AstraZeneca shot is shown to be effective.
LONDON— Drugmaker AstraZeneca said Monday that late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a relatively cheap, easy-to-store product that may become the vaccine of choice for the developing world.
The results are based on an interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine.
AstraZeneca is the third major drug company to report late-stage data for a potential COVID-19 vaccine as the world waits for scientific breakthroughs that will end a pandemic that has pummeled the world economy and led to 1.4 million deaths.
But unlike the others, the Oxford-AstraZeneca vaccine doesn’t have to be stored at freezer temperatures, making it potentially easier to distribute, especially in developing countries.
“I think these are really exciting results,” Dr. Andrew Pollard, chief investigator for the trial, said at a news conference. “Because the vaccine can be stored at fridge temperatures, it can be distributed around the world using the normal immunization distribution system. And so our goal ... [is] to make sure that we have a vaccine that was accessible everywhere. I think we’ve actually managed to do that.”
The Oxford-AstraZeneca vaccine was 90% effective in preventing COVID-19 in one of the dosing regimens tested; it was less effective in another. Earlier this month, rival drugmakers Pfizer and Moderna reported preliminary results from late-stage trials showing their vaccines were almost 95% effective.
While the AstraZeneca vaccine can be stored at 36 to 46 degrees, the Pfizer and Moderna products must be stored at freezer temperatures. In Pfizer’s case, it must be kept at the ultracold temperature of around minus-94 Fahrenheit.
The AstraZeneca vaccine is also cheaper.
AstraZeneca, which has pledged it won’t make a profit on the vaccine during the pandemic, has reached agreements with governments and international health organizations that put its cost at about $2.50 a dose. Pfizer’s vaccine costs about $20, while Moderna’s is $15 to $25, based on agreements the companies have struck to supply their vaccines to the U.S. government.
All three vaccines must be approved by regulators before they can be widely distributed.
Oxford researchers and AstraZeneca stressed they weren’t competing with other projects and said multiple vaccines would be needed to reach enough of the world’s population to end the pandemic.
The AstraZeneca trial looked at two different dosing regimens. A half-dose of the vaccine followed by a full dose at least one month later was 90% effective. Another approach, giving patients two full doses one month apart, was 62% effective.
That means that, overall, when both ways of dosing are considered, the vaccine showed an efficacy rate of 70%.
Sarah Gilbert, a leader of the Oxford team, said researchers aren’t sure why giving a halfdose followed by a larger dose was more effective, and they plan to investigate further. But the answer is probably related to providing exactly the right amount of vaccine to get the best response, she said.
The vaccine uses a weakened version of a common cold virus that is combined with genetic material for the characteristic spike protein of the virus that causes COVID-19. After vaccination, the spike protein primes the immune system to attack the virus if it later infects the body.
Peter Openshaw, professor of experimental medicine at Imperial College London, said the finding that a smaller initial dose is more effective than a larger one is good news because it may reduce costs and mean more people can be vaccinated with a given supply of the vaccine.
The results reported Monday come from trials in the U.K. and Brazil that involved 23,000 people. Of those, 11,636 people received the vaccine, while the rest got a placebo.
Overall, there were 131 cases of COVID-19. Details on how many people in the various groups became ill weren’t released Monday, but researchers said they will be published in the next 24 hours.
Late-stage trials of the vaccine are also underway in the U.S., Japan, Russia, South Africa, Kenya and Latin America, with further trials planned for other European and Asian countries.
Researchers said they expect to add the half dose-full dose regimen to the U.S. trial in a “matter of weeks.’’ Before doing so they must discuss the changes with the U.S. Food and Drug Administration.
The AstraZeneca trials were paused earlier this year after a participant in the U.K. study reported a rare neurological illness. While the trials were quickly restarted in most countries after investigators determined the condition wasn’t related to the vaccine, the FDA delayed the U.S. study for more than a month before it was allowed to resume.
AstraZeneca CEO Pascal Soriot said Monday that the Oxford vaccine’s simpler supply chain and AstraZeneca’s commitment to provide it on a nonprofit basis during the pandemic mean it will be affordable and available to people around the world. “This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact,’’ Soriot said.