By Danica Kirka and Jill Lawless, The Associated Press November 23, 2020.
FILE – In this file photo from Wednesday, June 24, 2020, a volunteer receives an injection at Chris Hani Baragwanath Hospital in Soweto, Johannesburg, as part of Africa’s first participation in a COVID-19 vaccine trial being developed at the University of Oxford in Great Britain Britain in partnership with the pharmaceutical company AstraZeneca. On Friday, October 23, 2020, AstraZeneca Inc. Announced that the Food and Drug Administration is giving its approval to resume testing of its COVID-19 vaccine candidate in the US (Siphiwe Sibeko / Pool via AP)LONDON – Pharmaceutical company AstraZeneca said on Monday that late-stage studies have shown the coronavirus vaccine to be up to 90% effective, leaving public health officials hoping they will soon have access to a vaccine that is cheaper and easier to distribute than some of its rivals.
The results are based on interim analysis of trials in the UK and Brazil with a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or serious cases of COVID-19 were reported in those who received the vaccine.
AstraZeneca is the third major pharmaceutical company to report late-stage results for a possible COVID-19 vaccine as the world anxiously awaits scientific breakthroughs that will end a pandemic that wreaked economic havoc and led to nearly 1 4 million confirmed deaths.
Pfizer and Moderna reported preliminary results of late-stage studies last week, showing their vaccines were nearly 95% effective. But unlike its rivals, the AstraZeneca vaccine does not need to be stored at ultra-cold temperatures, making it easier to distribute, especially in developing countries.
“I think these results are really exciting,” ?? Dr. Andrew Pollard, the trial’s lead investigator, said at a news conference. “Because the vaccine can be stored at refrigerator temperatures, it can be distributed all over the world through the normal immunization distribution system. And so our goal “¦ to make sure we have a vaccine that was accessible everywhere, I think we could really do that.” ??
The Oxford-AstraZeneca vaccine is also cheaper. AstraZeneca, which has pledged not to profit from the vaccine during the pandemic, has entered into agreements with governments and international health organizations that put its cost at approximately $ 2.50 per dose. Pfizer’s vaccine costs about $ 20 per dose, while Moderna’s is $ 15 to $ 25, based on agreements the companies have made 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 that they are not competing with other projects and that multiple vaccines will be needed to reach enough of the world’s population and end the pandemic.
“We don’t think of vaccinations that work in terms of one person at a time. We need to think about vaccinating communities and populations, reducing transmission within those populations, so we really get on top of this pandemic, ”said Sarah Gilbert, a leader of the Oxford research team. “And so it now looks like we will have the opportunity to contribute in a very big way.”
The results come as a second wave of COVID-19 strikes many countries, once again closing businesses, limiting social interaction and hitting the global economy.
AstraZeneca said it will immediately request early approval of the vaccine whenever possible, and will request an emergency list from the World Health Organization so that the vaccine can be made available in low-income countries.
The AstraZeneca study looked at two different dosing regimens. Half a dose of the vaccine followed by a full dose at least one month later was 90% effective. Another approach, in which patients received two full doses one month apart, was 62% effective. The combined results showed an average efficacy rate of 70%.
The vaccine uses an attenuated version of a cold virus that combines with genetic material for the virus’s characteristic spike protein that causes COVID-19. After vaccination, the spike protein stimulates the immune system to attack the virus if it later infects the body.
The vaccine can be transported under “normal refrigerated conditions” ?? from 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), AstraZeneca said. In comparison, Pfizer plans to distribute its vaccine using specially designed “thermal shippers” ?? that use dry ice to maintain temperatures of -70 degrees Celsius (minus-94 degrees Fahrenheit).
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, as it can cut costs and vaccinate more people.
“The report that a first half dose is better than a full dose seems counterintuitive to those of us who view vaccines as normal drugs: with drugs we expect higher doses to have greater effects and more side effects”? he said. “But that’s not how the immune system works.” ??
The results reported Monday come from studies in the UK and Brazil involving 23,000 people. Late-stage trials are also underway in the US, Japan, Russia, South Africa, Kenya and Latin America, with further trials planned for other European and Asian countries.
AstraZeneca has ramped up manufacturing capacity so that it can deliver hundreds of millions of doses of the vaccine from January, Chief Executive Pascal Soriot said earlier this month.
Soriot said on Monday that the simpler supply chain of the Oxford vaccine and AstraZeneca’s commitment to deliver it on a nonprofit basis during the pandemic means it will be affordable and available to people around the world.
“The efficacy and safety of this vaccine confirm that it will be highly effective against COVID-19 and have an immediate impact on this public health emergency,” said Soriot.
British Health Secretary Matt Hancock said he felt “a great sense of relief”? on the news from AstraZeneca.
Britain has ordered 100 million doses of the Oxford vaccine, and the government says several million doses could be produced before the end of the year if approved by regulators.
Just months ago, “the idea that we would have three vaccines by November, all of which are of high effectiveness” ¦ I would have given my eye teeth, “Hancock said.
___
Follow AP’s reporting at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak
Source link