European regulator sees “no urgent need” for COVID-19 boosters, aligning with WHO, not US point of view



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The European Medicines Agency said on Thursday there was no “urgent need” for COVID-19 booster vaccines for fully vaccinated people and suggested instead that the focus should remain on primary vaccination and get vaccines in the arms of one in three adults in Europe. Union who are still not vaccinated.

The news, made in a statement, offers a regulator’s latest position on the issue, which sparked controversy among public health experts in the United States after President Joe Biden said last month Americans would start. to receive reminders from September 20. This has sparked fears that the White House will overtake science and data on vaccine recalls.

To learn more about the booster debate: COVID-19 vaccine booster shots are more complicated than they appear. Here’s why.

The EMA statement aligns with the World Health Organization’s view on boosters: that none should be offered by developed countries while the rest of the world is still hampered by a supply shortage after richer countries claimed most of the first available shots.

WHO Director-General Tedros Adhanom Ghebreyesus called on August 4 for a moratorium on recalls to ensure that the poorest countries have access to first doses. The agency said there was still not enough data to show that boosters are needed for people who have received both injections of a two-dose vaccine to curb the spread of the virus.

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WHO has been pushing for vaccines to be distributed to 10% of the population in all countries by September, arguing that since entire swathes of a population go unvaccinated, variants can emerge, with the risk that one of them will prove to be totally resistant to the vaccine.

On Wednesday, the WHO said it had identified a new “variant of interest” called B.1.621 and assigned it the Greek letter mu. At this time, more studies are needed to assess its ability to resist vaccines that have been authorized or approved for use around the world.

Don’t miss: WHO identifies new ‘variant of interest’ of coronavirus, experts urge caution on boosters

A number of countries are already giving boosters to some of their vaccinated populations, including Israel, Germany and France. The UK has pledged to give them to people with severely weakened immune systems and at high risk of serious illness, but has yet to decide on the remaining population. These injections are considered third injections and are part of the primary vaccination course.

The EMA’s statement makes it clear that it would also classify injections for immunocompromised people as part of the primary vaccination course.

“Evidence of vaccine effectiveness and duration of protection shows that all vaccines authorized in the EU / EEA are currently highly protective against hospitalizations, serious illness and death from COVID-19,” says the EMA press release.

The Biden administration has announced that Americans who have been fully vaccinated with a two-dose regimen against Covid-19 should be given a booster, citing the threat of the highly contagious Delta variant. WSJ breaks down what you need to know. Photo: Hannah Beier / Reuters

ARNM from Moderna Inc.,
+1.98%,
meanwhile, submitted its recall data to the FDA on Wednesday evening. BioNTech BNTX,
-1.19%
and Pfizer PFE,
+ 1.74%
said last week that they had submitted data for their booster injection to the FDA. These data looked at antibody levels in adults who received a third dose between four and eight months after the initial vaccination.

There was promising news in a study published Wednesday in the medical journal The Lancet, which found that the risk of long-term COVID drops by almost half after a person receives two doses of a vaccine.

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

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

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

In the United States, the vaccination program, which has gained momentum in recent weeks as more employers mandate the vaccination of workers returning to resumed offices and schools, continued to advance. The Centers for Disease Control and Prevention tracker shows 174.6 million people are now fully vaccinated, or 52.6% of the total population. This means that they had two injections of vaccine from Pfizer and its German partner BioNTech or one developed by Moderna, or one injection of JNJ from Johnson & Johnson,
+ 0.68%
single dose vaccine.

Of American adults 18 years and older, 63.6% are completely inoculated and 74.4% have received at least one dose.

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

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

See: Joe Rogan Says He Has COVID-19, Took ‘Kitchen Sink’ Treatment Approach – Including Ivermectin

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

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

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

See now: The EU recommends restrictions on Americans due to the rise in COVID. Read this before traveling to Europe

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The global tally of coronavirus-transmitted diseases topped 218.6 million on Thursday, while the death toll rose to 4.54 million, according to data aggregated by Johns Hopkins University.

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

India has the second-highest death toll after the United States at 439,529 and is third per case with 32.9 million, according to data from Johns Hopkins.

Brazil has the second highest death toll with 581,150 and has recorded 20.8 million cases.

In Europe, Russia recorded 181,560 deaths, followed by the United Kingdom with 133,066.

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

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