Light at the End of the Tunnel: Latest on the Coronavirus Vaccine

There has been an ambitious drive to develop a COVID-19 vaccine at lightning speed. However, this goal seems to be unrealistic. Americans will need to reset their expectations about how quickly they are going to be vaccinated.

President Donald Trump said the U.S. government could start distributing a coronavirus vaccine as early as October, a much more optimistic estimate than his own health officials have publicly advised.

“We’re very close to that vaccine as you know and I think much closer than I think most people want to say,” Trump said during a White House press briefing on September 16. “We think we can start sometime in October. So as soon as it’s announced we’ll be able to start. That will be from mid-October on. It may be a little bit later than that.”

The U.S. Food and Drug Administration (FDA) may not authorize a COVID-19 vaccine until January 2021 at the earliest, according to Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases—but that is not stopping drug manufacturers from producing them by the millions ahead of time.

As of right now, there are a number of companies racing to be the first across the vaccine finish line. Those leading the charge are in a Phase 3 trial stage. According to the New York Times, in Phase 3 trials, scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus. In June, the F.D.A. advised vaccine makers that they would want to see evidence that vaccines can protect at least 50 percent of those who receive it. In addition, Phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.

Amongst the pack is AstraZeneca Plc. The U.K. drugmaker is poised to unveil their coronavirus shot that could be ready for large-scale vaccinations as early as this year, Chief Executive Officer Pascal Soriot said, dismissing reports of delays and production snags. AstraZeneca stopped administering new doses of its vaccine on Sept. 6, a step first reported by STAT, after a participant in the trial developed severe symptoms. These symptoms were reportedly caused by transverse myelitis, a serious spinal cord condition.

Another contender for developing the virus is Johnson & Johnson. They have developed vaccines for Ebola and other diseases, and have now made one for the coronavirus. In March they received $456 million from the United States government to support their move towards production. The vaccine has provided protection in experiments on monkeys. On Oct. 11, Johnson & Johnson had to pause their testing after a participant in the trial developed neurological symptoms. According to a person familiar with the matter, a male volunteer in his twenties had a cerebral hemorrhage and transverse sinus venous thrombosis. The Washington Post, citing two sources, said this case was a stroke. Unlike other vaccines in Phase 3 trials, Johnson & Johnson’s only requires one dose instead of two

Between the two other vaccine frontrunners, Moderna, and Pfizer, they emphasized that the U.S. should have access to at least 50 million vaccine doses by the end of 2020. Assuming each American needs two doses of the vaccine for maximum immunity, that is enough to vaccinate 25 million people–less than 10% of the population. However, until the FDA gives the go-ahead, those doses will have to stay in storage.

The United States government has invested in both companies to ensure quick and easy access to their products if proved safe and effective. They provided nearly $2 billion to Pfizer through Operation Warp Speed and nearly $1 billion to Moderna through multiple investments through the Biomedical Advanced Research and Development Authority. Both companies are wrapping up their late-stage clinical trials, but have yet to release information regarding the safety of their vaccines.

It is unclear who will be first in line to receive the vaccine once approved–which should be within 24 hours of the FDA’s green light. Those who work in healthcare, and those who are at higher risk, such as the elderly, are likely to have initial access. There is still uncertainty on how long it will be until a vaccine is authorized by the FDA, and whether the first round of immunizations will be safe or not.