North American Virologists, Microbiologists, and Vaccine Makers Explain the Data Needed to Support Any Development
September 27, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
Jesse Goodman, Paul Offit, Deborah Fuller, William Haseltine and Richard Condit
The pandemic that still puts the world in check, with almost a million deaths, unleashed a race against time to achieve the first vaccine against the coronavirus. . Now, when several of the developments begin phase three of their trials, the alerts are lit for the speed of the process. It is not clear how complete the data will be. Business Insider brought together five prestigious North American experts in vaccines and virology to ask them what information they need to know to get the vaccine:
Virologist Richard Condit: “I am going to trust the people who carry out the trials”
Richard Condit has been studying viruses for several decades. Although he is well versed in virology and infectious diseases, his main experience does not lie in the development of vaccines so he said he will trust the most involved scientists, he said. “I'm going to trust the people who run the trials,” he said. “If they say we have enough assurance in the control group, so that we can statistically say that the vaccine has a certain acceptable level of efficacy, and they didn't see any significant adverse effects, I'm going to put it on.”
The 72-year-old retired virologist said he is closely watching for signs of political pressure in vaccine decisions. Condit claimed that he trusts pharmaceutical companies alongside scientists from the Centers for Disease Control and Prevention and the Food and Drug Administration, but not the Trump administration. “I am confident in what [Trump] would call the 'deep state,'” he said.
“I am not saying that I will receive the vaccine without reservations,” he warned. “There's a bit of nervousness associated with that, but I'm 72 years old and there's a good chance that the benefit of being vaccinated will outweigh the risk of that crap if I contract the disease.”
Ideally, Condit said, a coronavirus vaccine would be 80% or 90% effective. But you would also get vaccinated with one that is less effective but still useful, such as one that reduces the chance of getting COVID-19 by 50%. “If I can get a vaccine that reduces my chances of getting this disgusting disease by 50%, I will take it,” he said, adding that a 50% effective vaccine “is probably an interim measure that makes us safer but not completely. insurance ”.
Microbiologist Deborah Fuller thinks the vaccine is a decision of society, not individual
Deborah Fuller, a microbiologist at the University of Washington and a vaccine developer , thinks about getting vaccinated because of the benefit it will bring to the general population, rather than herself . An effective vaccine will help build the immunity of the herd and ultimately protect society against disease. Although you would love for an injection to be highly effective in preventing disease, you would also receive one that is “modestly effective.”
“I would endorse a vaccine that was 50% effective, and I would give it to myself if it was available,” Fuller said.
He added that a vaccine can remain an important benefit if it can reduce the severity of the disease, even if it means that vaccinated people may end up becoming infected and sick to some degree. “People think it's black and white, that if I get a vaccine I'm not going to get sick at all,” Fuller said, adding that the reality is more nuanced. Although people might get upset if they get vaccinated and still end up experiencing the disease, Fuller explained that they may not get as sick as they would have been without the vaccine.
Jesse Goodman, a former FDA scientist, wants to “look at the real data to make a decision.”
Jesse Goodman, the former chief scientist at the Food and Drug Administration, said he wants to review the real data before making a final decision. “If I saw a vaccine that was clearly effective in a large phase three trial, and I thought the evidence was convincing, I would get vaccinated,” said Goodman, now director of the Georgetown University Center for Access, Safety and Management of Medical Products. .
Goodman emphasized the importance of viewing actual trial results in peer-reviewed journal publications and presenting them at public meetings such as FDA advisory committee meetings. He said drug companies often highlight positive results and downplay any negative findings in press releases. “As an expert in infectious diseases and vaccines, I'm going to want to see the real data and make a decision,” he added.
Rotavirus Vaccine Inventor Paul Offit: “I want to make sure my group is represented”
The results of the study will need to show how safe and effective an experimental vaccine is for people his age in order for Paul Offit to feel comfortable with the injection. “I want to make sure my group is represented in the study,” said Offit, director of the Center for Vaccine Education at Children's Hospital of Philadelphia . “I am over 65 years old. Has my group been properly studied, and how effective is it, and what do we know about safety? ”
Offit explained that he hopes that the COVID-19 vaccine can reduce the chances of contracting a moderate or severe disease by 70%. But “anything greater than 50% is positive,” he added.
Offit is a co-inventor of the rotavirus vaccine and a pediatrician at Children's Hospital of Philadelphia. He emphasized that a vaccine could be another valuable weapon against the virus, in addition to what we already know as social distancing and the use of masks.
Biotech executive William Haseltine cares about long-term safety and efficacy
Longtime biotech executive William Haseltine has a significantly more cautious outlook on a new vaccine than other experts. You want to see long-term safety and durability data before you vaccinate yourself, or recommend one to your family.
“When people ask me, 'Are you going to get vaccinated, Bill?' My answer is that I'm going to wait a couple of years, me and my family,” he said.
Haseltine is a former Harvard medical professor, where he founded two research centers focused on HIV / AIDS and cancer. The virology and infectious disease expert is now president of ACCESS Health International, a non-profit group of health experts. He also founded and ran several biotech companies, including Human Genome Sciences, which was eventually bought by GlaxoSmithKline for $ 3 billion.
His main concern is theoretical. You are concerned that long-term follow-up data shows that the protection of these vaccines is declining. In particular, he is concerned that it could leave people more vulnerable to infection, and potentially make the resulting illness more severe after receiving the vaccine.
While this risk, generally known as antibody-dependent enhancement, has been seen in other experimental vaccines, recently against dengue virus, there is no data pointing to it as a problem for this new coronavirus.
Still, Haseltine said she wants to see the long-term data before getting the vaccine to ease her concerns. “I don't know if the infection is going to get better or the disease is going to get better,” Haseltine said. “And we won't know for a long time. The first piece of information is that yes, we are going to have some protection ”.