Tuesday, October 26, 2021

Scientists Grapple With Mission to Stem Covid-19 Tide

By on May 10, 2020

(Screen capture of https://twitter.com/MGH_RI)

Multi-pronged Approach Seen as Promising

SAN JUAN — The jury is still out on a document obtained by Caribbean Business that was signed by a group of leading experts who call themselves “Scientists to Stop COVID-19” and are calling for a multipronged approach that can stem the Covid-19 tide while gradually returning to public life—reopening businesses and returning people to work, albeit with great caution.

“We envision a first wave of therapies using existing drugs that will establish a beachhead in the fight against the virus (testing in April-May 2020, use immediately afterwards). A second wave of potent new antibody drugs developed specifically to neutralize COVID-19 offer a promising combination of speed, safety, and likelihood of being effective (testing in June-August 2020, use afterwards). A third wave of vaccines for long-term victory over the virus will offer seasonal or multi-year immunity to COVID-19 (testing in March 2020-March 2021, use afterwards),” reads the opening letter in the four-wave approach proposed by the scientists. “In parallel, reopening of businesses and schools to restore our society and economy (implementation in May-June 2020, lasting until the threat has passed) will use science-driven symptom reporting, virus testing, and personal protective gear to minimize future COVID-19 outbreaks and additional loss of life.”

The document, which was obtained by Caribbean Business nearly two weeks ago, is signed by renowned scientists including Nobel laureates, immunobiologists, microbiologists, chemical biologists, neurobiologists and experienced directors of public health policy (See report). The Wall Street Journal reported last week that the scientists are backed by a group of billionaires headed by Tom Cahill, “a 33-year-old physician-turned-venture capitalist,” that are backing the top scientists in an effort to gather the best research on the pandemic to pitch to the Trump administration. 

Thomas J. Cahill, MD, PhD (Screen capture of https://www.newpath.partners)

The spikes and valleys of Covid-19 cases across America and countries throughout the world amid the rush to reopen businesses and get people back to work is putting the onus on the scientific community as to how best to keep contagion at bay. The answer is always complex and multifactorial. 

“I am not familiar with their plan; as I said before, a multi-pronged approach is certainly important,” Dr. Sarimer Sánchez, an infectious disease expert doing her fellowship with Massachusetts General, told Caribbean Business during a recent interview. “The most important part of this response is sort of restoring what could be a return to normalcy. That will happen when a majority of the population can have a sort of immunity or resistance to the virus…sufficient to stop the spread of disease. What we know about this virus is how many people one given person spreads disease—we know that 50 [percent] to 70 percent of the population has to develop immunity for immunity to play out.” 

Dr. Sarimer Sánchez (Screen capture of https://twitter.com/mgh_id)

Sánchez, who is Puerto Rican, explained that antibody testing would provide a sense of what percentage of the population is already immune. The doctor pointed to early studies conducted in New York that stressed that 20 percent of their limited cohort were immune whereas in California there was a small cohort where about 3 percent to 4 percent were immune. “So, nowhere near the numbers that we need. So, we do know that a vaccine will be necessary. But, we also expect that a vaccine will take a very long amount of time—probably about 12 to 18 months,” explained Sánchez. 

“So, while you have the vaccine being researched in the background, we will need other approaches, such as repurposed drugs as well as other novel therapies in addition to some of the other social measures that we are already taking. A measure that we know works is something like social distancing. But perhaps a combination of social distancing together with a pharmacological approach until we are able to secure a vaccine,” she surmised. 

The initiative is taking place against the backdrop of a heated debate whether the economy can withstand continued lockdown as an essential component in strategies to help flatline or bring down the curve of new cases. Other scientific questions underpin exactly how much testing is actually possible and whether effective treatment and some testing is the route to go while a parallel race to find a vaccine continues in tandem.

More than Covid-19 at Stake

More than a delicate balancing act between social engineering and epidemiology, the Covid-19 menace has severely impacted billions of dollars in ongoing research at some of the nation’s largest and most prestigious health institutions. When the leadership at Massachusetts General Hospital met in early March to put in place protocols to triage for the Covid contagion that was coming down the pike, they knew swift action needed to be taken immediately. Mass General has an incident commander who leads a team that strategizes preparedness for emergencies such as the aftermath of the Boston Marathon bombings. 

Among the priorities was establishing medical safety and treatment protocols in anticipation for the coming Covid cases and securing ongoing clinical trials in a scientific research institute that employs some 8,000 specialists and has more than $1 billion in ongoing research for other diseases. 

“In preparation for the surge of COVID-19 patients and in an effort to reduce the number of people at the hospital, we had to shut down research operations,” Mass General Research Institute’s scientific director, Susan A. Slaugenhaupt, Ph.D., told Caribbean Business. “And we had to get our workers out of there because we did not need to have everyone there at one time. We limited the research people to what we call essential workers…down to about 1,500 who were given permission to access the facilities. We have a massive research operation with sensitive equipment and long-term experiments—all of that stuff had to be taken care of. So, several weeks ago it was a priority to have it shut down and secured. Then, we had the redeployment issue where we took a lot of our research workforce and redeployed them to help with things on the clinical side.”

