Leaders of the five biopharmaceutical companies working on some of the top candidates for COVID-19 vaccines told Congress Tuesday they will have shots available by early 2021, but said they will rely on the federal government to determine how to distribute them.
“Unfortunately, today the pandemic is far ahead of us, but we in the biopharmaceutical industry are closing in faster than we ever imagined possible,” said Dr. Julie Gerberding, a vice president and chief patient officer at Merck.
Gerberding, the former director of the Centers for Disease Control and Prevention from 2002-2009, said there has been no political pressure to lower standards to speed up the vaccine. She said was “relieved” by the rigor of the Food and Drug Administration’s guidelines for COVID-19 vaccine development.
“Speed is important but we will not compromise careful scientific efficacy, quality and above all safety as we evaluate the candidates, despite the emergency we all feel,” Gerberding said.
Lawmakers heard from the vaccine developers at a virtual hearing in the House Energy & Commerce Subcommittee on Oversight and Investigations. Colorado Democrat Rep. Diane DeGette, the chair of the committee, said the updates on vaccine development are a “rare bit of good news in a harrowing time.”
“We’re now six months into this national public health crisis and COVID-19 case numbers are continuing to climb at a staggering rate. Today more than 140,000 Americans have lost lives to this disease,” DeGette told the panel.
“As long as the Trump administration continues to shirk their responsibility to lead a coordinated national response effort, sickness and deaths are going to continue to mount. It is also clear we are not going to be able to contain this without a rapid and robust deployment of public health measures and medical countermeasures, including a safe and effective vaccine,” DeGette said.
The hearing came as President Donald Trump shifted his tone on the virus Tuesday, telling reporters it would “probably, unfortunately, get worse before it gets better,” according to The Washington Post. The U.S. has the highest number of coronavirus cases in the world.
The North Carolina Department of Health and Human Services reported 105,001 confirmed cases of COVID-19 on Wednesday; 1,698 people in the state have died of the disease.
‘Encouraging, early signs’ on vaccine timelines
There is a massive worldwide effort to develop vaccines and treatment for COVID-19. There are more than 660 unique compounds in various stages of development, including 173 vaccine candidates, 196 antivirals and 292 treatments, according to Gerberding.
The United States has already invested nearly $2.3 billion in the effort to find a vaccine.
Each of the five companies that testified before House lawmakers Tuesday have had promising responses in early trials for their vaccines. Several, including AstraZeneca and Moderna, have begun to test the vaccines on humans and published positive results. They both found the creation of COVID antibodies and a T-cell immune response that could help fend off future infections.
“Everybody knows time is of the essence in the search for a vaccine and obviously everybody wants one as quickly as possible, but we need to make sure it is going to be safe and effective,” DeGette said. She asked the medical executives for a “quick and honest assessment” on the likelihood of success and timeline for the vaccines.
Most said they expect to have millions of doses available by 2021, depending on the success of their Phase Three trials. The first two trials of vaccines focus primarily on smaller groups of volunteers that are healthy. Phase Three will branch out to test tens of thousands of volunteers representing a spectrum of ages, races and risk groups.
Some clinical trials will take place at sites in North Carolina, including: UNC-Chapel Hill, Tryon Medical Partners, Charlotte; Carolina Institute for Clinical Research,Fayetteville; M3 Wake Research, Raleigh; Trial Management Associates, Wilmington; Wake Forest University Health Sciences, Winston-Salem.
The executives testifying before DeGette’s committee were largely optimistic.
“We have a line of sight on a clear, critical path to be able to deliver up to 100 million vaccines on a commercial scale in 2020 and up to a billion in 2021,” said John Young, chief business officer for Pfizer, the only company at the hearing that did not take federal research money. “There are encouraging early signs but there is much work left to do.”
Once a vaccine is approved, there remains the question of how to get it to the people that need it. Each of the company executives said they would rely on the government to allocate and distribute the vaccines — an approach that concerned some Democrats.
“The availability of ancillary supplies for a vaccine will require coordination … past supply failures by this administration make me wary,” said Rep. Paul Tonko (D-NY).
Rep. Jan Schakowsky (D-Ill.) asked each company if it would make their vaccine available at cost: Most replies were in the negative.
“We will not sell it at cost, no ma’am,” said Moderna president Dr. Stephen Hoge. Moderna received $480 million from the U.S. government to help speed its research on a vaccine.
Gerberding said Merck would also not offer its vaccine at cost.
Dr. Mene Pangalos, executive vice president at AstraZeneca, said that under the terms of its agreement with the U.S. government, his company would offer the first 300 million doses to the government without making a profit. And Johnson & Johnson’s head of clinical development, Dr. Macaya Douoguih, said it plans to offer the vaccine at a “not for profit price during the emergency pandemic.”
Young said Pfizer, which together with the firm BioNTech signed a $1.95 billion agreement yesterday with the government to provide 100 million vaccine doses, would charge a price “consistent with the urgent global health emergency” during the pandemic.
‘Not loosening any standards’
Trump has promised a vaccine by the end of the year, also raising concerns among some Democrats that his administration would rush to approve one. But company executives said there has been no political pressure to speed up a vaccine and compromise safety or efficacy.
“The FDA is not loosening any standards,” Gerberding said.
But Rep. John Sarbanes, a Democrat who represents Maryland’s 3rd District, was skeptical. “There is a tension between safety and speed,” Sarbanes said. “Tell me why it is you are able to move so fast without sacrificing safety, when we lay that against what the normal procedures would be?”
Company executives replied that their unusually fast timelines for vaccine development are a result of collaboration, extra funding for research, and prioritization from the FDA, including clear guidelines ahead of time on what will be needed for approval.
AstraZeneca’s Pangalos said the global nature of the vaccine creates many backstops. His company this week published a new study that shows promising early findings on its vaccine candidate.
“Remember this is going to be a vaccine that is going to be used globally, so every regulatory authority is going to have a view on the safety and efficacy of our vaccine,” Pangalos said. He said the FDA’s guidelines “do not lower standards in any way.”
FDA released detailed guidance at the end of June detailing what would be necessary for a vaccine to be approved. One requirement is that it must be at least 50% effective at preventing COVID-19 infections.
