AstraZeneca : Covid-19 Vaccine Wins EU Green Light -- 3rd Update

By Drew Hinshaw and Daniel Michaels

The European Union's drug regulator recommended use of a Covid-19 vaccine from AstraZeneca PLC, but the approval is unlikely to quell growing political furor over its effectiveness, production problems and availability.

Friday's announcement from the European Medicines Agency, endorsing the vaccine's use in people 18 and older, advances a shot that EU officials have considered critical in turning the tide of the pandemic in the region. But an EMA warning the shot hasn't been sufficiently tested in people over 55 adds to manufacturing woes dogging the project and prompted fresh attacks.

Some Europeans -- even high officials -- have interpreted the lack of data as meaning the vaccine is not effective.

"The real problem with AstraZeneca is that it hasn't worked the way we expected. Because we've had very little information," said French President Emmanuel Macron shortly before the EMA announcement.

The makers of the vaccine say they believe it to be effective in the elderly and that they expect further data from clinical trials to bear that out.

"We are confident that the vaccine will work across all age groups and we do not expect the final efficacy to be significantly different across different age groups," said a spokesman for the University of Oxford, which developed the vaccine with AstraZeneca.

The EMA said evidence of protection against serious illness outweighs the uncertainty, a position similar to the U.K.'s, which started administering the shot in early January to adults 18 years and older.

And while the vaccine's approval was welcomed in a region grappling with high levels of infections, thousands of deaths a day and extensive lockdowns, the news was tempered by problems in producing the two-dose shot and a growing battle with the EU over their contract.

The uncertainties mean Friday's decision might only slightly accelerate the EU's vaccine rollout, which has so far been slow. AstraZeneca's revelation in recent days that it will deliver less than one-third of its promised doses in the first quarter due to serious production challenges has sparked recriminations from EU officials and a war of words between them and the company.

EU frustration is compounded by its reliance on AstraZeneca, which accounts for more than 17% of the bloc's contracts for more than 2.3 billion vaccine doses from six providers. Almost half those contracted doses are for vaccines that are many weeks away from potential approval for use, and even further from widespread distribution.

As a result, EU countries are lagging many other leading economies in inoculations, raising pressure on politicians in national capitals and Brussels. The slow rollout in Europe and the prospect of continued lockdowns in much of the region bodes ill for the bloc's economy.

Figures due out next week could show that the eurozone economy contracted in the fourth quarter of last year, when countries imposed fresh restrictions. Now, a slow vaccination campaign and continued restrictions will likely further delay the recovery of the eurozone economy.

Globally, the timelines for vaccination campaigns have been slipping in many countries and have yet to get under way in much of the developing world, with negative implications for trade and travel. According to UBS, only about 11% of the world's population will be inoculated by the end of 2021 at the current pace, rising to 21% by the end of next year. Those figures could rise, however, if vaccination campaigns accelerate, according to the bank.

The EU has inoculated 2% of its total population, compared with about 6% in the U.S. and more than 10% in the U.K. The EMA authorized vaccines developed by Pfizer Inc. in December and that by Moderna Inc. earlier this month.

Aggravating the EU delays, Moderna has told non-U.S. countries that it will be delivering fewer doses than anticipated in February, a company spokeswoman said. The company blamed a slower-than-anticipated production ramp-up at Lonza Group, the Swiss contract manufacturer that is making the vaccine's active substance, a Moderna spokeswoman said. France's health ministry said it would be receiving 25% fewer doses in February than anticipated from Moderna.

Moderna said it would make up February's missed deliveries in March, allowing the company to meet its delivery commitments for the first quarter as a whole.

Moderna's production problems mirror those at AstraZeneca, which has slashed its delivery forecast because a contractor in Belgium has faced reported lower-than-expected output.

The EU bet big on AstraZeneca's shot, preordering up to 400 million doses, enough to inoculate nearly half of the region's 450 million people. The bloc had expected to receive at least 100 million doses -- and up to 120 million -- by the end of March. In December, the company said it would deliver just 80 million. Last week, AstraZeneca officials told EU leaders the bloc would receive as few as 31 million doses -- enough to vaccinate about 15 million people.

The shortfall sparked the spat with the EU, which on Friday published a redacted version of its contract with AstraZeneca to show it has been harmed. The bloc is prepping measures to block exports of vaccines or vital ingredients following reports that AstraZeneca had shipped vaccines produced in the EU to the U.K, which recently left the bloc. AstraZeneca has said it is working as quickly as possible to fix manufacturing issues and increase production so it can catch up on planned delivery schedules.

AstraZeneca's production problems come atop questions dogging the effectiveness of its vaccine. The company and Oxford recruited relatively few elderly test subjects during early stages of clinical trials, so those results have been slower to come through. The EMA wanted 7,500 people older than 65 or who had serious health conditions to partake in trials, but AstraZeneca and Oxford hasn't met that benchmark.

Germany's health ministry said Thursday it would recommend that only people 64 and younger receive the shot, saying there wasn't enough data on whether it worked in older demographics.

If other countries adopt the same approach, the shot might largely be used for younger adults in high-risk jobs, and will do little to slow the pace of deaths in people over 65, a demographic that accounts for about 90% of the more than 400,000 Covid-19-related deaths in the EU.

Oxford said Friday that its scientists and AstraZeneca continue to provide updated clinical-trial data to regulators. Oxford-run trials in the U.K. and Brazil that formed the basis of U.K. authorization of the vaccine in December had sparse data on trial volunteers over age 55. But additional data that is still coming in -- and includes more information from elderly trial volunteers -- could lead to amendments by European countries' recommendations that the shot be restricted to people 64 or younger. Such age-based restrictions could be updated if further data shows adequate safety and efficacy in the elderly, researchers say.

EU authorities are set within days to formally authorize the use of the shot following Friday's EMA approval. Distribution could begin days later, following administrative procedures needed to coordinate a rollout across 27 member states.

--Jenny Strasburg, Matthew Dalton and Stacy Meichtry contributed to this article.

Write to Drew Hinshaw at [e-mail] and Daniel Michaels at [e-mail]

(END) Dow Jones Newswires

01-29-21 1326ET