US authorizes Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use

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A pharmacist prepares to give a Johnson & Johnson experimental, single-shot COVID-19 vaccine in this September 2020 photo. (Johnson & Johnson via AP, File)
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Vials of Johnson & Johnson's Janssen COVID-19 vaccine candidate are seen in an undated photograph. (Johnson & Johnson/Handout via REUTERS)
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Updated 28 February 2021
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US authorizes Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use

  • The J&J vaccine is the third to be greenlighted in the US after Pfizer’s and Moderna’s were provisionally approved in December
  • US President Joe Biden hails 'exciting news' but urge Americans not to let guard down

WASHINGTON: The United States on Saturday authorized Johnson & Johnson’s Covid vaccine for emergency use, giving the nation a third shot to battle the outbreak that has killed more than 500,000 Americans.
The single-shot vaccine is highly effective in preventing severe Covid-19, including against newer variants, the Food and Drug Administration (FDA) said before giving it a green light.
“This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis,” US President Joe Biden said in a statement.
But he urged Americans to remain vigilant with anti-virus curbs such as social distancing, warning that new variants of the virus still posed a threat.
“But we cannot let our guard down now or assume that victory is inevitable,” he said.
A third vaccine is seen as a vital means to ramp up the immunization rate in the United States, where more than 500,000 people have lost their lives to the coronavirus.
In large clinical trials, the J&J vaccine’s efficacy against severe disease was 85.9 percent in the United States, 81.7 percent in South Africa, and 87.6 percent in Brazil.
Overall, among 39,321 participants across all regions, the efficacy against severe Covid-19 was 85.4 percent, but it fell to 66.1 percent when including moderate forms of the disease.
Crucially, analyses of various demographic groups revealed no marked differences across age, race, or people with underlying conditions.
The J&J vaccine is the third to be greenlighted in the United States after Pfizer’s and Moderna’s were provisionally approved in December.

Practical advantages
Over 65 million people in America have so far received at least one shot of either the Pfizer or Moderna vaccines — but unlike those, the J&J vaccine requires just one dose, and is stored at fridge temperatures, offering logistical and practical advantages.
The J&J shot appears less protective than Pfizer and Moderna’s two-shot regimens, which both have an efficacy of around 95 percent against all forms of Covid-19 from the classic coronavirus strain.
All three have been shown to fully protect against hospitalizations and death, however.
Nirav Shah, director of the Maine Center for Disease Control and Prevention, told The Washington Post the two earlier vaccines were tested months before the emergence of “variants of concern” that could affect the efficacy, meaning the Pfizer and Moderna results were not an “apples to apples” comparison with the J&J shot.
There was a hint, based on preliminary data, that the J&J vaccine might be effective against asymptomatic infection — though the company said it needs to do more research.
The company has announced it aims to deliver 20 million doses by the end of March, with 100 million by June — though the US is pushing to expedite that timeline.
The J&J vaccine uses a common-cold causing adenovirus, which has been genetically modified so that it can’t replicate, to carry the gene for a key protein of the coronavirus into human cells.


EU leaders work into the night to ease Belgian fears of Russian retaliation over a loan to Ukraine

Updated 58 min 32 sec ago
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EU leaders work into the night to ease Belgian fears of Russian retaliation over a loan to Ukraine

