Oxford COVID-19 Vaccine May Be Ready for September, Remdesivir on Track for EUA Approval

Two hopeful advances in both the prevention and treatment of COVID-19 have been announced, with researchers at Oxford University making rapid headway in their development of a vaccine candidate, and a study conducted by the National Institute of Allergy and Infectious Diseases showing promising results for a treatment for existing coronavirus cases.

Researchers at Oxford are confident that a vaccine they’re developing for use against COVID-19 will be ready for production by September, to the point that India’s Serum Institute, the world’s largest vaccine producer, plans to begin production of the agent before the vaccine’s clinical trials are complete. The company estimates that they can produce 60 million doses by the end of the year, with another 400 million that could be produced over the course of 2021, if the vaccine succeeds.

Phase one clinical testing of the vaccine candidate in humans, called ChAdOx1 nCoV-19, has just begun, having previously shown to be effective in preventing six rhesus macaque monkeys from contracting the SARS-CoV-2 virus. The technique used to develop the vaccine involved injecting genetic material from the SARS-CoV-2 virus into a rhinovirus—the virus that would ordinarily cause the common cold, albeit one that has been genetically neutralized so that it can’t spread. This strange combination produces a safe mimic of the coronavirus that provides the body’s immune system with a blueprint of the pathogen, so that it knows how to deal with SARS-CoV-2 if an infection occurs.

Although the vaccine candidate has only entered phase one of its clinical trials, Serum Institute owner Cyrus Poonawalla feels that the risk of mass-producing the vaccine is worth it, and he has confidence in the Oxford team’s efforts. “They are a bunch of very qualified, great scientists [at Oxford] … That’s why we said we will go with this and that’s why we are confident,” according to Poonawalla.

Although a vaccine designed to provide immunity to COVID-19 might still be months away, there are patients in dire need of a treatment for their current infection; to that end, numerous organizations are testing myriad existing antiviral compounds in an attempt to find something that will save lives in the present. On April 29, the National Institute of Allergy and Infectious Diseases (NIAID) announced promising preliminary results in their studies on the drug known as remdesivir.

Developed as a treatment for the disease caused by the Ebola virus by Gilead Sciences, remdesivir (rem-DES-i-vir) is what is known as a nucleotide analog that tricks the virus into inserting the drug into its RNA code, interrupting the virus’s ability to replicate. The drug was deployed as one of the tools used in the fight against the West African Ebola virus epidemic of 2013–2016, and the 2018 Kivu Ebola epidemic.

Although it has yet to receive approval for general use in COVID-19 patients, preliminary results from NIAID show that remdesivir was able to reduce the average recovery time in advanced cases of the disease from 15 days down to 11. It also appears to improve survival rates, with mortality cut to 8 percent in the test patients, versus 11.6 percent in the placebo group.

“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is very important proof of concept,” explains NIAID director Dr. Anthony Fauci. “What it has proven is that a drug can block this virus. This development has prompted the FDA to announce plans to approve emergency-use authorization for remdesivir, for use in severe cases of COVID-19, the same approval previously granted for hydroxychloroquine.

Both of these promising developments come with a caveat, however: the studies of both the Oxford vaccine and remdesivir’s use for COVID-19 patients are still in their early stages, meaning that new developments later in their trials could exclude the drugs for reasons of either safety or efficacy—or possibly both.

The WHO has also pointed out that a single study will not guarantee the approved use of a drug, as multiple perspectives are required, and that the agency typically draws on evidence from several studies before reviewing and critiquing the findings.

“Typically, you don’t have one study that will come out that will be a game changer,” explains the WHO’s technical lead for the coronavirus response Dr. Maria Van Kerkhove.

“It can sometimes take a number of publications to determine (what) the ultimate impact of a drug is,” adds Dr. Mike Ryan, executive director of the WHO’s health emergencies program.