Infectious Disease

COVID-19 vaccines have been developed at document velocity, however specialists say they belief the info

December 14, 2020

5 min read

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Disclosure:
Marrazzo, Pai, Redfield and Volberding do not report any relevant financial information.

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In less than a year, scientists were able to develop several effective COVID-19 vaccine candidates, one of which was approved for emergency use by the FDA late Friday after a panel of experts endorsed its use.

On Sunday, the CDC’s Advisory Committee on Immunization Practices voted 11-0 – with three disagreements for conflicts of interest – to recommend the vaccine for people aged 16 and over. CDC director Robert R. Redfield, MD, The recommendation was signed, and priority groups received the vaccine developed by Pfizer and BioNTech on Monday.

Paul V vaccine quote

“This is the next step in our efforts to protect Americans, lessen the impact of the COVID-19 pandemic, and help restore our lives and lands to normal,” Redfield said in a statement.

Another vaccine being developed by Moderna Inc. and the NIH could be approved for use later this week.

Robert R. Redfield

Jeanne M. Marrazzo

The pace of development of COVID-19 vaccines has generated a lot of excitement but also some concern. Healio spoke to experts to discuss what lessons can be learned from the process and how to address safety and hesitant vaccine concerns.

‘Robust foundation’ enables rapid development

The process of developing a viable COVID-19 vaccine candidate might look like it happened at the speed of light – according to the editor at Infectious Disease News Jeanne M. Marrazzo, MD, MPH, Director of the Department of Infectious Diseases at the University of Alabama at the Birmingham School of Medicine.

Gitanjali pai

“But it’s important to remember the solid foundations that made this pace possible,” she said.

According to experts, a combination of factors, including intelligent planning and some random circumstances, allowed vaccine candidates to develop rapidly.

“Fortunately for humankind, the COVID-19 vaccine was developed in the spirit of a relay race,” he said Gitanjali Pai MD, AAHIVS, FIDSA, Infectious Diseases News Board member and Infectious Disease Physician at Memorial Hospital and the Medical Clinic in Stilwell, Oklahoma. “Each player practically grabbed 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, As a professor of medicine and director of the AIDS Research Institute at the University of California at San Francisco, that intense sense of urgency led to a national competition that ensured the United States wasn’t the only country that had a vaccine.

In addition to the global “race” for a vaccine, the background of vaccine development for infectious diseases such as Ebola, SARS and MERS contributed to the accelerated pace, as did the researchers’ desire to continue working with vaccines based on messenger RNA (mRNA).

“A lot of scientists were really interested in using mRNA to ‘direct’ the cell to produce proteins that then make antibodies,” Marrazzo said. “This work goes back decades and has steadily evolved to position this vaccine for rapid development.”

In addition, the experts agreed that funding – which is usually a problem with vaccine development – was not difficult to come by during the pandemic.

“The funding hurdle, which is endemic to all research, was overcome, among others, by the Coalition for Innovations to Prepare for Epidemics, founded by Bill Gates and other organizations in 2017,” said Pai. “Bill Gates was also instrumental in helping large pharmaceutical companies share their product information with others ready to begin clinical trials.”

Volberding described the funds provided by governments and companies as “massive”.

“I’m not sure we still know what the final amounts are, but they are well in the billions,” he said.

The accelerated pace of development was also aided by the FDA’s detailed guidelines for vaccine trials.

“Clinical trials have been accelerated by the amazing collaboration and dedication from drug companies, regulators and ethics committees,” said Pai. “In short, everyone has worked together like never before to accelerate vaccine development.”

She said that this joint effort was only reinforced by real-time data and knowledge sharing among researchers through mobile technology, which had a “multiplier effect” on clinical trials and enabled real-time solutions.

“Critical” lessons

Most of the factors that came together in 2020 to facilitate the rapid development of a COVID-19 vaccine are generic and can be replicated in other vaccine projects, Pai said. This includes close collaboration between developers, funders and regulators. Openness to new technology platforms; and the elimination of unnecessary delays.

However, she said there are some key differences between COVID-19 and other infectious diseases that may have made a vaccine easier to develop.

“It’s arguably easier to develop vaccines against viral diseases than against bacterial diseases,” she said, noting that a tuberculosis vaccine, for example, often requires at least three years of follow-up with study participants to see if the vaccine is working. In addition, rapidly mutating RNA viruses such as HIV and hepatitis C display considerable genetic diversity, creating major vaccine design challenges that COVID-19 vaccine developers did not need to consider.

“The main difference, however, is the urgency in the minds of the stakeholders,” Pai said. “COVID-19 has devastating effects on the economy and everyday life. This is not the case with other diseases. “

She said COVID-19 has affected the entire world population, while other diseases mainly affect disadvantaged populations.

“That explains the lack of societal pressure for faster results with other vaccines,” Pai said.

Marrazzo said 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 ​​this magnitude to develop a universal influenza vaccine, we could be there just as quickly – and that’s just one example,” she said.

Trust the data

The rapid implementation of the COVID-19 vaccine may be an exciting development in this area, but it can also exacerbate the significant problem of vaccine delay, Pai said.

“Ironically, the hype about its rapid development may have made people more skeptical about the safety of the vaccine,” she said. “The message that despite the incredible speed of vaccine development, safety has not been compromised in any way needs to be conveyed to people by people with very high levels of credibility and integrity who assume they have no ax 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 clinical data from the studies and trust that regulators will carefully evaluate them [vaccines]”Said Marrazzo.” It is really encouraging to see both UK and Canadian regulators [also] For example, approved the Pfizer vaccine – that is, there is a consensus on what the data looks like and an obligation to get it out quickly. “

However, she said, “We need to conduct our due diligence to complete the required 2-year follow-up and actively monitor participant adverse events.”

Going forward, experts and clinicians need to have open conversations with patients, especially those who are most vulnerable to the effects of infection and who need protection most, said Marrazzo.

“Modeling roles by having respected community leaders public with vaccination will be critical,” she said.

Volberding said addressing public hesitation is “difficult” but he believes the public will be reassured to see how quickly healthcare workers rally to receive the vaccine.

“I would much rather have a vaccine than this virus,” he added. “It will take a concerted international campaign and I am sure that the Biden administration will fully support it.”

Just because the vaccine is approved doesn’t mean the FDA’s job isn’t done, Pai said.

“The FDA needs to ensure that data on vaccine administration and any side effects or reactions, if any, are collected and reported,” she said. “They plan to closely monitor immunization data and take action in the event of any safety signals, including informing the public in the most effective manner possible.”

References:

Gargano OS et al. MMWR Morb Mortal Wkly Rep. 2020; doi: 10.15585 / mmwr.mm6950e2.

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