A safe, effective COVID-19 vaccine may be available by the end of the year or early next year, as will the supplies needed to deliver and administer hundreds of millions of doses.

That’s the message five biopharma executives delivered to a House subcommittee July 21 as they updated U.S. lawmakers on the progress their companies are making on the vaccine front.

“That’s a rare bit of good news in this harrowing time,” said Rep. Diana DeGette (D-Colo.), chair of the Energy and Commerce Subcommittee on Oversight and Investigations. But in the next breath, she warned, “Plenty can still go wrong, so the anticipated timeline is not guaranteed.”

Even if the timeline does play out and a safe, effective vaccine is launched, DeGette said questions remain about how delivery will be prioritized and what impact a growing hesitancy toward vaccines in general, and a COVID-19 vaccine in particular, would have on the ability to reach herd immunity.

“The value of any future COVID-19 vaccine lies in the willingness of the American people to get vaccinated and their ability to get access and to afford it,” DeGette said.

Rep. Mike Burgess (R-Texas) noted that, historically, price has not been an obstacle to vaccines. In the case of the SARS-CoV-2 vaccine, some companies have committed to providing their vaccines, if approved, at cost. Others would make a vaccine available at “not-for-profit pricing.” And a few have simply assured that their vaccines will be “reasonably priced.”

While Burgess didn’t see affordability as a barrier, he said vaccine hesitancy is a bigger issue. He wasn’t the only one.

Rep. Anna Eshoo (D-Calif.) also recognized that challenge, saying she wanted to hear from industry on how Congress can tackle the “pervasive vaccine hesitancy in our country.”

John Young, chief business officer for New York-based Pfizer Inc., testified, “I thinks vaccine hesitancy is probably one of the greatest challenges for public health that America is facing.” He said industry needs to play a role in countering that sentiment by showing that its vaccines are safe and effective.

“I couldn’t worry about this more,” Julie Gerberding, executive vice president and chief patent officer at Merck & Co. Inc., of Kenilworth, N.J., said about vaccine hesitancy. She suggested that industry and government agencies engage with doctors about vaccine safety so they can translate that at the community level.

Vaccine hesitancy has become an increasingly bigger challenge over time, said Macaya Douoguih, head of clinical development and medical affairs at Johnson & Johnson’s Janssen Vaccines. A solid education about vaccine safety and efficacy is needed now if Americans are going to embrace a COVID-19 vaccine, she added.

“It’s not only about access, it’s about people willing to accept the vaccine,” Douoguih said. “And they need to have trust and confidence not only in the safety and efficacy but also have their concerns answered.”

Feeding the fears

Throughout the hearing, some lawmakers themselves fed into the fears feeding vaccine hesitancy, questioning the speed at which the vaccines are being developed and playing to political talking points by suggesting the FDA will be pressured to lower its standards for the vaccines.

For instance, in his opening statement, Energy and Commerce Chair Frank Pallone (D-N.J.) said, “We all want a COVID-19 vaccine to be developed as soon as possible, but before a vaccine is distributed, public health experts must ensure that it is safe, effective and available to all who need it. My fear is that FDA will be forced by the Trump Administration to approve a vaccine that lacks effectiveness.”

In questioning the witnesses, Pallone said, “Historically, I’ve been very confident in the FDA.” However, he added, there was a “real possibility” that President Donald Trump would pressure the FDA to lower the effectiveness standard from the current 50%. He wanted assurance that industry would push back against such an effort and would inform Congress if it were to happen.

While the industry executives expressed their commitment to developing effective vaccines that meet the current guidelines and being transparent about both safety and efficacy data, they pushed back against Pallone’s hypothetical that a substandard vaccine would be marketed.

“The FDA should be commended for publishing clear, transparent, evidence-based guidelines that set an appropriate high standard on both safety and efficacy of vaccines. … The American public and Congress, in fact, should be confident that any vaccine that is approved should meet those standards for safety and effectiveness,” Young said.

Mene Pangalos, executive vice president for biopharmaceuticals R&D at Astrazeneca plc, of Cambridge, U.K., responded to Pallone’s concerns, saying that in all his company’s interactions with the FDA, there has been no evidence that the standards would be lowered for the COVID-19 vaccines.

Rep. Brett Guthrie (R-Ky.), ranking member of the subcommittee, gave the witnesses an opportunity to address suggestions that the unprecedented speed at which the vaccines are being developed comes at the sacrifice of safety and efficacy. He noticed that the fastest a vaccine has been developed in the past was the four years it took to get a mumps vaccine to market. With the SARS-CoV-2 vaccine, the timeline is 18 months.

Pangalos explained that what’s unprecedented is how industry is interacting with regulators across the globe and how biopharma employees are working 24/7 to produce a safe and effective vaccine.

Hoge agreed that literally working around the clock is making it possible to expedite the development, but he stressed that the vaccine candidates are going through full phase I, II and III programs. For example, Moderna Inc.’s phase III trial will test its vaccine in 30,000 people, with a large percentage of those being elderly or people with co-morbidities – those most at risk for life-threatening COVID-19 infections.

The shortened timeline also is possible because industry is doing several steps in parallel, Douoguih said. Rather than waiting to see if a vaccine candidate is living up to its promise, companies are taking the risk of investing in manufacturing capacity while the product is in early development. That cuts time.

Because of the shortened timeframe, Douoguih said J&J is working on a plan for postmarket surveillance and it will monitor the long-term safety of its vaccine, if it’s approved.

Companies also are putting to use lessons from past experience and vaccine development. Pfizer, which is partnering on a few vaccine candidates, was able to leverage a few years of basic science its partner had developed for a vaccine platform used to tackle influenza, Young said.

National strategy needed

Another theme heard throughout the hearing was the urgent need for a national strategy for rolling out a vaccine once one is available and ensuring it goes first to those most at risk. Part of that strategy needs to focus on education to overcome the anti-vaccine sentiments that have taken root in the U.S., DeGette said.

Some lawmakers pinned the responsibility of developing a national strategy that ensures equitable delivery of the vaccines on industry. Since four of the five companies represented at the hearing have received government funding to help in the development of their vaccines, Rep. Joseph Kennedy (D-Mass.) said they have a responsibility “to those investors as well,” referring to taxpayers. (Pfizer declined federal assistance.)

“You have a commitment to the social good and a commitment to righting the wrongs of past decisions that have priced life-saving medicines out of those … communities” that have health disparities, Kennedy said.

Under its contract with the Biomedical Advance Research and Development Authority, Astrazeneca will be giving 300 million doses of vaccine to the U.S. government, which will be responsible for distributing the doses, Pangalos said.

While Hoge agreed a plan is needed to ensure the vaccines go to people with the highest risk, he said industry will be relying on the government to make that happen. Other witnesses indicated that professional health care groups likely will weigh in on the government’s strategy.

“All of you are relying on a government that couldn’t procure proper PPE [personal protective equipment] for wide swathes of this population. ... Clearly the federal government has failed here, multiple times over,” Kennedy said.

He urged the companies to intentionally make their own efforts to ensure the vaccines are distributed to communities with health disparities. The consequences of not doing it right will be dramatic for the country, Kennedy said.

Published here.