Since the beginning of the COVID-19 pandemic, high hopes have been placed on the potential for a vaccine. The U.S. government established Operation Warp Speed, a program with the goal of accelerating the development of safe and effective novel coronavirus vaccines. Biopharmaceutical companies both large and small shifted resources to focus on COVID-19 vaccine research.
Today, these efforts are closer to paying off than ever before. But what's the real state of the coronavirus vaccine race? Here are seven key things you'll want to know.
1. Who the leaders are right now
There are currently 180 COVID-19 vaccine programs in development, according to the World Health Organization (WHO). Thirty-five of those vaccine candidates are being evaluated in clinical studies with the rest in preclinical testing. Nine of the 35 clinical-stage COVID-19 vaccine candidates are in late-stage testing.
Chinese drugmakers Cansino Biologics, Sinopharm, and Sinovac Biotech are developing four of the late-stage coronavirus vaccine candidates. Russia is already allowing a COVID-19 vaccine developed by Moscow's Gamaleya Research Institute of Epidemiology and Microbiology to be administered to some individuals, although the vaccine is still in late-state testing.
There are four late-stage COVID-19 vaccine candidates targeting the U.S. market:
- Pfizer (NYSE:PFE) partnered with BioNTech (NASDAQ:BNTX) to develop BNT162b2, a vaccine that uses modified messenger RNA (mRNA) to spur the body to produce antibodies to the novel coronavirus SARS-CoV-2.
- Moderna (NASDAQ:MRNA) is also developing an mRNA vaccine candidate, mRNA-1273.
- AstraZeneca (NASDAQ:AZN) teamed up with the University of Oxford to develop AZD1222, which delivers genetic material from the SARS-CoV-2 spike protein using a weakened version of the adenovirus (a common cold virus).
- Johnson & Johnson (NYSE:JNJ) is starting its late-stage testing of Ad26.COV2.S this month.
2. When a vaccine will likely be available
There's no way to be completely sure when a COVID-19 vaccine will be available. It's possible that problems could arise in clinical studies. For example, AstraZeneca recently paused its late-stage clinical trial of AZD1222 due to a serious adverse reaction in a participant.
However, the chances appear to be reasonably good that a coronavirus vaccine will receive FDA emergency use authorization (EUA) before the end of 2020. Pfizer and BioNTech expect to seek authorization for BNT162b2 in October if late-stage testing goes well. AstraZeneca and Moderna might not lag too far behind.
It's possible that there will be a phased roll-out of early COVID-19 vaccines. One potential scenario would be for healthcare workers and high-risk individuals to receive the vaccine first, followed by the rest of the population.
3. How safe and effective the vaccines will be
We won't know how safe and effective individual COVID-19 vaccines will be until they've completed late-stage testing. However, to secure an EUA the FDA must determine that the benefits of the vaccine outweigh the risks. The agency has stated that it will review "the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product" before granting an EUA.
To win full FDA approval, a COVID-19 vaccine will have to demonstrate at least 50% efficacy in a placebo-controlled clinical study. It will also need to meet the general safety requirements for previously approved vaccines for infectious diseases.
4. How many doses will be required
Most of the coronavirus vaccines in late-stage testing require two doses, typically administered four weeks apart. Johnson & Johnson's investigational COVID-19 vaccine, however, requires only one dose.
5. How much a coronavirus vaccine will cost
Coronavirus vaccines will be provided to all Americans at no cost. Healthcare providers, though, could charge insurers for the cost of administering the vaccines.
6. Which vaccines could be in the second wave
Three COVID-19 vaccines are currently in phase 2 clinical testing, according to the WHO. These include vaccines developed by Novavax (NASDAQ:NVAX), German biotech CureVac (NASDAQ:CVAC), and Chinese drugmaker Anhui Zhifei Longcom. Inovio Pharmaceuticals (NASDAQ:INO) is awaiting FDA approval to begin phase 2 testing of its coronavirus vaccine candidate as well.
7. Which stocks are poised to win the most
Any of the stocks of companies that win FDA EUA or approval for their respective COVID-19 vaccines will likely perform well. However, the smaller biotech stocks would almost certainly enjoy bigger gains than the big pharma stocks. This could mean that BioNTech and Moderna could be the biggest winners among the leaders in the coronavirus vaccine race.
Keep in mind, though, that there's still a risk that the vaccine candidates will stumble in clinical testing. The safer stocks to buy, therefore, will be those of large drugmakers such as AstraZeneca and Pfizer since the companies have enough product diversification to withstand a setback in their COVID-19 vaccine programs.