What to watch for next in the race for the coronavirus vaccine

The coming weeks represent a critical time in the race for the coronavirus vaccine. This is because a vaccine may soon be allowed to be used. Pfizer (NYSE: PFE) recently became the first vaccine developer to seek emergency use authorization (EUA) from the United States Food and Drug Administration (FDA). And four other programs in the United States and Europe follow closely behind.

The pace of this race picks up as it approaches the finish line. So, for investors hoping to identify short-term winners, it is important to monitor the situation closely. Here’s what to watch out for next.

Image source: Getty Images.

Modern

Modern (NASDAQ: ARNM) has led this race from the start. In March, the biotech company became the first to launch an experimental vaccine against the coronavirus in human trials. Since then, the program has progressed smoothly, with a late trial starting in July. Last week Moderna announced positive data from this trial. It involved more than 30,000 participants who received either Moderna’s vaccine candidate or a placebo. The first interim analysis showed a vaccine efficacy of 94.5%. The analysis was based on the development of 95 cases of COVID-19. Only five of these confirmed cases belonged to the vaccinated group and the others to the placebo group. Eleven of the COVID-19 cases were serious – and all occurred in the group that received the placebo.

The company also said the vaccine did not pose any safety concerns. This is a critical point for regulatory authorization. But Moderna has to wait a few more days to apply. The FDA requires two months of safety data tracking before considering a candidate for EUA. Moderna CEO Stephane Bancel said earlier that the requirement would be met from November 25. So, later this week, we might expect news of a request for EUA from this CEO.

AstraZeneca

The next few days may also bring a regulatory submission of AstraZeneca (NASDAQ: AZN). The large pharmaceutical company announced data from phase 3 trials of its experimental vaccine on Monday morning.

AstraZeneca has studied its vaccine using two dosing schedules. Both involved two doses of the vaccine. The dosing regimen with half a dose followed by a full dose one month later produced the best result, with 90% efficacy. The other, two full doses given one month apart, showed 62% effectiveness. Of those who received the vaccine, none developed a serious case of COVID-19. This analysis looked at 131 cases of coronavirus. The trial includes more than 23,000 participants who received one of two dosing regimens or a placebo.

While AstraZeneca’s efficiency results have so far not been as strong as those of their rivals Moderna or Pfizer, that doesn’t mean it has lost its chance at EUA. There is a global need for a vaccine, so regulators are likely to authorize multiple vaccines – provided the efficacy and safety meet certain thresholds. The FDA says it expects at least 50% effectiveness from a coronavirus vaccine candidate. This means that AstraZeneca and others have achieved this goal and that safety guidelines are on the right track.

AstraZeneca says it “will now immediately prepare for regulatory submission” in all countries that offer emergency clearances.

Pfizer

As mentioned above, Pfizer has already applied for an EUA after announcing the test results earlier this month. The company’s vaccine candidate showed 95% effectiveness in a trial involving more than 43,000 participants. The analysis included 170 cases of COVID-19. Of these, 162 occurred in participants who received the placebo and eight in those who received the investigational vaccine. Nine of 10 severe cases of COVID-19 were in the placebo group; one was in the vaccinated group.

So what’s next for Pfizer? The FDA has scheduled a meeting on December 10 to discuss the company’s results with its Advisory Committee on Vaccines and Related Biologics (VRBPAC). The FDA does not have to follow the VRBPAC recommendations. But he seriously weighs the conclusions of this panel of experts before making a decision. The FDA has not specified how long its review will take, but government officials are aiming for year-end marketing. Operation Warp Speed ​​chief scientific adviser Dr Moncef Slaoui told CNN the government could start shipping a vaccine as early as December 11.

What does this mean for investors?

Short-term equity gains could be on the horizon for all three companies – if the FDA grants them EUAs. But I wouldn’t expect a dramatic stock market gain from Pfizer or AstraZeneca. Given their wide range of products on the market, these large pharmaceutical companies will not depend on the potential COVID-19 vaccine for their revenue.

In the final stages of this race Moderna should benefit the most. The biotech company has no other products on the market yet, so investors’ hopes rest on the coronavirus vaccine candidate. A win here could offer a big advantage now and in the future as income begins to rise.