COVID-19 vaccines developed at record speed, but experts say trust the data
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In less than a year, scientists were able to develop several efficacious COVID-19 vaccine candidates — one of which was authorized for emergency use by the FDA late Friday after an advisory panel of experts backed its use.
On Sunday, the CDC’s Advisory Committee on Immunization Practices voted 11 to 0 — with three recusals for conflicts of interest — to recommend the vaccine’s use in individuals aged 16 years of age or older. CDC Director Robert R. Redfield, MD, signed off on the recommendation, and priority groups began receiving the vaccine — which was developed by Pfizer and BioNTech — on Monday.
“This is the next step in our efforts to protect Americans, reduce the impact of the COVID-19 pandemic, and help restore some normalcy to our lives and our country,” Redfield said in a statement.
Another vaccine, this one developed by Moderna Inc. and the NIH, could be authorized for use later this week.
The speed of COVID-19 vaccine development has generated a lot of excitement, but also some concerns. Healio spoke with experts to discuss what lessons can be learned from the process, and how to mitigate concerns about safety and vaccine hesitancy.
‘Robust foundation’ enables quick development
The process of developing a viable COVID-19 vaccine candidate may appear like it occurred at lighting speed — because it did, according to Infectious Disease News Editorial Board Member Jeanne M. Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham School of Medicine.
“But it’s important to remember the robust foundation that enabled that pace,” she said.
According to experts, a combination of factors, including intelligent planning and some chance circumstances, made it possible to develop vaccine candidates so quickly.
“Fortunately for humanity, COVID-19 vaccine development occurred in the spirit of a relay race,” said Gitanjali Pai MD, AAHIVS, FIDSA, Infectious Disease News Editorial Board Member and infectious disease physician at Memorial Hospital and Physicians’ Clinic in Stilwell, Oklahoma. “Every player virtually snatched the baton from the previous player and sprinted ahead, without wasting a single moment.”
According to Infectious Disease News Chief Medical Editor Paul A. Volberding, MD, professor of medicine and director of the AIDS Research Institute at the University of California, San Francisco, the intense sense of urgency drove competition at national levels, ensuring that the United States was not the only country to have a vaccine.
Aside from the global “race” for a vaccine, the background of vaccine development for infectious diseases such as Ebola, SARS and MERS contributed to the quickened pace, as did the desire of researchers to work further with messenger RNA (mRNA)-based vaccines.
“Many scientists were really interested in the use of mRNA to ‘direct’ the cell to produce proteins that subsequently elicit antibodies,” Marrazzo said. “This work goes back decades and has progressed steadily, positioning this vaccine for quick development.”
Additionally, experts agreed that funding — which is typically a problem in vaccine development — was not hard to come by during the pandemic.
“The funding hurdle, which is endemic to all research, was taken care of by, among others, the Coalition for Epidemic Preparedness Innovations founded in 2017 by Bill Gates and other organizations,” Pai said. “Bill Gates also was instrumental in prevailing upon big pharma companies to share their product information with others who can start clinical trials.”
Volberding described the funding made available by governments and companies as “massive.”
“I’m not sure we yet know what the final amounts are, but they’re well into the billions,” he said.
Also aiding the quickened pace of development was the FDA’s detailed guidance for vaccine trials.
“Clinical trials were expedited by amazing collaboration and commitment of pharma companies, regulatory authorities and ethics committees,” Pai said. “In short, all stakeholders worked together like never before for fast-track development of vaccine.”
She said this shared effort was only strengthened by the real-time data and knowledge sharing by researchers through mobile technology, which had a “multiplier effect” on the clinical trials and facilitated solutions in real time.
‘Critical’ lessons
Most of the factors that came together in 2020 to facilitate the quick development of a COVID-19 vaccine are generic and can be replicated in other vaccine projects, Pai said. These including the close collaboration between developers, funders and regulators; having an open mind to new technology platform; and the elimination of unnecessary delays.
However, she said there are some important differences between COVID-19 and other infectious diseases that may have made it easier to develop a vaccine.
“Arguably, it is easier to develop vaccines against viral diseases than bacterial diseases,” she said, noting that a tuberculosis vaccine, for example, often requires at least 3 years of follow-up with trial participants to know whether the vaccine works. Additionally, rapidly mutating RNA viruses such as HIV and hepatitis C exhibit considerable genetic diversity, which presents huge challenges in vaccine design something that COVID-19 vaccine developers did not need to take into consideration.
“The main difference, however, is the urgency in the minds of stakeholders,” Pai said. “COVID-19 has had a devastating effect on the economy and affected everyday life. That is not the case for other diseases.”
She said COVID-19 has affected the entire global population, whereas other diseases primarily affect underprivileged populations.
“That explains the lack of push from society for faster outcomes in other vaccines,” Pai said.
According to Marrazzo, the partnerships between pharmaceutical partners and federal governments that characterized the rapid response to COVID-19 are a “critical” lesson that can be applied to other infectious diseases.
“If we had an Operation Warp Speed of this magnitude aimed at developing a universal influenza vaccine, we could be there as quickly — and that is just one example,” she said.
Trust the data
The quick turnaround of COVID-19 vaccine may be an exciting development in the field, but it can also compound the significant problem of vaccine hesitancy, Pai said.
“Ironically, the hype regarding fast development may have resulted in increased skepticism in the minds of people regarding safety of the vaccine,” she said. “The message that, in spite of the incredible speed, safety has not been compromised in any way in developing vaccines has to be communicated to people by those with very high credibility and integrity and who people perceive as having no axe to grind.”
Experts said one of the best ways to get this message across to the public is to let the science speak for itself.
“We have to rely on the trials’ clinical data and trust that regulatory authorities are carefully evaluating these [vaccines],” Marrazzo said. “It’s really encouraging to see that both the U.K. and Canadian regulatory authorities [also] approved the Pfizer vaccine, for example — that says there is consensus on what the data look like and a commitment to get these out quickly.”
However, she said “we need to do our due diligence to complete the required 2-year follow-up to actively monitor adverse events in participants.”
Moving forward, experts and clinicians need to engage in frank discussions with patients, especially those most vulnerable to the consequences of infection and those most in need of protection, Marrazzo said.
“Role modeling by having respected community leaders go public with getting immunized will be critical,” she said.
Volberding said combatting the public’s hesitancy “will be tough,” but he believes that when the public sees how readily health care workers flock to receive the vaccine, they will be reassured.
“I’d much rather have a vaccine than have this virus,” he added. “It will take a concerted international campaign, and I'm sure the Biden administration will be fully supportive.”
Just because the vaccine is approved does not mean the FDA’s work is not done, Pai said.
“The FDA will have to ensure the collection and reporting of data on vaccine administration and side effects or reactions, if any,” she said. “They do plan to rigorously monitor data on immunization, and in case of any safety signals, initiate action, including informing the public in the most effective way possible.”
Reference:
Gargano OS, et al. MMWR Morb Mortal Wkly Rep. 2020;doi: 10.15585/mmwr.mm6950e2.
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