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April 21, 2021

Modi asks Indians to do better to stop virus surge; Dutch to end Covid curfew; EMA links Johnson & Johnson vaccine to blood clots


April 21, 2021

THE HAGUE: Blood clots should be listed as a "very rare" side effect of the Johnson & Johnson coronavirus vaccine but its benefits still outweigh the risks, the EU’s drug watchdog said on Tuesday.

The European Medicines Agency (EMA) said in a statement that it had found a "possible link" between the jab and the clots, following eight such cases in the United States, one of which was fatal.

Concerns over the vaccine by US pharmaceutical giant Johnson & Johnson and the jab by rival drugmaker AstraZeneca have dampened hopes that vaccines could offer a swift end to the pandemic.

"EMA finds possible link to very rare cases of unusual blood clots with low blood platelets," the Amsterdam-based agency said in a statement, adding that it "confirms (the) overall benefit-risk remains positive."

The regulator said its safety committee "concluded that a warning about unusual blood clots with low blood platelets should be added to the product information" for the J&J shot. Its experts also "concluded that these events should be listed as very rare side effects of the vaccine."

"The cases reviewed were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca, Vaxzevria," the EMA statement said. The eight cases in the US, out of some seven million people who had received the vaccine, all involved people under the age of 60, the majority of whom were women, it said.

"Based on the currently available evidence, specific risk factors have not been confirmed," the EMA said. EMA chief Emer Cooke was due to hold a press conference on the decision at 1500 GMT.

Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe. J&J said earlier on Tuesday that it was "very confident" in its vaccine and hopeful for a quick resolution from regulators over its status.

The EU approved the Johnson & Johnson shot on March 11 and started taking delivery of the vaccine on April 19. But with concerns already mounting over clots linked to AstraZeneca, the EMA announced on April 9 that it was also probing cases connected to the J&J vaccine.

US regulators have suspended the Johnson & Johnson vaccine and is set to announce its decision on Friday. Both the Johnson & Johnson and AstraZeneca vaccines use the same adenovirus vector technology.

They use a common-cold causing adenovirus, modified so it cannot replicate, as a "vector" to shuttle genetic instructions into human cells, telling them to create a protein of the coronavirus, and training them to be ready for live Covid.

AstraZeneca opted for a chimpanzee adenovirus, J&J for a human adenovirus. Other Covid adenovirus vector vaccines include Russia’s Sputnik V and China’s CanSino. Many European countries have continued to restrict the use of AstraZeneca, despite the EMA declaring it safe and saying blood clots are only a "very rare" side effect.

Meanwhile, Indian Prime Minister Narendra Modi late on Tuesday called on Indians to step up their efforts to battle the coronavirus so that fresh lockdowns are not necessary, as the vast nation reels from an explosion of cases and the capital runs dangerously short of oxygen supplies.

In his first address since the start of the record-breaking new wave of infections, Modi acknowledged that the nation of 1.3 billion people was "once again fighting a big fight". "The situation was under control till a few weeks back, and then this second corona wave came like a storm," the Indian leader told the nation in a televised speech.

"It is a big challenge but we have to -- together, with our courage and determination -- overcome it... We have to avoid lockdowns and we need to focus on mini containment zones instead."

India has been struggling to rein in its raging outbreak, with hospitals running out of beds and regional governments forced to reimpose economically painful restrictions. The South Asian nation has recorded more than three million new infections and 18,000 deaths this month, bringing its caseload to the world’s second-highest, after the United States.

Its capital and worst-hit city New Delhi entered a week-long lockdown on Monday, with parks, cinemas and malls closed. Maharashtra state, the epicentre of the recent surge and home to financial capital Mumbai, on Tuesday further tightened restrictions on grocery shops and home deliveries.

All non-essential shops and malls in the western state are currently shut until May 1. Uttar Pradesh, home to some 240 million people, on Tuesday announced a weekend lockdown from Friday evening, whilst Telangana state in the south became the latest to impose a night curfew.

Delhi Chief Minister Arvind Kejriwal, who on Tuesday went into self-isolation after his wife tested positive, called on the national government to supply the capital with oxygen amid a severe shortage.

"Some hospitals are left with just a few hours of oxygen," he tweeted late Tuesday. Delhi’s lockdown prompted tens of thousands of migrant workers to flee the mega-city, in scenes reminiscent of the national shutdown a year ago that inflicted economic and human misery.

Modi said states had to assure migrant workers of support and vaccines so that they would not return to their villages. "I appeal to states to avoid lockdowns and use them as a last resort," he added. The huge surge in infections saw the United States update its travel advisory for India, after the State Department announced it would apply "do not travel" guidance to about 80 percent of countries worldwide, citing the unprecedented risk posed by the pandemic.

"Even fully vaccinated travelers... should avoid all travel to India," the US Centers for Disease Control and Prevention said. Singapore also boosted restrictions on arrivals from India Tuesday, adding a week to the previously required 14-day quarantine period.

These moves follow Britain’s decision on Monday to add India to its "red list", and Hong Kong’s ban on all flights from the country. Meanwhile, Rahul Gandhi, a senior leader of the opposition Congress party and scion of the Nehru-Gandhi political dynasty, tweeted Tuesday that he had tested positive but had "mild symptoms", one day after former prime minister Manmohan Singh, 88, was admitted to hospital with the virus.

In a sign of how dangerously overstretched the hospitals are, people are using social media to appeal for medical supplies for their relatives.

On Monday night, a special "Oxygen Express" train left Mumbai to the industrial southern city of Visakhapatnam, carrying seven empty tanker trucks that should return full in four days. Modi added that "all efforts are being made" to boost oxygen supplies.

Experts have warned that religious festivals and packed state election rallies have become "superspreader" events -- and some have said mass vaccinations are the only long-term solution.

India kicked off its inoculation drive in mid-January and has administered more than 127 million shots so far. From May, all adults will be able to get vaccinated, the government announced Monday.

Some local authorities have however been running short of supplies, and India has put the brakes on exports of the AstraZeneca shot.

In a related development, the Dutch government said on Tuesday it will end its coronavirus curfew and allow cafes to serve outdoors during limited hours from April 28 as it relaxes pandemic restrictions.

The introduction of the nighttime curfew in January, the first in the Netherlands since World War II, sparked the country’s worst riots for decades. "We are of course glad that this is possible again because society yearns for more freedom," Prime Minister Mark Rutte told a press conference.

Rutte added that it was a "step that is very careful", as infections are still rising week on week as the country tries to step up its vaccination programme.

Cafes will be allowed to serve people on outdoor terraces between 12pm and 6pm, with a maximum of 50 people, said Rutte. People will also be allowed to have two guests at home per day, instead of the current limit of one person.