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World COVID-Vulnerable Groups Dealt Setback With Vaccine as Europe Largely Halts Johnson & Johnson Shot

21:35  14 april  2021
21:35  14 april  2021 Source:   newsweek.com

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European countries face an increased delay to the already-slow COVID-19 vaccine rollout after U.S. health officials halted the use of the Johnson & Johnson vaccine after reports of blood clots.

a sign on the side of a building: General exterior view of the head office of Janssen pharmaceutical company on Februyary 5, 2021 in Leiden, Netherlands. The American mother company of Janssen, Johnson & Johnson has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. Johnson & Johnson announced Tuesday that it will delay distribution of its vaccine in Europe over concerns of a potential link to blood clots. © Niels Wenstedt/BSR Agency/Getty Images General exterior view of the head office of Janssen pharmaceutical company on Februyary 5, 2021 in Leiden, Netherlands. The American mother company of Janssen, Johnson & Johnson has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. Johnson & Johnson announced Tuesday that it will delay distribution of its vaccine in Europe over concerns of a potential link to blood clots.

Johnson & Johnson announced Tuesday in a news release that it will temporarily suspend the distribution of its vaccine in Europe. The continent already faced a similar pause in the distribution of the AstraZeneca vaccine in March due to a potential link to blood clots.

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The Johnson & Johnson vaccine, distributed in Europe by its subsidiary Janssen, is the only one of the four approved vaccines in Europe that requires just a single dose. This makes it an ideal choice for hard-to-reach, vulnerable populations like homeless people and migrant workers.

According to the European Parliament, there were more than 700,000 unhoused people in Europe in 2020, an increase of 70 percent over the last decade.

"The COVID-19 crisis puts homeless people at additional risk, as they disproportionally suffer poor health and lack access to hygiene and health care. With the current economic recession and jobs losses, homelessness rates could increase," a report from the European Parliament said.

A recent study from the Joint Research Centre (JRC) found that about 13 percent of all key workers in the European Union are migrants, although in some specific sectors, the share of migrants is much higher.

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According to the study, the share of migrant workers is particularly high in key low-skill jobs, such as personal care workers in health services, drivers, transport and storage workers, as well as food-processing workers.

"The fight against coronavirus has unveiled the relevance of migrant workers in many occupations. This aspect is often overlooked, if not dismissed, in the debates on legal migration predominantly focused on the importance of attracting high-skilled migrants to the Union," JRC researcher Jacopo Mazza said.

For more reporting from the Associated Press, see below.

The European Medicines Agency, the EU's regulatory agency for pharmaceutical products, has not advised EU members to put the Johnson & Johnson vaccine on hold. It said Wednesday: "The company (J&J) is in contact with national authorities, recommending to store the doses already received until the PRAC (EMA's safety committee) issues an expedited recommendation."

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It's not clear if the exceedingly rare reports in the U.S.—so far, six cases out of about 7 million inoculations—are linked to the Johnson & Johnson vaccine. But European regulators already have declared that the unusual type of clots are possibly linked to the AstraZeneca-BioNTech vaccine, which is made with technology similar to Johnson & Johnson's product.

The AstraZeneca vaccine is in wide use around the globe, though not yet in the U.S. Several countries have imposed age restrictions on its use because of the clot concerns. Denmark, which put the vaccine on hold last month, decided Wednesday not to resume using the shots it had on hand, saying that citizens who had received a first dose would be offered a second dose of a different vaccine.

Still, experts agree COVID-19 poses a much larger risk of death and hospitalization than the potential threat of atypical clots. But the concerns could still undermine public confidence in these vaccines and in the entire vaccination effort.

The EMA, which approved the vaccine last month, said Wednesday that it will make a recommendation likely next week on how to proceed with the vaccine.

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  America is about to hit a 'vaccine wall' as demand drops — with or without Johnson & Johnson When U.S. officials temporarily paused the use of Johnson & Johnson’s COVID-19 vaccine Tuesday to warn patients and providers of an “extremely rare” blood clotting issue that has so far affected just six of the millions of Americans who have received the vaccine — all six of them women ages 18 to 48 — many observers worried the abrupt move would stop a substantial number of Americans from getting vaccinated. Because even before the J&J news, theBut if you take a closer look at the data, it’s clear that unless regulators end up pulling J&J from the market — an outcome experts have all but ruled out, given the vaccine’s robust track record of safety and effectiveness and the relatively minuscule risk of clotting — th

Until then, the regulator said that it "remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects."

For Poland, that meant there was no reason to wait.

"In line with these recommendations (by the EMA), we will want to use it in inoculations," Polish Health Minister Adam Niedzielski said.

France, which received 200,000 doses, said it is also sticking to its plan to start administering the vaccine in the middle of next week to people age 55 and over. Hungary also said it would move ahead with the doses it received. It plans to distribute them using buses that bring vaccines to rural areas.

Other countries, however, decided to hold up.

Italian Health Minister Roberto Speranza said his government was waiting for further information from the FDA and the EMA to decide how to proceed with the initial 180,000 doses that arrived in Italy Tuesday.

"But I think this vaccine must be used because it's an important vaccine, and the U.S. decision was a precautionary one, and the choice of Johnson & Johnson to not immediately put it on the market in Europe was also a precautionary choice," Speranza said.

"Our hope is that these knots can be resolved as soon as possible so we can use this vaccine, which would be the fourth one and is particularly useful for us," he said.

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The Netherlands also put the 80,000 Johnson & Johnson doses it received into storage, as did Denmark, Croatia and Romania with their batches. South Africa suspended the shot as a "precautionary measure."

The European Union has for weeks been looking at Britain with envy as the vaccination program of its former member outpaced its own.

The J&J shot was supposed to help it play catch-up.

Under a contract with the European Commission, 200 million doses were supposed to arrive in the second quarter of this year. That deal allowed for the purchase of an additional 200 million doses.

Despite this week's delay, Spanish Prime Minister Pedro Sánchez said the EU was still on track to vaccinate 70% of adults by the end of the summer. Spain—which received an initial shipment of 146,000 doses that are now on hold—planned to use the shots to target groups that have been missed so far, including homeless people and migrant workers.

Austrian Chancellor Sebastian Kurz also downplayed the impact of the delay that came hours after the first doses were delivered to his country.

"I can only tell you that, with the more than 8 million doses we will have delivered by the summer...we will be able to able to offer everyone a first dose. I said at Easter within 100 days, and from today's point of view I would stick to that," Kurz said.

In a sign of the bloc's current thinking, European Commission President Ursula von der Leyen announced Wednesday that the bloc will start negotiating to buy 1.8 billion doses of the Pfizer-BioNTech vaccine through 2023.

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'The benefits outweigh the risks': It's time to allow J&J's COVID-19 vaccine again, public health experts say .
A government advisory committee will meet Friday to determine whether to lift the hold on the single-dose vaccine hailed as a "game-changer."A number of experts said they expect a government advisory committee, which will meet Friday for the second time in less than two weeks, to lift the hold on the shot. Depending on what it learns about a mysterious blood clotting ailment, the committee might add an age restriction or simply a warning label to the vaccine.

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