NEW YORK (Reuters) – Drugmakers and research centers around the world are working on the COVID-19 vaccine, which includes large global trials of several candidates in which thousands of participants are participating well. Some companies suggested that initial test figures could be ready for release in October, but were subsequently pushed back to November and December.
The following is what we know about the race to deliver vaccines to help end the coronavirus epidemic that claimed more than one million lives worldwide:
US drugmaker Pfizer Inc., and US Biotech Modern Inc., along with German partner BioNotech SE, may have the initial data in November. UK-based AstraZeneca plc, in conjunction with the University of Oxford, and Johnson & Johnson say they are on track to deliver data for their vaccines this year.
What happens in these tests?
Companies are testing their vaccines against saline solutions, usually against placebo in healthy volunteers – to see if the rate of COVID-19 infection among those receiving the vaccine is significantly lower than those receiving dummy shots.
Why are data reports delayed beyond the original forecast?
The tests depend on subjects being naturally infected with the coronovirus, so how long it takes to produce results depends largely on where the viruses are being tested. Each drug manufacturer has targeted a specific number of infections to trigger the first analysis of its data.
For example, Pfizer believes that if its vaccine works after contracting COVID-19 in 44,000 people tested, it may be known that the majority of infected people had received placebo.
But drugmakers have recently slowed their ability to present earlier figures given the insufficient number of infections preceding spikes. In October, Pfizer said usable test data was not expected until the end of November due to slower infection rates. It previously suggested that would be in October.
AstraZeneca said a slowdown in infection during the summer delayed UK trials and expected results by the end of the year. Its time period was also halted to examine the disease in a UK trial participant.
Following the slow pace of infection in late summer and early autumn, COVID-19 cases underwent massive changes again in October and early November, setting a daily record as the weather cooled in the United States and Europe and People went inside the house. Experts have suggested that test participants may have to take more precautions to avoid contracting COVID-19 than normal participants, as they are aware that they may have gained a spot.
How will we know if the vaccine will work?
The United States, the European Union, the United Kingdom, and the World Health Organization have all set the same standards for effectiveness. Some regulators have stated that the vaccine should exhibit at least 50% efficacy – at least twice as many infections among volunteers who received a placebo among those in the vaccine group. The European Medical Agency has stated that it may accept a lower efficacy level.
When will the regulators decide?
Regulators will review vaccines after companies have sufficient data to submit an application to obtain an Emergency Use Authority (EUA) or formal approval. The first decision they can make in December is because Modern and Pfizer / BioNotech are not expected to have enough security data until the latter part of November. US regulators have asked that participants be seen for side effects for two months after receiving the last vaccine dose. AstraZeneca can provide a look at late stage data by the end of the year. UK officials said that there was some possibility that they might decide on the vaccine in late December.
Regulators for Europe, the United Kingdom and Canada are considering the data on a rolling basis, as it is available. They expect to quickly review preliminary data for potential emergency use before more traditional lengthy reviews for formal commercial approval.
Could these be the first approved coronavirus vaccines?
Yes, although China and Russia are on a similar timeline. China launched an emergency-use program in July aimed at requiring workers and others at high risk of infection that has vaccinated hundreds of thousands of people. There are at least four vaccines, including China’s National Biotech Group (CNBG), CanSino Biologics and Sinacac. Synovac and CNBG expect early test data in early November. Russia’s Gamalaya Institute has begun a late-stage trial of 40,000 people and is expected to have its initial figures in November. Russia has also vaccinated at least hundreds of “high-risk” members of the general population.
Reporting by Carl O’Donnell in New York; Additional reporting by Julie Stenhuysen in Chicago, Michael Erman in New York, Ludwig Berger in Frankfurt, Alistair Smort in London and Polina Ivanovo in Moscow; Editing by Caroline Humer and Bill Burcott