BRUSSELS: European Union leaders worked into the night on Thursday, seeking to reassure Belgium that they would provide guarantees to protect it from Russian retaliation if it backs a massive loan for Ukraine. Ukraine’s Volodymyr Zelensky meanwhile pleaded for a quick decision to keep Ukraine afloat in the new year.
At a summit in Brussels with high stakes for both the EU and Ukraine, leaders of the 27-nation bloc discussed how best to use tens of billions of euros in frozen Russian assets to underwrite a loan to meet Ukraine’s military and financial needs over the next two years.
The bulk of the assets — some 193 billion euros  as of September — are held in the Brussels-based financial clearing house Euroclear. Russia’s Central Bank launched a lawsuit against Euroclear last week.
“Give me a parachute and we’ll all jump together,” Belgian Prime Minister Bart De Wever told lawmakers ahead of the summit. “If we have confidence in the parachute that shouldn’t be a problem.”
Belgian concerns over Russian pressure
Belgium fears that Russia will strike back and wants the bloc to borrow the money on international markets. It says frozen assets held in other European countries should be thrown into the pot as well, and that its partners should guarantee that Euroclear will have the funds it needs should it come under legal attack.
An estimated 25 billion euros  in Russian assets are frozen in banks and financial institutions in other EU countries, including France, Germany and Luxembourg.
The Russian Central Bank’s lawsuit ramped up pressure on Belgium and its EU partners ahead of the summit.
The “reparations loan” plan would see the EU lend 90 billion euros  to Ukraine. Countries like the United Kingdom, which said Thursday it is prepared to share the risk, as well as Canada and Norway would help make up any shortfall.
Russia’s claim to the assets would still stand, but the assets would remain locked away at least until the Kremlin ends its war on Ukraine and pays for the massive damage it caused.
In mapping out the loan plan, the European Commission set up safeguards to protect Belgium, but De Wever remained unconvinced and EU envoys were working late on Thursday to address his concerns.
Zelensky describes it as a moral question

Soon after arriving in Brussels, the Ukrainian president sat down with the Belgian prime minister to make his case for freeing up the frozen funds. The war-ravaged country is at risk of bankruptcy and needs new money by spring.
“Ukraine has the right to this money because Russia is destroying us, and to use these assets against these attacks is absolutely just,” Zelensky told a news conference.
In an appeal to Belgian citizens who share their leader’s worries about retaliation, Zelensky said: “One can fear certain legal steps in courts from the Russian Federation, but it’s not as scary as when Russia is at your borders.”
“So while Ukraine is defending Europe, you must help Ukraine,” he said.
Allies maintain support for Ukraine
Whatever method they use, the leaders have pledged to meet most of Ukraine’s needs in 2026 and 2027. The International Monetary Fund estimates that would amount to 137 billion euros .
“We have to find a solution today,” European Commission President Ursula von der Leyen told reporters. EU Council President António Costa, who is chairing the meeting, vowed to keep leaders negotiating until an agreement is reached, even if it takes days.
Polish Prime Minister Donald Tusk said it was a case of sending “either money today or blood tomorrow” to help Ukraine.
If enough countries object, the plan could be blocked. There is no majority support for a plan B of raising the funds on international markets, although that too was being discussed at the summit.
German Chancellor Friedrich Merz said that he hopes Belgium’s concerns can be addressed.
“The reactions of the Russian president in recent hours show how necessary this is. In my view, this is indeed the only option. We are basically faced with the choice of using European debt or Russian assets for Ukraine, and my opinion is clear: We must use the Russian assets.”
Hungary and Slovakia oppose a reparations loan. Apart from Belgium, Bulgaria, Italy and Malta are also undecided.
“I would not like a European Union in war,” said Hungarian Prime Minister Viktor Orbán, who sees himself as a peacemaker. He’s also Russian President Vladimir Putin’s closest ally in Europe. “To give money means war.”
Orbán described the loan plan as a “dead end.”
High stakes for the EU

The outcome of the summit has significant ramifications for Europe’s place in negotiations to end the war. The United States wants assurances that the Europeans are intent on supporting Ukraine financially and backing it militarily — even as negotiations to end the war drag on without substantial results.
The loan plan in particular also poses important challenges to the way the bloc goes about its business. Should a two-thirds majority of EU leaders decide to impose the scheme on Belgium, which has most to lose, the impact on decision-making in Europe would be profound.
The EU depends on consensus, and finding voting majorities and avoiding vetoes in the future could become infinitely more complex if one of the EU’s founding members is forced to weather an attack on its interests by its very own partners.
De Wever too must weigh whether the cost of holding out against a majority is worth the hit his government’s credibility would take in Europe.
Whatever is decided, the process does not end at this summit. Legal experts would have to convert any political deal into a workable agreement, and some national parliaments may have to weigh in before the loan money could start flowing to Ukraine.