Your Sleeves” came hours after the U.S. on Tuesday recommended pausing the use of Johnson & Johnson’s single-dose COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

During the hourlong program, Biden will stress the importance of getting vaccinated and feature Dr. Anthony Fauci, the U.S. top expert on infectious disease.

Obama will appear alongside former NBA players Charles Barkley and Shaquille O’Neal. Former first lady Michelle Obama will appear with Faith Hill, Jennifer Lopez and Lin-Manuel Miranda.

“Roll Up Your Sleeves” is presented by Walgreens and created by the media company ATTN in partnership with Civic Nation’s Made to Save initiative.

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WASHINGTON — A White House coronavirus adviser says the pause on the Johnson & Johnson vaccine by the FDA and CDC “will not have a significant impact” on the overall vaccination plan in the U.S.

Jeff Zients, the White House COVID-19 Response Coordinator, says “We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.”

The CDC and FDA announced Tuesday they recommended a pause in the use of the Johnson & Johnson vaccine as they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J%J vaccine.

Zients says in a statement the Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States so far.

“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines,” Zients says.

He adds that’s more than enough supply to continue the current pace of vaccinations of 3 million shots per day and meet the President’s goal of 200 million shots by his 100th day in office.

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LONDON -- Britain has begun offering coronavirus vaccinations to anyone over 45 after hitting its target of giving at least one dose to everyone over 50 by the middle of April.

The government says all residents over 50, health care workers and people with serious medical conditions had been offered a shot, and about 95% have received one.

As a result, the government launched the second phase of its inoculation campaign on Tuesday by expanding eligibility to people 45 to 49.

Despite the good news, British Prime Minister Boris Johnson warned the U.K. would inevitably see “more hospitalization and deaths” as it emerges from lockdown.

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MADRID — Spanish Prime Minister Pedro Sánchez says the benefits of taking the Johnson & Johnson vaccine are greater than the risks.

Sánchez was asked about U.S. move to pause the J&J vaccine during his presentation of Spain’s plans for the EU recovery funds.

The prime minister says he would have to inform himself of the situation, but “we have to all be aware that all the vaccines being administered to the Spanish population, and the European, as well as American populations, are safe.”

“They all count on all the guarantees they need, and the balance between benefit and risk is clearly on the side of taking the vaccine,” Sánchez says.

Spain is expecting to receive 300,000 doses of the J&J vaccine on Wednesday, the first delivery of the shots made by the Janssen subsidiary. The country had planned to prioritize people ages 70 and 79 to receive the single-dose vaccine.

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HOUSTON -- Several large vaccination sites in Texas will temporarily stop offering Johnson & Johnson’s vaccine after federal officials recommended a pause in its administration.

Top county officials in Houston and Dallas say Pfizer or Moderna vaccines will be offered instead of Johnson & Johnson at their large vaccination sites.

In Dallas, officials indefinitely postponed the launch of a program to begin Tuesday that offered the J&J vaccine to homebound individuals and the elderly.

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WASHINGTON — The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred in the days after vaccination. The clots were observed along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”

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

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases. The FDA has launched an investigation into the cause of the clots and low platelet counts.

Previously, concern about the unusual blood clots centered on the AstraZeneca vaccine, which has not yet received authorization in the U.S.

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LISBON, Portugal — Portuguese health experts are warning that the number of coronavirus cases is on the rise as the government mulls whether to continue easing a lockdown that began in mid-January.

The incidence rate per 100,000 people over 14 days has climbed to 71, up from 63 a week ago.

Health experts say within a month the incidence rate — a key pandemic metric — could reach 120, which is the red line when the government says it will stop easing lockdown limits.

The staggered emergence from lockdown is due to reach Phase Three next Monday, when Portugal hopes to reopen all schools, cinemas and shopping malls. That plan could be put on hold if cases keep rising.

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BERLIN — The German government says companies will need to offer all employees who aren’t working from home at least one coronavirus test each week.

The requirement approved by the Cabinet on Tuesday is part of the government’s efforts to drive down persistently high rates of infection in recent weeks.

The government also wants parliament to pass a bill that would shift more powers to set pandemic restrictions in regions with high numbers of cases from state to federal authorities.

Germany’s disease control agency reported 10,810 new confirmed cases in 24 hours and 294 more deaths. Since the start of the pandemic, Germany has registered more than 3 million confirmed cases and 78,746 virus-related deaths.

The country’s sluggish vaccine program picked up last week, with the start of shots in doctors’ offices. Last week, some 3.2 million doses were administered in Germany, compared with 1.9 million the previous week.

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LONDON — Britain says it has hit its target of giving at least one dose of vaccine to everyone over 50 and others in groups at highest risk from the coronavirus by mid-April.

The government says everyone in those groups has been offered a jab, and about 95% of eligible people have received a shot.

More than 32 million people, over 60% of adults, have had a first shot and almost 15% of people in the U.K. have had both doses.

On Tuesday the vaccination drive was expanded to people aged 45-49, the start of the second phase of the inoculation campaign.

Britain has had Europe’s worst coronavirus outbreak, with more than 127,000 confirmed deaths. But rapid vaccination, and a nationwide lockdown have sharply decreased infections and deaths.

Lockdown restrictions are now being lifted, with nonessential shops, hairdressers, gyms and pub and restaurant patios reopening in England on Monday.

Health authorities are also concerned about new variants that are more resistant to the vaccines. They are calling for everyone living in two boroughs in south London to get tested after 44 cases of a strain first identified in South Africa were confirmed there.

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COPENHAGEN, Denmark — Danish Health Minister Magnus Heunicke says 104,824 people were vaccinated in one day as Denmark Monday tested its system ahead of a June rollout where 400,000 will be vaccinated per day.

“The result is now being evaluated, so we are ready for continued effective rollout,” Heunicke wrote on Twitter Tuesday.

Stephanie Lose, head of the Danish Regions, an interest organization for Denmark’s five regions running health care across the country of nearly 6 million, noted that there were some local problems to be solved, including access, parking, logistics and some minor IT issues. In addition, queues occurred in several places because many showed up too early.

Denmark inoculated people in 68 vaccine centers. The number of jabs was lowered again on Tuesday.

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GENEVA — The U.N. health agency is calling on countries to suspend the sale of live animals captured from the wild in food markets as an emergency measure, saying wild animals are a leading source of emerging infectious diseases like the coronavirus.

The World Health Organization issued new guidance on Tuesday saying that animals — particularly wild animals — “are the source of more than 70 percent of all emerging infectious diseases in humans, many of which are caused by novel viruses.”

The coronavirus’s origins more than a year ago have been the source of intense speculation, much of it centered around the likelihood that it was carried by bats and passed to humans through an intermediary species sold as food or medicine in traditional Chinese wet markets. The pandemic first appeared in the city of Wuhan, China.

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Companies Mentioned in This Article

CompanyMarketRank™Current PricePrice ChangeDividend YieldP/E RatioConsensus RatingConsensus Price Target
Johnson & Johnson (JNJ)2.3$170.39+0.1%2.37%26.79Buy$185.70
Pfizer (PFE)2.1$40.11+0.2%3.89%25.88Hold$39.94
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