Vax Facts: Interview with a COVID-19 Vaccine Reviewer

In episode 46, we interviewed Sally’s mom, who is a reviewer for one of the COVID-19 vaccines, and discussed what she shared. Here is a brief transcript of the interview — check out the episode for the full details!

  1. Can you describe your daily work reviewing this vaccine? To get licensure in the US market, you need abundant information about manufacturing. You also need animal studies and a clinical study to support that the vaccine is effective and safe. For the clinical studies, it’s normally 3 phases — 1. which dosage will be effective and safety data for a smaller population (100 people or less), 2. Recruiting several hundred people to further confirm results, 3. A lot more people to support safety and efficacy. For the COVID vaccine, they recruited 40–50 thousand people to look for the efficacy of the vaccine and to find as much safety data as possible.
  2. When did you hear about the first SARS-COV2 vaccines being developed? The news was in China in November 2019. More cases were in the US by January and February. Companies and academia started doing research around March or April. I’m not sure about the exact time, but that was around when they started working on it.
  3. What was the review process like as people working on the safety of the vaccine? Safety is the utmost important thing. In the US, there’s a group of people who don’t like vaccinations. So we don’t want to destroy the credit of vaccines, we want people to trust vaccines and vaccinate themselves to create herd immunity to protect the whole community. The two COVID vaccines are currently available under EUA — EUA is emergency use authorization, which is different from the traditional licensing process. It doesn’t mean it’s not safe or it’s not adequately reviewed. Usually there’s a risk benefit approach to make an assessment. We’re confident that the information we have, based on the expertise of regulatory agents, the vaccine is safe and ready to be used. Even though the process is not completely done for approval of the vaccine, the public can use it to control the pandemic.
  4. How far into the clinical phase trials do the companies have to be to do the review process? The whole process is very dynamic. If a manufacturer has an idea to develop the vaccine, they will have a pre-investigative new drug (IND) meeting with regulatory agents to find out what they need to submit for an IND meeting — such as product data and animal toxicity trials, and clinical product design. After the pre-IND meeting, the manufacturer will draft the IND submission and the animal study data, and phase 1 clinical product. The regulatory agent will review and determine if they can start phase 1. The regulatory agent then works cooperatively with the companies in the development of the vaccine during phases 1, 2, and 3.
  5. Usually vaccines take several years — how did the process balance speed and quality? What is the most important thing to check for? These two vaccines have not been fully approved. This is a pandemic situation and several thousand people die every day so we have to expedite the whole process. We are not diminishing the reviewing quality, we are just putting in extra time and resources to the review. It is a very difficult process, there’s a lot of people involved to speed up the process to get these vaccines under the EUA.
  6. What is the difference between the Pfizer and Moderna vaccine? Both vaccines are messenger RNA based. Based on the scientific point of view, they are very similar and there is not much difference.
  7. What were major scientific challenges to authorizing the vaccines to public use? Because this is a novel approach, we don’t have any vaccines using this mRNA approach. People may not have confidence because we don’t have much experience. mRNA vaccines may not have been licensed, but there has been research for more than 10 years. The challenge is always education and addressing safety concerns, and explaining scientifically how those concerns may be mitigated.
  8. Do you know any people who are hesitant about the vaccine and what would you say to them? One of my friends is a nursing mom and was worried about the vaccine when breastfeeding her baby. I can tell her all the facts I know, and she has to make her own assessment. Based on the current safety data, I don’t think there is a serious concern for this vaccine. But usually we don’t include nursing moms or pregnant women in the clinical study so there’s not a lot of information.
  9. Do you think COVID-19 will ever be eradicated and what does the new UK variant mean for the future of the vaccine? I don’t know if it will be eradicated. Viruses can mutate very fast. We vaccinate for influenza every year because it is constantly mutating. Hopefully COVID-19 will behave like the one in Hong Kong in the 1990s. I’m not sure if we have sufficient information to address the UK variant. However, a journal showed that the UK variant can be neutralized by the current vaccines, which is promising news. If strains from Brazil or South Africa come to the US, the vaccines may have a protective effect.

Listen to this episode on Spotify and check out our Instagram!

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