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Where are we in the Covid-19 vaccine race? – world news

US drugmaker Pfizer Inc and German partner BioNTech SE released final late-stage trial data on Wednesday that showed their shot was 95% effective at stopping Covid-19, the highest efficacy rate so far.The companies are the first to publish final Phase III efficacy and safety data and plan to apply for an emergency use authorization (EUA) in the United States within days.

Drugmakers and research centers around the world are working on Covid-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Here is everything you need to know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed more than 1.34 million lives worldwide:

Other than Pfizer, which companies are in the vaccine race?

On Monday, US pharmaceutical company, Moderna Inc, released interim data showing that its vaccine worked in a large, late-stage clinical trial with a 94.5% efficacy rate.

Interim late-stage trial results for Russia’s Sputnik V vaccine published on Nov. 11 showed the shot is 92% effective.

The next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

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What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of Covid-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

What were pharma companies waiting for to release data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data. Early in the trials, infection rates were low. With a surge in infections around the globe in October and November, trial participants became infected more quickly.

How well are the vaccines supposed to work?

The World Health Organization ideally wants to see at least 70% efficacy in trials. The US Food and Drug Administration wants at least 50% – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

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When will regulators rule on safety and efficacy?

Pfizer/BioNTech plan to submit an EUA application in US within days. Moderna aims to file an application in the coming weeks once it has the two months of safety data on half the trial participants, as required by the US Food and Drug Administration. That should happen in the second half of November. That means an FDA decision is unlikely before December. Regulators for Europe, the United Kingdom and Canada are considering data as it becomes available. It is not clear when companies will submit efficacy data or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four Chinese vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac Biotech.

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