As we go to press this month, more than 200 vaccines for COVID-19 are under development around the world. In the U.S., multiple companies are working to create a vaccine, with hopes for a safe and effective solution by the end of the year.
We spoke with Sandra Adamson Fryhofer, MD, MACP, an internal medicine physician, adjunct associate professor of medicine at Emory University School of Medicine and an American Medical Association (AMA) trustee. She also serves as the AMA liaison to the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) and is the AMA’s representative on ACIP’s COVID-19 vaccine workgroup. Here, Dr. Fryhofer shares her thoughts on how vaccine development is progressing.
Multiple Approaches Target a Common Enemy
“Things are moving fast in the COVID-19 vaccine environment due to the Department of Health and Human Service’s Operation Warp Speed (OWS). The OWS goal is to produce and deliver 300 million doses of COVID vaccines with the initial doses ready to deliver by January 2021, maybe even sooner,” Fryhofer says.
The first step in vaccine creation is preclinical testing on animals for baseline safety and efficacy. If success is determined in the preclinical stage, the testing moves on to three clinical trial phases. Phase 1 involves testing small groups of 20-100 people, with phase 2 including several hundred volunteers and Phase 3 adding thousands of participants.
“The later trials have to be large in order to reveal side effects that may have been missed in the earlier smaller studies,” she says. “Once Phase 3 is complete, the next step is gaining FDA approval and licensing.” However, the FDA may make a COVID-19 vaccine available before full licensing through the Emergency Use Authorization (EUA) process.
There are four major platforms currently in use on the COVID vaccine development landscape. Dr. Fryhofer breaks them down as follows:
- Live attenuated and inactivated virus vaccines.
None of the OWS-Supported COVID-19 vaccines are using this platform.
- Viral vector vaccines, either replicating or non-replicating.
Examples include AstraZeneca Oxford candidate vaccine AZD 1222 and Janssen’s (the pharmaceutical arm
of Johnson & Johnson) Ad26.COV2.S (previously known as AD26COVS1).
- Protein-based recombinant vaccines.
Examples include Novavax’s NVX-CoV 2372.
- Nucleic acid vaccines.
Examples include Moderna’s mRNA-1273 and Pfizer and BioNTech’s BNT162. A big challenge for mRNA
vaccines is their need to be stored at ultra-cold temperatures – a capability that most physicians
don’t have in their offices.
COVID Vaccine Planning
While the creation of a reliable COVID vaccine is certainly on the horizon, it is still a fluid situation, making it difficult for physicians to know what information to share right now with their patients. Fryhofer says it’s important for physicians to have trust in the system, which requires transparency in the vaccine creation process.
“Physicians are a trusted source of information for their patients. But in order for physicians to want to take the vaccine themselves and to feel confident in recommending it to patients, we must have trust in the process that created the vaccine,” she says. “Transparency goes a long way toward creating trust.”
Fryhofer adds that while preparing for the eventuality of a reliable COVID vaccine, physicians should keep in mind that flu season is underway.
“We still need to encourage people to get vaccinated for flu,” she says. “We will be right in the midst of the flu season and fighting COVID at the same time, setting the stage for a potential twindemic.”
It is likely that there will be more than one approved COVID vaccine coming onto the market, due to the number of platforms being used in product development. However, Fryhofer warns that safety and efficacy cannot be sacrificed even in a public emergency.
“All of this is happening in real-time, and it’s being rushed. You can think of it as a rush job, or you can think of it as happening quickly to address an emergency. And it’s a good thing there are multiple vaccines under study because some likely won’t pan out,” she says.
“There are bumps in the road. There are challenges and concerns about delivery and storage of the vaccines. We still have many information gaps; we need to know if some vaccines work better for certain populations than others, whether there are risks for older or younger patients, and whether some vaccines will require multiple doses or just one,” she adds. “If two doses are needed, we have to make sure the second dose matches the first dose. We have to think about documentation and careful record-keeping, which will be important in order to be successful.”
Fryhofer encourages physicians to learn about and understand the differences between the vaccines.
“As doctors, we have to dot our I’s and cross our T’s, know we can trust the process and understand what we’re recommending,” she says. “Because we are the ones our patients turn when it comes to their health.”
While we await an approved vaccine, Fryhofer stresses that the best way to avoid contracting or spreading the virus is to prevent exposure.
“As Dr. Anthony Fauci pointed out in a recent JAMA Viewpoint, we must not forget the power of low-tech interventions: hand hygiene, masks, distancing and avoiding congregate settings,” she says. “We need all the help we can get to regain some degree of normalcy.”