A cure for COVID vaccine anxiety?

Daniel J. Munoz//September 11, 2020//

A cure for COVID vaccine anxiety?

Daniel J. Munoz//September 11, 2020//

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The breakneck speed at which drug manufacturers in the United States are trying to develop a COVID-19 vaccine has been widely viewed as political in nature, and potentially unscientific. After all, the fastest any vaccine was developed was the mumps vaccine, which began testing in 1963 and was licensed by Merck in December 1967.

And so that skepticism is widely understandable, according to Michael Gusmano, a professor at the Rutgers School of Public Health.

“Suppose an under-tested vaccine caused harm or failed to deliver its benefit,” he said in a statement. “That could undermine public trust in other highly safe, effective vaccines and drug companies, which are already under attack from the anti-vaccine movement.”

On Sept. 8, the nation’s nine largest drug manufacturers rolled out a pledge that any COVID-19 vaccine they produce would be developed and tested with “high ethical standards and sound scientific principles.”

All nine companies said they would only submit a potential vaccine for approval or emergency use authorization to the U.S. Food and Drug Administration “after demonstrating safety and efficacy through a Phase 3 clinical study.”

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” reads the joint statement from the nine chief executive officers.

Three of those companies – Johnson & Johnson, Merck and Sanofi – have major headquarters in New Jersey. The other companies are AstraZeneca, BioNTech, GlaxoSmithKline, Moderna, Novavaax and Pfizer.

“The safety pledge indicates the pharmaceutical industry recognizes the impact of public trust and that a premature release of a COVID-19 vaccine will undermine public health and leave many people unwilling to accept a vaccine that has not completed appropriate testing in Phase 3 clinical trials,” Gusmano said.

U.S. President Donald Trump indicated he wants a vaccine available before November; drawing the sharp rebuke of his Democratic opponent for the nation’s highest office, former U.S. Vice President Joe Biden.

“He has said so many things that aren’t true I am worried that if we do have a really good vaccine people are going to be reluctant to take it,” Biden said at a public appearance in Pennsylvania during Labor Day weekend.

Both the FDA and the Centers for Disease Control and Prevention said a vaccine could be available within the next few months—despite prior statements to the contrary from the FDA.

That’s prompted concerns from health care experts that the scientific, largely non-political agencies are facing mounting pressure from Trump.

Cathy Bennett, president, New Jersey Hospital Association.
Bennett – NJHA

“The population must have confidence in the vaccines that come to market to begin achieving that broad immunity we need against this novel virus,” Cathy Bennett, president and chief executive officer of the state’s hospital trade group the New Jersey Hospital Association, said in a statement.

Earlier in the month, drugmaker AstraZeneca paused its vaccine trials following the emergence of an unexplained illness in one of the participants. But Dr. Anthony Fauci, one of the nation’s most prominent infectious disease experts, said in a Sept. 9 media appearance on “CBS This Morning” that halting vaccine trials is “not uncommon.”

“It’s one of the safety valves that you have on clinical trials,” he said.

A letter signed in early August by 417 vaccine and health care experts warned the FDA that the Trump administration’s so-called “Operation Warp Speed,” to quickly get out a vaccine that could be distributed across the country, was overly politicized and lacking in scientific efficacy.

Those who signed off on the Aug. 5 letter to FDA Commissioner Stephen Hahn include former federal officials at the FDA and CDC, professors at the John Hopkins School of Public Health, and former U.S. Surgeon General Joycelyn Elders.

“We can only perform as advocates if we ourselves are persuaded that the vaccine(s) truly is safe and effective. We must be able to explain to the public what we know and what we don’t know about these vaccines. For that to happen, we must be able to witness a transparent and rigorous FDA approval process that is devoid of political considerations,” the letter reads.

Debbie Hart, president and CEO, BioNJ
Hart – BIONJ

Debbie Hart, founding president and chief executive officer of BioNJ, the state’s trade group for the pharmaceutical industry, maintained that she was confident, however, that drugmakers could resist external pressures, be it political or otherwise.

“There is pressure but I think the industry communication was to reinforce the fact that they’re not responding to any kind of pressure,” she said in an interview. “The process is just being expedited, but no steps are being cut.”

The pressure is at the state level too, however.

Gov. Phil Murphy has reiterated that the litany of restrictions meant to halt the spread of the virus throughout New Jersey would stay in place in some form until a vaccine or therapeutic treatment is widely available. Adding at a Sept. 8 press briefing that he was highly skeptical either would be available by early November.

“I think we had been led to believe sort of year end would be at least a wave to address vulnerable communities, frontline health care and other essential workers,” he said.

Dozens, if not hundreds of potential vaccines and treatments are being developed. The most notable drug so far is Remdesivir, developed by Gilead and approved across much of the world in May, which shortens the recovery time from the virus by several days.

Roughly 60 separate drugs are being developed by companies in New Jersey, Hart said. Hence the state’s title as “the medicine chest of the world.”

Already, Rutgers University is renowned for the rapid-turnaround COVID-19 saliva test.

ADMA Biologics in Ramsey is looking at a plasma-based treatment, AIM Immuno Tech in New Brunswick and Bridgewater-based Lilly are looking at potential treatments, Cranford-based Citius Pharmaceuticals is working on a treatment for COVID symptoms, Orthobond in Princeton is working on a treatment that would kill the virus on high-touch surfaces and Summit-based Seqirus is looking at potential vaccines.

“We’re hoping for more successes from New Jersey-based companies,” Hart said. “At the end of the day it would be wonderful from a New Jersey company [but] we all just want a vaccine, from wherever it comes.”