EU Drug Regulator Says Clot ‘Very Rare’ Johnson & Johnson’s Vaccine Side Effect

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Europe’s medicines regulator mentioned Tuesday that blood clots needs to be listed as a “very uncommon” side effect of Johnson & Johnson’s coronavirus vaccine, but that the benefits of the shot still outweighed the risks. The United States is expected to announce its decision on the single-shot J&J vaccine by Friday, as nations around the world urgently try to accelerate inoculation campaigns and revive their pandemic-ravaged economies.

The European Medicines Agency (EMA) assessment came as an EU official promised to have enough doses available to vaccinate 70 percent of European adults by the summer — a boon for the continent’s sluggish rollout. Europe’s Johnson & Johnson campaign was delayed after US health regulators said the shot should be paused over blood clot fears.

After reviewing isolated cases of clotting among people who received the vaccine, EMA’s safety committee said it found a “possible link” to the jab.

The regulator mentioned its security committee “concluded {that a} warning about uncommon blood clots with low blood platelets needs to be added to the product info” for the J&J shot.

“This is a very rare effect,” EMA chief Emer Cooke instructed reporters. “But it additionally makes it crucial for docs and sufferers to concentrate on the indicators in order that they’ll spot any considerations.”

Italy’s health authorities said that in light of the EMA ruling, the vaccine should be considered “definitively safe” however the nation would prioritise its use for folks aged over 60.

‘We remain confident’

Only two international locations had began administering the J&J shot earlier than it was paused — the United States and South Africa — with greater than seven million doses given out to date, in line with an AFP tally.

The vaccine was praised as simpler to manage and transport than a few of its rivals, as a result of it requires only one dose and could be saved at hotter temperatures.

The EU accepted the J&J shot on March 3 and began taking deliveries on April 19, however has not but began administering it to folks.

A high Johnson & Johnson govt mentioned Tuesday he hoped for a speedy decision to the present pause.

“We stay very assured and really hopeful that the benefit-risk profile will play out,” Chief Financial Officer Joseph Wolk told CNBC.

The J&J concerns follow similar reports of blood clots in a very small number of people who received the AstraZeneca shot.

The EMA also described those clots as a “very rare” aspect impact, stressing that the AstraZeneca jab’s advantages outweigh the dangers.

Europe’s leaders are eager to speed up vaccinations and increase availability after dealing with intense criticism over a gradual rollout and with the general public determined for a return to a point of normality.

Thierry Breton, the EU’s inner markets commissioner, instructed French newspaper Le Figaro the bloc was now set to have sufficient doses to cowl 70 % of its grownup inhabitants by mid-July.

The Dutch authorities mentioned Tuesday it will finish its coronavirus curfew and permit cafes to serve open air throughout restricted hours from April 28.

Elsewhere there was much less purpose for hope.

Moscow’s mayor Sergei Sobyanin introduced a drive to get aged residents vaccinated to keep away from a lockdown, acknowledging the deteriorating scenario there.

‘Like a storm’

And India, house to 1.3 billion folks, is battling a worrying surge, with document day by day case numbers overwhelming already stretched hospitals.

The capital New Delhi was locked down Monday for every week, and the federal government mentioned all adults could be eligible for a vaccine from May because it tries to get a grip on the disaster.

In a televised handle Tuesday, Prime Minister Narendra Modi acknowledged that this second wave had hit India “like a storm”.

“It is a big challenge, but we have to — together, with our courage and determination — overcome it,” he added.

The Delhi lockdown follows strict measures already imposed in different Indian states.

The US Centers for Disease Control on Monday suggested towards all journey to India, and the UK imposed restrictions on arrivals from the nation.

India’s crematoriums and gravediggers have been overwhelmed.

Social media and newspapers have been flooded with horrifying photos of row upon row of burning pyres. At a cemetery in New Delhi, gravedigger Shamim instructed AFP: “At this charge, I’ll run out of house in three or 4 days.”

Hard-hit Brazil meanwhile now has the leading overall death rate in the Americas and the entire southern hemisphere, according to AFP data.

With 176 deaths per 100,000 people since the beginning of the outbreak, Brazil has recently overtaken Peru with 174 per 100,000 and the US with 172 per 100,000.

There was growing concern about a spike in Japan, where the third most populated region, Osaka, on Tuesday asked the central government to impose a state of emergency with infections rising just three months before the country hosts the Olympics.

Tokyo and several other areas are expected to follow suit, hoping to avoid Osaka’s plight, where hospital beds for seriously ill coronavirus patients have run out.

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