A health worker prepares a syringe with Covishield, the Oxford / AstraZeneca vaccine made in India.
ERIKA SANTELICES / AFP through Getty Images
It has been a bumpy road for a new Covid-19 vaccine developed by pharma giant AstraZeneca and Oxford University. On Feb. 15, the vaccine received Emergency Use List designation from the World Health Organization, allowing it to begin distribution in low- and middle-income countries. In January, the vaccine was approved for use in the European Union, following a December 30 decision by the UK to approve the vaccine. But despite its recent gains, the vaccine is still in limbo in the U.S. where there are no concrete plans for emergency approval, despite the desperate need for more Covid-19 vaccines.
The wait has angered many pundits on social media, who are demanding immediate approval for the AstraZeneca vaccine. “I think we should agree to AstraZeneca [people] fo 45 ASAP, ” wrote Derek Thompson, author at Atlantic, “Expanding the supply of vax would save lives, and the benefits outweigh the risks. ”
Matthew Yglesias, a writer on Substack who previously worked at Vox write: “Despite the botched clinical trial, there seems to be no doubt that the WHO-approved Oxford / AstraZeneca vaccine is working.”
So why hasn’t the FDA approved it yet? The main reason is simple: the company has not yet applied for an emergency use permit. The process must be initiated by the company – regulators cannot roll the ball themselves.
In the US there are a number of factors holding back the AstraZeneca / Oxford vaccine, says Andrew Berens, an analyst at SVB Leerink. “I think a big part of the reason it hasn’t received EUA in the U.S. yet is because the FDA wants to see a U.S. lawsuit going on,” he said. Berens estimates that the test data will be available sometime in the first half of this year. A spokesman for the company said this data would be available in the “coming weeks,” but would not provide a more accurate timeline.
The AstraZeneca vaccine is different from the two vaccines currently authorized for use in the US, created by Moderna and Pfizer / BioNTech. Both of these vaccines use mRNA technology, which makes cells inside the body secrete fragments of the virus that stimulate the immune system. The AstraZeneca vaccine works by using a modified version of the virus for the common cold that affects chimpanzees. This virus acts as a delivery service that delivers DNA into patient cells. This DNA directs the cell to convert it to mRNA, which programs cells to produce fragments of the virus that stimulate an immune response. This immune response then prepares the body to attack the Covid-19 virus if a person becomes infected.
Clinical trials have shown that the vaccine is 82% effective in preventing the most common form of SARS-CoV-2 after two doses, but is much less effective in protecting against some of the other variables currently in circulation. Like the Pfizer and Moderna vaccines, it is extremely effective against serious illness, hospitalization and death – no – one who has received the AstraZeneca vaccine to date has died from Covid – 19. And because of the toughness of the vaccine, it can be stored in a conventional refrigerator instead of the ultra-cold temperature required by both mRNA vaccines.
Despite these benefits, clinical trials for the AstraZeneca vaccine were implemented with initiation and discontinuation. Last fall, all phase three clinical trials of the vaccine were stopped abruptly after a UK patient showed signs of a severe brain disorder called transverse myelitis. After a 45-day halt, the trial began in the U.S., but the delay left AstraZeneca more than a month behind its competitors.
The stopwatch is not the only hurdle that the AstraZeneca vaccine has revealed. South Africa had widely spread the vaccine, but a recent study, which was not peer-reviewed, said the vaccine was largely ineffective in preventing it. the 501Y.V2 version which has been widely circulated in that country. On February 10, South Africa announced it would stop using the AstraZeneca vaccine and instead switch to using the Covid-19 vaccine made by Johnson & Johnson. It is reported that the country is now asking the Indian manufacturer of the vaccine to recover a million doses of the vaccine. Also this month, European Commission regulators attacked one of the company’s vaccine manufacturing sites in Belgium after the company’s production problems said only half of the promised doses would be delivered to the EU this quarter.
Berens says manufacturing capability will be one of the key factors the FDA looks at when deciding whether to approve the vaccine. “Manufacturing is very difficult for vaccines,” he said, “it’s complicated, and the bar is very high.” It is not yet known where US vaccine doses will be made.
All of these problems have affected the company’s progress in the vaccine race, putting it behind Pfizer, Moderna and Johnson & Johnson, and until it has advanced level 3 data from U.S. clinical trials AstraZeneca will not claim EUA into the FDA. As soon as AstraZeneca is involved, experts at the organization will review all the vaccine data in a process that will take several weeks and will involve public committee hearings. Only after everything has been finalized could another Covid-19 vaccine be available in the US