In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA).

Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses. Just as the nation’s inadequate supply of swabs and reagents delayed testing for the coronavirus, a limited availability of syringes and needles could stymie a vaccination program.

In January, when BARDA first started forming partnerships to accelerate the development of COVID-19 vaccines, Bright and his team of vaccine experts estimated that between 650 million to 850 million needles and syringes would be needed to administer a vaccine in the U.S. alone. The team also estimated that it could take up to two years to produce that quantity.

Currently, the Strategic National Stockpile (SNS) contains about 15 million needles and syringes, about 2% of what will be needed, according to Bright’s complaint.

Since January, Bright said, he has repeatedly raised his team’s concerns with Health and Human Services (HHS) officials, including his supervisor, Robert Kadlec, head of the Office of the Assistant Secretary for Preparedness and Response (ASPR), as well as Federal Emergency Management Agency (FEMA) supply chain groups. He warned the officials of the limited inventory of critical vaccine supplies and “rumblings” that other countries were already buying up what was available. He recommended that the U.S. halt the export of needles and syringes, place orders for the supplies and ramp up production.

In a March 12 email to an HHS official, Bright advised the department to attend to the vaccine supply issue “so we are not chasing things down when we need them later and they are all procured by other countries.”

Bright also shared his concerns with Peter Navarro, a White House trade adviser, who added his voice to the call to action. Navarro sent memos to the White House chief of staff and members of the coronavirus task force, “urging immediate action and implicitly criticizing HHS leadership for its failure to act,” according to the complaint. Ultimately, the White House began referring to ASPR as a bottleneck, Bright said.

The vaccine supply issues go beyond needles and syringes. Bright also notified HHS officials about a global shortage of glass vials that are needed in vaccine production. “According to major glass producers, all major pharmaceutical tubing suppliers are sold out of borosilicate tubing,” Bright said in a footnote in his complaint. “It could take up to two years to produce enough vials for U.S. vaccine needs, while some therapeutics will also require vials.”

Mike Piccarreta, a partner at global consulting firm Kearney who works with life sciences companies in sourcing and manufacturing problems, confirmed to BioWorld that the availability of glass and syringes is a real problem right now for his clients.

Too often, people think only of the drug substance when they consider manufacturing constraints. But producing a finished drug or vaccine entails more than the drug ingredients, Piccarreta said. For instance, hand sanitizer, which has been in short supply throughout the pandemic, is a necessity in drug manufacturing facilities. Some firms have had to convert resources to making hand sanitizer for internal use so they can continue to manufacture needed drugs.

Such supply constraints are being overlooked in all the talk to rush a vaccine to market. No one at HHS or FEMA has heeded the urgency of securing essential vaccine supplies, Bright said. Instead, HHS and FEMA debated about which agency should make the purchases. And Kadlec allegedly told Bright that they should wait until they had something to inject.

“To date, HHS has still not placed an order for these critical supplies,” Bright said in Tuesday’s complaint. “Lack of leadership and action by the ASPR SNS organization has placed the health and safety of all Americans at risk of not being protected by the deadly coronavirus even when a vaccine becomes available.”

No sample sharing

Aside from Bright’s warnings about the looming shortage of vaccine supplies, HHS also ignored his repeated requests in January to get virus samples from China, where SARS-CoV-2 first emerged. “Sequences alone are insufficient for potential MCM [medical countermeasure] development and assessment. … For national security, we need more,” Bright said in a memo Jan. 12, the day the first COVID-19 case was reported outside of China.

But as of Jan. 27, no one from HHS had officially requested samples from China. As HHS Secretary Alex Azar was preparing for a call that day with Minister Ma Xiaowei, of China’s National Health Commission, he was advised by the CDC that virus samples from China weren’t needed, according to Bright’s complaint.

That same day, Bright participated in an HHS COVID-19 meeting. Frustrated with the slow pace of getting samples from China, Bright said he asked why the CDC, which was getting samples from other countries, was delaying sharing them with BARDA and companies to allow for the development of MCMs such as diagnostics, therapies and vaccines.

Bright said the CDC’s Nancy Messonnier responded that he should know better than to make that request because he was aware the CDC’s agreements with other countries prevented it from sharing virus specimens even within the U.S. government.

On Feb. 9, Navarro sent a memo to the White House Coronavirus Task Force, urging it to direct HHS leadership to immediately fund and initiate a “Manhattan Project” for COVID-19 vaccine development. “If we start this week to fast track vaccine development with appropriate funding, we can likely have a vaccine to clinical trials within 7 months and a workable vaccine by October or November, with a production capacity of 150 million doses by the end of the year IF we act NOW,” Navarro said in the memo. On Feb. 14, Navarro sent a memo about the need to secure syringes and needles so those doses could be administered, according to Bright’s complaint.

A week later, the U.S. confirmed 20 more cases of COVID-19, bringing the total in the country to 35. That same day, the Association of Public Health Laboratories reported that only three states were capable of testing for the coronavirus: California, Nebraska and Illinois. The first COVID-19 death in the U.S. was reported Feb. 29.

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