Mass General Research Institute’s scientific director, Susan A. Slaugenhaupt, Ph.D. (Screen capture https://www.massgeneral.org)

In the massive undertaking of reshuffling research brigades, Mass General put on display a plan that worked with Swiss-clock precision but had the impact of bringing much important research to a screeching halt. “Now, we are working on reopening…on May 18 in a gradual way. We want to get people back in the labs—this has been a very difficult time for researchers. People’s careers are on the line; we need to get them back in the labs.” 

“Right now, everything is focused on Covid,” added Slaugenhaupt, who is also a professor of neurology at Harvard Medical School. “But, there are thousands of other diseases for which research has not been going very quickly. As an example, these are kids who are waiting for gene-therapy for some devastating genetic diseases who might not have positive outcomes before their therapy comes online.

“I am sure you have seen this data out there. People are having heart attacks because they are not going to the hospital because they are afraid. People are not getting screenings—colonoscopies, mammographies…. So, we need to get back to providing the appropriate care.  So, now there is a lot of communication of public service announcements—the message being: ‘Listen, we were there for you for Covid, but we are also there for you for other care. We need for you to come back—billions of dollars are being lost,’” she stressed.

Back to the drawing board

With fear stunting scientific research essential to neutralize Covid-19, a conundrum remains pertaining to the many vaccine initiatives. In their report, Scientists to Stop Covid-19 advocate for a more centralized approach in the development of a vaccine.

“Manufacturing investments are substantial and, accordingly, will likely be made by governments or large funding organizations. We must focus on manufacturing an effective vaccine at a scale that will permit world-wide use,” they stress. “In a typical vaccine development program, investments in scale-up and manufacturing are tied to an increasing understanding of a given vaccine’s clinical potential. Such a measured approach is not viable for SARS-CoV-2 [Severe Acute Respiratory Syndrome-coronavirus-2, the strain that causes Covid-19] because of the urgency. Large at-risk development decisions will need to be made, for each individual promising vaccine candidate, well before significant clinical data become available.” 

The group cites several “non-company funding sources for the large majority of SARS-CoV-2 vaccine efforts globally.” These include the Coalition for Epidemic Preparedness (CEPI), the Biomedical Advanced Research & Development Authority of the U.S. government (Barda), the Bill & Melinda Gates Foundation (BMGF), and sovereign government initiatives. 

“Among these three largest funders, an effort is ongoing to coordinate their support in a way that will allow for efficient decision-making and use of available funds for at-risk investment and development support. Such coordination requires centralized decision making to manage the activities across multiple individual promising approaches, and among the supporting functional and funding efforts—thus our recommendation to appoint an ‘empowered council’. A prospective agreement must be established primarily among the regulators, the key funders, and key global stakeholders to ensure that the empowered council has the authority to direct the overall enterprise,” the report concludes.

Competitive Collaboration

Several scientists interviewed by this newspaper are not in agreement with a centralized approach. “That is not really how it works, to have a centralized approach. I mean, what if you had the wrong people put in charge of that initiative,” Slaugenhaupt cautioned. “I think science works more on the order of collaboration/competition. The first to get there will be a big deal. But, I will say that there is more scientific collaboration than ever before—between academia and industry; alliances between several pharmaceutical companies—all working together to develop a vaccine.”

The infectious disease expert, Sánchez, agreed. “I think one of the things that has been pivotal in this response has been the sharing of information. But the scientific community has truly banded together on treatment and testing characteristics. We really benefit from getting accurate data out there,” she told Caribbean Business. “So, we are learning more and more, but we are still somewhat limited in our testing capacity. I think…it is something that we are trying to learn in this response: What is the most effective way to band together our expertise—how to boost our preparedness to get much-needed testing and other modalities up to speed in the middle of a pandemic?”

With the hyper-mitosis of government opinion flying at scientific initiatives now moving at warp speed, it is important that the government revise protocols to let experts do their work. One recent story in the Economist reported that the Centers for Disease Control and Prevention (CDC) protocols early in the Covid-19 crisis were flawed to the point of bureaucratic stagnation. The scientists interviewed for this story agree that the protocols and interaction between the CDC and the Food and Drug Administration (FDA) had been painfully cumbersome at first, but that some deregulation hurdles had since been removed. Everyone—in the regulatory realm and the scientific community—seems to agree: Time is of the essence.

It is a point addressed by Cahill’s scientific brigade: “Following a successful clinical trial, a company reports the results and formally submits a new drug application (‘NDA’). FDA review of an NDA normally takes 9-12 months. Given the state of the pandemic, we recommend that the FDA communicate daily with these companies during preparation of the NDA to assure all required components are included, and then complete the NDA review within 1 week of receipt since its questions will have already been answered prior to submission. Desired timeframe: August-September 2020.”

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