EU regulators give nod to AstraZeneca COVID vaccine for emergency use

The European Medicines Agency (EMA) today recommended the AstraZeneca-Oxford vaccine for emergency use in European Union (EU) countries, which came with more details about efficacy, which is about 60%, with the vaccine showing good impact against severe disease.

The approval shed more light on findings from phase 3 clinical trials in the United Kingdom, Brazil, and South Africa and comes amid a row between EU officials and the company over supply contracts, which followed an announcement from the company that its supply would be less than expected.

Questions on efficacy in seniors, against variant

The United Kingdom was the first country to green light the AstraZeneca-Oxford vaccine, clearing it for emergency use on Dec 30 based on interim clinical trial findings.

In an announcement today, the EMA said combined results from four clinical trials that involved about 24,000 people suggested that the vaccine was safe and effective at preventing COVID-19 infections in those ages 18 and older. However, it said it based its efficacy assessment on results from studies in the United Kingdom and Brazil, because the others—including one in South Africa—had fewer than six cases, which wasn't enough to measure the vaccine's protective effect.

Along with the 60% efficacy noted by the EMA, the company said today there were no severe cases or hospitalizations more than 14 days after the second dose. An earlier interim estimate at the time when the United Kingdom cleared the vaccine for emergency use put effectiveness at 70.4%.

Results from South Africa are eagerly awaited, in light of news this week that two other vaccines soon to enter the market, the ones from Novavax and Johnson & Johnson, were less effective against the B1.351 variant first seen in South Africa. Earlier this month, UK officials said they expected more information in the coming weeks from the South African trials on how well the vaccine works against the B1.351 variant.

Some countries, including Germany, have raised concerns about the vaccine's efficacy in seniors, and the EMA said that most study participants were between ages 18 and 55 years old, with not enough people over age 55 to provide an efficacy finding in the older age groups. However, the EMA said it expects that the vaccine will protect seniors, since they showed an immune response that has also been seen with other vaccines. "More information is expected from ongoing studies, which include a higher proportion of elderly participants," it said.

AstraZeneca today said in a statement that the viral-vector vaccine is administered as two doses, 4 to 12 weeks apart, and is well-tolerated with no serious safety events. The vaccine can be stored at standard refrigeration temperatures for up at least 6 months. 

The vaccine has been granted emergency use in 20 countries across 4 continents so far, and the company is conducting a large trial in the United States and other parts of the world, with a goal of enrolling up to 60,000 people.

Tensions over AstraZeneca vaccine order

Today's approval came on the same day that a clash between EU officials and AstraZeneca came to a head over reduced vaccine supply projections, with the European Commission today announcing export measures, which it says are aimed at making vaccine delivery information more transparent.

The clash came after AstraZeneca announced last week that there were problems at one of its EU factories and that it expects a 60% supply shortfall, according to the BBC. The EU has insisted that AstraZeneca honor its advance purchase agreements by shifting doses made in the UK, but AstraZeneca said its contract for UK supply prohibits it from doing so until it fills Britain's order.

At a World Health Organization (WHO) briefing today, health officials spoke out against "vaccine nationalism" and warned of the consequences of not sharing vaccine across the world equitably. When asked about the vaccine row in Europe, Director-General Tedros Adhanom Ghebreyesus, PhD, repeated the WHO's advice that all countries should ensure that healthcare workers and those at highest risk are prioritized across the globe to receive the first vaccine supplies.

He warned that not sharing vaccine will result in a catastrophic moral failure, keep the pandemic burning, and lead to a very slow economic recovery. "This is a small world now, and we need to help one another."

Other global headlines

  • Bolivia's doctors are calling for a national lockdown, amid a COVID-19 surge that has hospitals near their breaking points and is killing about one health worker a day, according to Reuters.

  • Vietnam, which recently reported the first reappearance of the virus in about 2 months, today reported 53 new cases, including one in Hanoi, the South China Morning Post reported. Among the latest cases, 47 were found in Hai Duong province, the main hot spot.

  • Other countries are tightening their restrictions to slow the spread of the virus, including the Philippines, which extended a partial lockdown for Manila until the end of February, and the United Arab Emirates, which continues to report more single-day case totals.

  • The global total today climbed to 101,803,875 cases with 2,198,644 deaths, according to the Johns Hopkins online dashboard.

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