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LONDON – Pharmaceutical AstraZeneca said on Monday late-stage trials showed its Covid-19 vaccine to be highly effective, raising the prospects for a relatively cheap and easy-to-store product that may become the world’s preferred vaccine in developing.
The results are based on an interim analysis of trials in the UK and Brazil of a vaccine developed by the University of Oxford and manufactured by AstraZeneca. There were no reported hospitalizations or serious cases of Covid-19 in those who received the vaccine.
AstraZeneca is the third major pharmaceutical company to report late-stage data for a potential Covid-19 vaccine as the world awaits scientific breakthroughs that will end a pandemic that has hit the global economy and caused 1.4 million deaths. But unlike the others, the Oxford-AstraZeneca vaccine does not have to be stored at freezing temperatures, which makes it potentially easier to distribute, especially in developing countries.
“I think these are really exciting results,” said Dr. Andrew Pollard, the trial’s lead investigator, at a news conference. “Because the vaccine can be stored at refrigerator temperature, it can be distributed around the world using the normal immunization delivery system. And so our goal … to make sure we have a vaccine that is accessible everywhere, I think we’ve really done it. “
The Oxford-AstraZeneca vaccine was 90 percent effective in preventing Covid-19 in one of the dosing regimens tested; it was less effective in another. Earlier this month, rival drug makers Pfizer and Moderna reported preliminary results from late-stage trials that showed their vaccines were nearly 95 percent effective.
While AstraZeneca vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), Pfizer and Moderna products must be stored at freezing temperatures. In Pfizer’s case, it should be kept at an ultra-cold temperature of around minus -70 degrees Celsius (minus -94 Fahrenheit).
The AstraZeneca vaccine is also cheaper.
AstraZeneca, which has promised that it will make no profit from the vaccine during the pandemic, has reached agreements with governments and international health organizations that estimate its cost at around $ 2.50 per dose. Pfizer’s vaccine costs about $ 20, while Moderna’s costs between $ 15 and $ 25, depending on agreements the companies have reached to supply their vaccines to the US government.
All three vaccines must be approved by regulators before they can be widely distributed.
The Oxford and AstraZeneca researchers emphasized that they were not competing with other projects, saying that multiple vaccines would be needed to reach enough of the world’s population to end the pandemic.
“We need to be able to make a lot of vaccines for the world quickly, and it’s better if we can do it with different technologies, so if one technology runs into an obstacle, then we have alternatives, we have diversity. ” Professor Sarah Gilbert, leader of the Oxford team, told The Associated Press. “Diversity is going to be good here, but also in terms of manufacturing, we don’t want to run out of raw materials.”
AstraZeneca said it will immediately apply for early approval of the vaccine when possible, and will seek an emergency use list from the World Health Organization, to make the vaccine available in low-income countries.
The AstraZeneca trial looked at two different dosing regimens. A half dose of the vaccine followed by a full dose at least a month later was 90 percent effective. Another approach, giving patients two full doses one month apart, was 62 percent effective.
That means that overall, when both dosage forms are considered, the vaccine showed a 70 percent efficacy rate.
Gilbert said the researchers are not sure why giving a half dose followed by a larger dose was more effective and plan to investigate further. But the answer is likely related to providing exactly the correct amount of vaccine to get the best answer, he said.
“I think it’s the amount of Goldilocks you want, not too little and not too much. Too much could also give you a shoddy response … ” he said. “I’m glad we looked at more than one dose because it turns out to be really important.”
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 prepares 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 starting dose is more effective than a larger one is good news because it can lower costs and mean more people can get vaccinated with a determined supply of vaccine.
“The report that a starting half dose is better than a full dose seems contradictory to those of us who think of vaccines as normal drugs – with drugs, we expect higher doses to have greater effects and more side effects,” he said. . “But the immune system doesn’t work like that.”
The results reported Monday come from trials in the UK and Brazil involving 23,000 people. Of them, 11,636 people received the vaccine, while the rest received a placebo.
Overall, there were 131 cases of Covid-19. Details on how many people in the various groups became ill were not released Monday, but the researchers said they will be released within the next 24 hours.
Late-stage trials of the vaccine are also underway in the US, Japan, Russia, South Africa, Kenya, and Latin America, with additional trials planned for other European and Asian countries.
The researchers said they hope to add the full-dose half-dose regimen to the US trial in “a matter of weeks.” Before doing so, they should discuss the changes with the U.S. Food and Drug Administration.
The AstraZeneca trials were stopped earlier this year after a study participant from the UK reported a rare neurological disease. While trials were quickly restarted in most countries after researchers determined the condition was not related to the vaccine, the FDA delayed the US study for more than a month before it was allowed to resume. .
AstraZeneca has been increasing manufacturing capacity, so it can supply hundreds of millions of doses of the vaccine starting in January, CEO Pascal Soriot said earlier this month.
Soriot said Monday that Oxford’s simpler vaccine supply chain and AstraZeneca’s commitment to providing it on a non-profit basis during the pandemic mean it will be affordable and available to people around the world.
“The efficacy and safety of this vaccine confirm that it will be very effective against Covid-19 and will have an immediate impact on this public health emergency,” Soriot said.
British Health Secretary Matt Hancock said he felt “a great sense of relief” at the AstraZeneca news.
Britain has ordered 100 million doses of the vaccine and the government says several million doses can be produced before the end of the year if regulators approve it.
Just a few months ago, “the idea that by November we would have three vaccines, all of which are highly effective … I would have given up,” Hancock said.
Since the beginning of their collaboration with AstraZeneca, Oxford scientists have demanded that the vaccine be equitably available to everyone in the world so that rich countries cannot corner the market as has happened during previous pandemics.
The leaders of the world’s most powerful nations agreed on Sunday to work together to ensure “affordable and equitable access” to Covid-19 drugs, tests and vaccines.
“If we don’t have the vaccine available in many, many countries, and we only protect a small number of them, then we cannot get back to normal because the virus will keep coming back and causing problems again,” Gilbert said. “No one is safe until we are all safe.” AP
