Regardless of race, religion or socioeconomic status, one thing most, if not all, Americans can agree on is that we are tired of the pandemic and the economic, health and political fallout we have collectively experienced from it.
And while there may be disagreement about the best way to approach the pandemic, it is generally held that a safe, effective COVID-19 vaccine that can be manufactured and distributed at scale is a critical step toward economic recovery.
Even for people within the life science and health care industries, it has been increasingly difficult to keep up with the pace of scientific developments, policy positions, and political rhetoric around a potential vaccine. Below, we break down some of the latest news and developments around the vaccine candidates and where they stand.
Who’s driving and where are we going?
Scientists have been working at a blistering pace to shorten the vaccine development cycle from years to months in order to get a COVID-19 vaccine to market. With more than 190 such vaccines in development, there are several leading the pack. Here’s the latest on these efforts, as of Oct. 15:
- There are 11 vaccines globally that are either in Phase 3 clinical trials, or have received emergency authorization in a limited number of countries to administer vaccines to specific groups, such as health care workers.
- There are four vaccines in Phase 3 trials for use in adults over 18 in the United States. The companies developing those four vaccines are AstraZeneca, Johnson & Johnson, Moderna and Pfizer.
- AstraZeneca’s vaccine trial has been on hold in the United States since Sept. 8 due to an unexplained illness identified in the United Kingdom arm of its clinical trial. The study has since resumed in the U.K. but not in the United States.
- On Oct. 12, Pfizer received approval from the Food and Drug Administration to enroll children age 12 and older in its clinical trial. Pfizer is the first and only vaccine developer in the United States to be testing a COVID-19 vaccine on children. This is seen as a critical step in protecting the entire population and supporting a return to school, not just a return to work.
- No vaccine candidates have been submitted to the FDA for emergency use authorization (EUA).
What has to happen for a vaccine to be approved?
- Within the FDA’s four-phase drug approval process, Phase 3 trials consist of many thousands of patients, a portion of which get the vaccine candidate and a portion of which receive a placebo (each referred to as “arms” of the study).
- Those patients are monitored over time with the intent of assessing the safety and efficacy of the vaccine.
- Scientists and regulators determine safety through the occurrence of any adverse side effects. They determine efficacy based on the proportion of infections between the placebo and vaccine arms of the trial. In general, the number of positive cases necessary to assess efficacy is between 50 and 100.
- Researchers accumulate and assess the results, and then determine if there is sufficient data to submit the vaccine to the FDA for approval. In the case of a COVID-19 vaccine, the drug companies are expected to apply for an EUA so they can start emergency distribution during the pandemic while they continue with the study to assess long-term safety and efficacy.
That last step of receiving emergency use authorization has been the main political flash point in recent months.
Clarity from the FDA
In guidance published in early October by the FDA on EUA applications for COVID-19 vaccines, the agency advised vaccine developers to report clinical data within a median two-month period after the last vaccination treatment in their trial has been administered. Given the time frame for when most Phase 3 trials began, this means it is likely that companies will not be able to submit the data required for EUA until after the Nov. 3 election.
The White House initially pushed back against the guidance, “worried that the criteria would delay authorization of a vaccine, presumably beyond the Nov. 3 election,” but ultimately approved the standards, the Washington Post reported.
The agency also said that an FDA advisory board responsible for reviewing and evaluating vaccines for approval will hold an Oct. 22 session that will cover only general matters such as what level of efficacy should be required for approval and how they will evaluate safety. No specific vaccines or EUAs will be discussed, the agency said.
The issue garnering the most attention is the FDA’s suggestion about how much data vaccine developers will need to present and over what period of time. In practical terms, the FDA is suggesting that trial participants be monitored for an average of two months after their last injection. Under some basic assumptions that a trial had relatively consistent recruitment over time, and that the median approximates the mean or average, if a company wanted to submit data on Oct. 30, then roughly half of the participants would have needed to receive their last injection by Aug. 30.
We also know that most Phase 3 trials were not announced until July or August, and that two of the primary vaccine candidates require two injections, spaced 28 days apart. This means results probably will not be submitted to for EUA until November or December at the earliest.
Messaging from the vaccine developers
We believe it is important to put rhetoric aside and focus on the actual communications from leaders of the major players in the development and review of these critical vaccine candidates. Here is some of what these executives have said:
- “I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” – Pfizer Chairman and CEO Albert Bourla, in an open letter to U.S. colleagues, Oct. 1.
- “Nov. 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA.” – Moderna CEO Stephane Bancel at a Financial Times conference, Sept. 30.
- On Sept. 23, Johnson & Johnson became the latest vaccine developer to begin Phase 3 trials. Chief Scientific Officer Dr. Paul Stoffels said the company might be able to determine by the end of the year if the vaccine is safe and effective. On Oct. 12, the company announced it would be pausing its trial due to “an unexplained illness in a study participant.” While not unusual in studies of this type, it does extend the completion date for the trial.
- “The one learning message that we came to … was to recommend to the companies that we are supporting [through Operation Warp Speed] that if they achieve efficacy demonstration [of their vaccine] while there are no vaccine doses available at industrial scale … to be able to immunize at least a relevant fraction of the population, that they should refrain or at least consider refraining for filing for an EUA,” Dr. Moncef Slaoui, scientific head of the federal government’s Operation Warp Speed, at a vaccine symposium hosted by Johns Hopkins University and the University of Washington on Oct. 6.
What does this all mean?
To sum it up:
- There are four vaccines in late-stage U.S. trials. Two of those are paused, and the other two are likely to apply for EUA by the end of the year.
- The scientific community and regulatory agencies are committed to proving the safety and efficacy of any vaccine, as well as a company’s ability to manufacture sufficient quantities for distribution to the most at-risk portions of the population.
- The recent pause of multiple clinical trials for both vaccines and therapies is a sign that the monitoring and review processes are working.
- The federal government is working with state governments to develop detailed plans for the distribution of vaccines as they become available. These groups are tackling questions of how to prioritize doses across different groups, the logistics of distributing vaccines throughout the country, and planning for how to vaccinate millions of residents.
- Even if approval is not granted until sometime in 2021, it still would be the fastest vaccine development cycle ever, and there are multiple vaccines that could receive authorization.
That last point should not be undervalued, as it is truly amazing how quickly the global scientific community has reacted to the pandemic. As devastating and tragic as this pandemic is, our life science professionals are proving that they can rise to the challenge through their work on therapies, testing kits, medical equipment, personal protective equipment, and other supplies that have been crucial in supporting the health and safety of the community. A vaccine, whenever it is finalized, would only add to that list of accomplishments.
