European regulator sees ‘no urgent need’ for COVID-19 boosters, aligning with WHO view and not the U.S. – MarketWatch

The European Medicines Agency said Thursday that there is no urgent need for COVID-19 booster shots for fully vaccinated people and suggested instead the emphasis should remain on primary vaccination and getting shots into the arms of the one out of three adults in the European Union who are still not inoculated.

The news, made in a statement, offers the latest stance from a regulator on the issue, which has stirred controversy among public health experts in the U.S. after President Joe Biden said last month that Americans would start getting boosters from Sept. 20. That sparked concerns that the White House was getting ahead of the science and data on vaccine boosters.

For more on the booster debate: COVID-19 vaccine booster shots are more complicated than they appear. Heres why.

The EMAs statement aligns with the World Health Organizations view on boosters: namely, that none should be offered by developed countries while the rest of the world is still hampered by a shortage of supply after wealthier countries laid claim to most of the earliest available shots.

WHO Director-General Tedros Adhanom Ghebreyesus called for a moratorium on boosters on Aug. 4 to ensure poorer countries get access to first doses.The agency has said there is still not sufficient data to show that boosters are needed by people who have had both shots of a two-dose vaccine in reining in the spread of the virus.

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The WHO has pushed to get vaccines to 10% of the populations of all countries by September, arguing that as major swaths of a population are unvaccinated, variants may emerge, with the risk that one might prove fully vaccine-resistant.

On Wednesday, the WHO said it had identified a new variant of interestcalled B.1.621, and assigned the Greek letter mu. For now, further studies are needed to evaluate its ability to resist the vaccines that have been authorized or approved for use around the world.

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A number of countries are already giving boosters to some of their vaccinated populations, including Israel, Germany and France. The U.K. has pledged to give them to people with severely weakened immune systems who are at high risk of severe illness, but it has not yet decided on the remaining population. Those shots are considered to be third shots and part of primary vaccination.

The EMAs statement makes clear that it would also classify shots for the immunocompromised as part of primary vaccination.

Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorized in the EU/EEA are currently highly protective against COVID-19-related hospitalization, severe disease and death, said the EMA statement.

Moderna Inc. MRNA, +1.46%, meanwhile, submitted its booster data to the FDA late Wednesday. BioNTech BNTX, -1.45% and Pfizer PFE, +0.81% said last week thatthey had submitted datafor their booster shot to the FDA. That data examined antibody levels in adults who got a third dose between four and eight months after initial vaccination.

There was promising news in a study published on Wednesday in the medical journal the Lancet, which found that the risk of so-called long COVID drops nearly in half after a person receives two doses of a vaccine.

Researchers found that the odds of having symptoms for 28 days or more after post-vaccination infection were approximately halved by having two vaccine doses.

The study also found almost all symptoms were less common in vaccinated people, that more people in the vaccinated than in the unvaccinated groups were completely asymptomatic and that COVID-19 was less severe (both in terms of the number of symptoms in the first week of infection and the need for hospitalization) in participants after their first or second vaccine doses compared with unvaccinated participants.

The study was based on 1.2 million people who used a COVID symptoms app in the U.K.

In the U.S., the vaccine program, which has gained some traction in recent weeks as more employers mandate vaccination for workers returning to offices and schools return to session, continued to edge up. The Centers for Disease Control and Preventions tracker is showing that 174.6 million people are now fully vaccinated, equal to 52.6% of the overall population. That means they have had two shots of Pfizer and German partner BioNTechs vaccine or of the one developed by Moderna, or one shot of Johnson & Johnsons JNJ, +0.56% single-dose vaccine.

Among U.S. adults 18 and older, 63.6% are fully inoculated and 74.4% have received at least one dose.

But cases, hospitalizations and deaths continue to climb to their highest levels since winter as the delta variant shows no sign of slowing its spread. A New York Times tracker is showing that hospitalizations remain above 100,000 a day on average and average daily deaths are at 1,418.

Since the start of August, the number of daily deaths has more than quadrupled and most are among unvaccinated people.

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Elsewhere, Bulgaria is tightening restrictions to combat the spread of the virus and will close restaurants and bars at 10 p.m. from Sept. 7 and host indoor sports without spectators, the Guardian reported. Bulgaria has the lowest vaccination rate in the EU, according to Reuters, at just 16.7% of its population, and the highest mortality rate, losing some 18,950 people to COVID since the start of the outbreak.

India recorded 47,092 new COVID cases on Thursday, to mark the biggest one-day tally in two months, India Today.com reported. The last time cases were higher than this was 63 days ago, on July 1, when India reported 48,786 cases. On Wednesday, 41,965 COVID-19 cases were recorded.

Hawaii is struggling to transport tanks of oxygen from the mainland as it grapples with a surge of COVID cases, the New York Times reported. Medical officials are asking Hawaiians to postpone elective surgeries as intensive-care-unit beds are being used for COVID patients. The seven-day hospitalization average peaked at 427 on Monday, driven by the delta variant and a relatively low vaccination rate.

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The global tally for the coronavirus-borne illness climbed above 218.6 million on Thursday, while the death toll rose to 4.54 million, according todata aggregated by Johns Hopkins University.

The U.S. leads the world with a total of 39.4 million cases and 642,096 deaths.

India has the second highest death toll after the U.S. at 439,529 and is third by cases at 32.9 million, the Johns Hopkins data shows.

Brazil has second highest death toll at 581,150 and has had 20.8 million cases.

In Europe, Russia has recorded 181,560 deaths, followed by the U.K. with 133,066.

China,where the virus was first discovered late in 2019,has had 107,102 confirmed cases and 4,848 deaths, according to its official numbers, which are widely held to be massively underreported.

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European regulator sees 'no urgent need' for COVID-19 boosters, aligning with WHO view and not the U.S. - MarketWatch