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Experts Break Down Clinical Considerations for a Complete Understanding of the COVID Vaccine

December 07, 2020

During a session at ASHP Midyear 2020, Litjen Tan, MS, PhD, chief strategy officer, Immunization Action Coalition, and Mary S Hayney, PharmD, MPH, professor of pharmacy, University of Wisconsin–Madison School of Pharmacy, provided details on clinical trial designs for COVID-19 vaccine candidates, outlined opportunities to address vaccine hesitancy, and discussed clinical implications related to COVID-19 vaccine(s) made available through Emergency Use Authorization.

Of important note, this session was originally recorded on November 17, 2020, and speaker points were further clarified in a live Q&A at the end of the recorded session.

Dr Tan kicked off the session by breaking down the differences between typical vaccine development versus that of the COVID-19 vaccine. He explained that typical vaccine development is done over 10-20 years. However, for the pandemic vaccine development, the timeframe target is 12-18 months. Compared with the standard development of up to 12 years, the development for the COVID-19 vaccine is up to 12 months.

According to Dr Tan, “Ensuring safety and effectiveness in healthy human participants is done in parallel, while maintaining trial size, quality, approval of regulatory trials, and ability to scale up. Incoming data can be used to modify the trial as it is ongoing.”

Dr Tan explained that during the regulatory review and approval process, which is 8-12 months, there is a continuous and early collaboration with federal agencies. This is to ensure a rapid and appropriate approval process.

He said that if there is a positive immune response, preliminary evidence of efficacy and an adequate safety profile are needed in order for authorization to be considered for early emergency use.

Of important note, although coverage will be available in both public and private markets, vaccine distribution is unique during a pandemic. It was explained during the session that federal response is done in coordination with state administered response.

In terms of manufacturing and distribution, Dr Tan explained that widespread manufacturing can be scaled up to commercial levels before clinical trials are completed. However, every vaccine batch created is still tested and re-tested to ensure the utmost quality and consistency between batches.

Once the vaccine is available, Dr Tan explained that there are many factors associated with low vaccination rates among adults. He noted that some patients would rather choose to deal with the side effects of a chronic condition than one related to a vaccine. He said that as the provider, your recommendation is important and can help address vaccine hesitancy. Additionally, he noted that vaccine confidence is not frequently identified as a barrier.

The CDC has recently announced a new strategy called, “Vaccinate with Confidence.” This program is designed to reinforce trust, empower health care providers, and engage communities and individuals.

The second half of the program was led by Mary S Hayney, PharmD, MPH. She spoke about herd immunity. She explained that herd immunity described immunization strategies and that no infection has ever achieved herd immunity.

Dr Hayney said that there is needs to be a community immunity level at 60% for immunization to herd immunity. It is to be assumed that roughly 10% have been infected and that the vaccine confers 70% protection.

Next in her presentation she talked a bout “Operation Warp Speed.” Being overseen by the Department of Health and Human Services as well as the Department of Defense, the goal is to produce 300 million doses of the COVID-19 vaccine by 2021. The protocols of this are being overseen by the federal government she noted, and there are no steps that are eliminated.

Dr Hayney went on to discuss how clinicians would handle the COVID vaccine if it is released with emergency use authorization (EUA). She said that that fact sheets would be given and there is a list of items clinicians should be aware of. Clinicians need to know that under an EUA extent benefits and risks of the vaccine are unknown; there is the option to accept or refuse administration; there may be known and potential benefits and risks of the vaccine; and consequences of refusing administration.

The current preliminary plan for this vaccine rollout is aimed at going to health care workers in Phase 1a, followed by essential workers, and those at high risk with medical conditions that are 65 years and older in Phase 1b.

Finally, Dr Hayney discussed vaccine record keeping. She said that vaccine data must be entered into Immunization Information Systems within 24 hours. Providers will develop a process to match the first and second doses among patients, and patients receiving the vaccine will receive a record card.

The final part of the session was a question-and-answer opportunity among Dr Tan, Dr Hayney and Anna Legreid Dopp, PharmD, who was the moderator of the session.

During the live Q&A, Dr Tan revealed that the FDA is expected to release the Phase 3 clinical data from the Pfizer vaccine trials on December 8, 2020.

They further clarified that since the recording of this session, long-term care residents were added to the Phase 1a rollout of the vaccine. Dr Hayney highlighted that this addition adds roughly 3 million people to the first phase.

Dr Dopp asked the speakers about the side effects of the COVID vaccine. She again mentioned the concept of more people willing to accept side effects for chronic disease versus vaccine side effects. She asked them to discuss what are some known side effects of the vaccine, and how can pharmacists and other clinicians prepare patients. Drs Tan and Hayney explained that common adverse events included header, fever, and injection site reaction.

Dr Tan gave an example and said although a patient may experience these side effects, it is essentially a good sign so that patient knows they did truly get the vaccine and that it is beginning to work. Dr Hayney suggested that patients not pre-treat with acetaminophen and ibuprofen to try and avoid the pain associated with the vaccination. She said that although no real data exists in adults, there are randomized clinical trials in children that show acetaminophen can actually lower antibody counts.

In addressing hesitancy, they stressed that the FDA would not consider a vaccine application until a 2-month period after the second dose of the vaccine was administered.  Further, when asked who should not receive the vaccine, they stressed that patients with an allergy to something in the vaccine should not receive it, as well as children, immunosuppressed patients, pregnant women, and lactating mothers—there is not a lot of data in these patient groups.

Importantly, they highlighted that the Pfizer vaccine amount decreased to 20.5 million doses that will be available at first, and the Moderna vaccine will come in roughly 20 million doses.

An audience member asked what if a patient doesn’t receive their second dose in the recommended period, how should that be addressed? Although the CDC is reviewing this, said Dr Tan, the vaccine regimen should not be restarted. The patient in question should receive the second dose, they said.

They ended the session by saying this vaccine distribution has to be done globally. They stressed that a global pandemic cannot be controlled if vaccine are being distributed in one country. They said that they expect more companies to have developed vaccine options by the spring of 2021.

Julie Gould

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