“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority (BARDA), said Thursday as he testified at a House subcommittee hearing on the U.S. response to COVID-19.
“While it is terrifying to acknowledge the extent of the challenge that we currently confront, the undeniable fact is there will be a resurgence of the pandemic this fall, greatly compounding the challenges of seasonal influenza and putting an unprecedented strain on our health care system,” he continued. “Without clear planning and implementation of the steps that I and other experts have outlined, 2020 will be the darkest winter in modern history.”
In his testimony before the Energy and Commerce Subcommittee on Health, Bright stressed the need for more coordination and better nationwide planning that takes into consideration the critical supplies that are needed for testing and a vaccination program, along with an equitable distribution of those supplies.
“As I reflect on the past few months of this outbreak, it is painfully clear that we were not as prepared as we should have been. We missed early warning signals and we forgot important pages from our pandemic playbook,” Bright said. “There will be plenty of time to identify gaps for improvement. For now, we need to focus on getting things right going forward. We need to ensure that we have a plan to recovery and that everyone knows the plan and everyone participates in the plan.”
Part of that plan should be preparing for a nationwide vaccination program. Even though a potential vaccine is, at the least, several months away from being ready for emergency use, Bright said the government must get the supply chain ready now by securing the needles, syringes and glass vials that will be needed for a comprehensive vaccine program.
In a whistleblower complaint filed earlier this month over his removal as BARDA director, Bright said he had been warning Health and Human Services (HHS) leadership since January that the nation was far short of the 650 million to 850 million needles and syringes that would be needed to administer a vaccine in the U.S. alone.
At Thursday’s hearing, Bright noted that vaccine supplies could be even more limited in the fall when the flu season begins and as other countries increase their orders for needles and syringes. When asked about the situation, he testified that the government had placed an order May 1 and again that day for a total of 320 million needles and syringes.
(Apiject Systems America Inc., of Stamford, Conn., announced Tuesday that it was awarded a government contract valued up to $138 million to accelerate the building of a new U.S.-based, high-speed, population-scale emergency drug injection capability with prefilled syringes. Under the contract, its subsidiary, Rapid USA Inc., is to supply 100 million prefilled syringes by the end of the year. It also will purchase and stockpile 100 million needle hubs for those syringes. The company’s goal is to develop the capability to manufacture a minimum of 30 million prefilled syringes per month once therapeutic drugs and vaccines become available.)
Supplies aren’t the only vaccine concern. The government must have a coordinated plan in place on how to distribute a vaccine when one becomes available. Such a plan would specify who should get the first doses and how to stretch limited supplies. Without a plan, the “situation would be catastrophic,” Bright said, adding that no plan exists.
Of course, any plan would be contingent upon having a COVID-19 vaccine available. Responding to a question from Rep. Frank Pallone (D-N.J.) about where the government is in the hunt for a vaccine, Bright didn’t sugarcoat his answer. “Vaccines are very difficult to make,” he said, so many “shots on goal” will be needed to find one that will work against the coronavirus.
Bright put some caution to the NIH’s Anthony Fauci’s repeated statement that a COVID-19 vaccine could be available within 12 to 18 months from the beginning of development. If everything goes perfectly, a vaccine could be ready for emergency use within that timeframe, Bright said. Since “everything never goes perfectly,” he said he expects it may be longer before a vaccine is available – even under emergency use authorization. Full FDA approval of a vaccine would take even longer.
“There’s a lot of optimism. There’s a lot of hope. But that doesn’t make a vaccine,” Bright said. “There’s a lot of work that needs to be done to make a vaccine.” Under normal circumstances, it can take 10 years to develop a vaccine and get it fully approved. While some have been developed in less time, a new pathogen, such as SARS-CoV-2, presents unique challenges, Bright said.
If a vaccine is developed, no one company could produce enough of it for the U.S., let alone for the world, Bright said. Thus, the government needs to plan now about how to manufacture a vaccine and get it distributed. “It is a significant concern,” he added.
Back to the basics
Summing up his recommendations for moving forward, Bright said Americans must be told the truth about the pandemic and the consequences of their actions. That includes increasing “public education regarding the basics – handwashing, social distancing, appropriate face covering, self- and dependent monitoring, and frankly, our leaders must lead by modeling the behavior,” he said in his written testimony.
Ironically, some of the lawmakers and staff at the hearing had their face masks hanging down around their necks; some had no masks at all. Others fidgeted with their masks throughout the hearing. For instance, Subcommittee Chair Anna Eshoo (D-Calif.) opened the hearing with her mask around her neck and with gloves on her hands. She then removed her gloves. Well into the hearing, she and some of her colleagues donned their masks, but took them off and on repeatedly when they spoke, often positioning them improperly. Eshoo also put her gloves back on.
Bright himself, who said he has been on sick leave for hypertension due to the stress he’s been under at HHS, removed his mask for the hearing. His attorney, who was seated beside him – at arm’s distance – at the witness table, started the hearing with no mask. Although she put one on later, she pulled it down to speak and put her ungloved hand by her mouth.
Aside from better education on masks and the other basics, Bright’s recommendations, which he repeated throughout the hearing, included:
“The virus is out there; it’s everywhere. We need to be able to find it, to isolate it and to stop it from infecting more people,” Bright said. “We need tests that are accurate, rapid, easy to use, low cost, and available to everyone who needs them. We need to be able to trust the results so that we can trace contacts, isolate and quarantine appropriately while striving to develop a cure.”
If the U.S. doesn’t take seriously the call for action, the fall will be devastating, Bright warned, adding, “we have limited time.”