This is an excerpt from the April 27, 2021 edition of Medically Necessary, a health care supply chain newsletter. Subscribe here.
The plan: The U.S. plans to release 60 million doses of AstraZeneca’s COVID-19 vaccine, which hasn’t been approved in the U.S., to other countries.
- A White House spokesperson didn’t specify which countries would receive the vaccine.
In addition, the U.S. will share raw materials for vaccine manufacturing, therapeutics, rapid test kits, ventilators and personal protective equipment with India, which is experiencing a surge in COVID-19 cases.
- “Just as India sent assistance to the United States as our hospitals were strained early in the pandemic, the United States is determined to help India in its time of need,” a White House spokesperson said, according to a statement.
- The drugmaker Gilead says it will donate 450,000 vials of the company’s COVID-19 therapeutic remdesivir. Gilead will also help Indian drugmakers produce the drug.
The U.S. is also sending a team of public health experts to India to mobilize the emergency resources.
Backstory: More than half of adults in the U.S. have received at least one dose of a COVID-19 vaccine, but until now the country had sent relatively few doses abroad.
- In March, the White House announced it would lend about 4 million doses of the AstraZeneca vaccine to Canada and Mexico, the only doses it has shared thus far.
Last week, a State Department spokesperson argued the U.S. had to prioritize vaccinations for Americans before turning to other countries and that vaccinating Americans would indirectly protect other countries.
However, some groups have criticized that approach. Recently, the U.S. Chamber of Commerce asked the U.S. government to release its doses of the AstraZeneca vaccine to India and Brazil.
- “These vaccine doses will not be needed in the United States,” a statement from the chamber reads. “No one is safe from the pandemic until we are all safe from it.”
While the U.S. hasn’t shared many vaccines, the country has pledged financial support for vaccinating people in other countries.
- In March, the federal government announced a plan to finance increased capacity for Indian vaccine manufacturer Biological E.
- The U.S. has also committed $4 billion to COVAX, the international initiative aiming to vaccinate people in low- and middle-income countries.
Trade disputes: Over the past several months, one of India’s largest vaccine manufacturers has complained that the Biden administration’s use of the Defense Production Act has made it difficult to get raw materials.
- “We’re talking about having free global access to vaccines, but if we can’t get the raw materials out of the U.S. … that’s going to be a serious limiting factor,” Serum Institute CEO Adar Poonawalla said during a World Bank event in March.
A few weeks later, Poonawalla followed up on Twitter with a direct appeal asking the U.S. to “lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up.”
White House COVID-19 Supply Coordinator Tim Manning has pushed back on the idea that the Defense Production Act is an export ban.
- “We have used the DPA to ensure we have access to all needed supplies with many US companies. DPA in these cases just means U.S. companies must prioritize their government contracts ahead of other orders,” Manning wrote on Twitter.
Manning explained that the recent agreement essentially diverts U.S. orders for filter bags — a necessary component for COVID-19 vaccine manufacturing that has been in short supply — to India. He didn’t specify if the agreement extended to other materials.
To be fair, there are also signs that India might have imposed some kind of export restrictions on finished COVID-19 vaccines, according to The New York Times.
- In February, Poonawalla wrote on Twitter that the Serum Institute had been “directed to prioritise the huge needs of India” and that shipments of finished vaccines to other countries could be delayed.
Next steps: The federal government expects that about 10 million doses of AstraZeneca’s vaccine will be available for export within the next few weeks.
- An additional 50 million could ship in May and June, according to Reuters.
The Food and Drug Administration will need to confirm that donated doses meet expectations for quality before they are shipped.
- According to The Associated Press, the AstraZeneca doses the U.S. plans to share were produced at the same manufacturing plant the FDA recently criticized for unsuitable conditions.
States resume use of Johnson & Johnson vaccine
Back in action: Last week, The U.S. ended the pause on using Johnson & Johnson’s COVID-19 vaccine, and many states and federal jurisdictions have begun using the one-shot series once again.
Backstory: The Centers for Disease Control and Prevention and the FDA briefly paused the use of Johnson & Johnson’s COVID-19 vaccine to investigate reports of blood clots potentially related to the vaccine.
- So far, 15 women have developed serious blood clots after receiving the vaccine, according to The New York Times.
- Still, the blood clots appear to be rare. For women ages 30 to 39, the group that appears to have the greatest risk, only 11.8 in 1 million developed blood clots.
On Friday, the CDC’s Advisory Committee on Immunization Practices recommended resuming use of Johnson & Johnson’s COVID-19 vaccine.
However, a fact sheet about the vaccine and the shot’s label will include information about the possibility of blood clots, according to STAT.
The bandwagon: By Saturday, more than a dozen states had resumed using the Johnson & Johnson vaccine, according to The Associated Press.
- According to The New York Times, about 10 million doses of the vaccine were immediately available after the CDC and FDA recommended resuming use.
The doubts: However, there are signs that the pause may have made some patients less confident in the vaccine.
- On Sunday, more than 90% of available doses went unused at a Florida vaccine administration site offering the Johnson & Johnson vaccine, AP reports.
Manufacturing update: So far, Johnson & Johnson’s COVID-19 vaccine has been a relatively small part of the rollout in the U.S., representing less than 5% of all doses administered.
- Bloomberg analysts are predicting that the shot could become a much larger part of the vaccine campaign later this year, after production ramps up.
But quality issues at the Maryland plant producing drug substance for Johnson & Johnson have the potential to disrupt future production, according to Politico.
Premier offers snapshot of PPE situation
What’s happening? A report from Premier, a group purchasing organization serving more than 4,000 hospitals, offers a snapshot of how the supply of personal protective equipment has changed over the past year.
Top line: On average, health systems have significantly more personal protective equipment on hand than they did during the spring of 2020.
Masks: In the spring of 2020, the average Premier member had about a 23-day supply of N95 and K95 masks. A year later, members had on average a 200-day supply of masks.
- That’s despite the fact that, according to Premier data, mask usage quadrupled between April and December 2020.
Premier attributes the recovery to health care providers stockpiling masks when COVID-19 cases were lower.
Gowns: A Premier survey found that in the spring of 2020, members had, on average, a 20-day supply of gowns. By March 2021, that had jumped to 40 days.
- The company said the focus on manufacturing masks, which are made using a similar manufacturing process, constricted the supply of gowns.
Gloves: The average supply of gloves for Premier members jumped from 15 days in the spring of 2020 to 30 days in March 2021.
- Premier estimates that global demand for nitrile exam gloves still exceeds supply by almost 40%.