Johnson & Johnson under pressure to deliver promised vaccine doses to states

Delays could undercut vaccinations in areas lacking access to deep freezers needed for one of the other authorized COVID-19 vaccines

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Posted March 23, 2021 at 3:12pm

Johnson & Johnson is under pressure to deliver its promised 20 million vaccine doses by next week, as several state public health officials indicate they are receiving few or no shots this week and have no idea how much they’ll get later.

The uncertainty comes at a time when the demand for vaccines continues to overwhelm supply, a weary country braces for the spread of viral variants and hundreds of people die from COVID-19 each day. It raises questions about how successful the company was in meeting a central goal of the massive U.S. investment in vaccine development: to manufacture sufficient supplies of shots before they were proven effective in order to hit the ground running. 

The delays could undercut vaccinations in rural and low-income areas without access to deep freezers needed for one of the two other authorized vaccines. Johnson & Johnson’s single-dose shot is helpful in those places since it’s durable for three months in the refrigerator.

The bumpy supply also jeopardizes President Joe Biden’s promise, made days after his inauguration, to be more transparent by giving states three weeks’ notice of upcoming supply. 

Federal officials have told states they expect supply to pick up but have acknowledged uncertainty.

“We are going to see a nice increase in Johnson & Johnson this week,” Andy Slavitt, White House senior adviser for the COVID-19 response team, said Monday. He declined to give precise numbers on the quantity of doses. 

“I wouldn’t signal to you that they’re going to be far away from the numbers that they have projected at all, give or take a little bit,” he said. “Obviously, we’re holding them accountable and working closely with them.”

The 20 million target was revised down from the 37 million vaccine doses the company initially set out to deliver by the end of March under the contract it signed with the U.S. government last year. 

If the 37 million doses are delayed by longer than a 30-day grace period, the government can decline to pay for any supplies that have not arrived, but advocates say that is not a big enough stick to compel the company to make doses on time. 

Johnson & Johnson said it expects to hit the 20 million target. 

“The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.,” said Srey Dasgupta, a Johnson & Johnson spokesperson. Dasgupta did not respond to a question about the original goal.

The government has dedicated about $1.5 billion to the vaccine, according to the Congressional Research Service

Some experts stress there are many challenges in scaling up in a pandemic, while others say the industry is not incentivized to invest in innovative methods. 

Arizona, Washington state and Indiana officials all said they didn’t know how much Johnson & Johnson vaccine to expect through the end of March. 

Kentucky, Idaho and Wyoming say they expect some doses this week, but the amounts are a fraction of their first shipments. 

In Florida, mass vaccination sites operated by the Federal Emergency Management Agency plan to shift to administering only second shots of other vaccines as the Johnson & Johnson supply runs low. 

The federal government shipped some doses to pharmacies after its Food and Drug Administration authorization, so the small distributions to states are not a complete picture of supply. 

The Centers for Disease Control and Prevention referred questions about how many Johnson & Johnson doses will be distributed by April 1 to the Department of Health and Human Services. HHS did not respond.

The delivery schedule spelled out under the contract is that 2 million doses should have been delivered by Feb. 1; another 10 million doses by March 1; and another 25 million by April 1, totaling 37 million doses by April. 

The contract calls for two batches of 25 millionmore doses to be delivered by May 1 and June 1. A final batch of 13 million is due by July 1. 

Doses are deemed on time, the contract reads, “to the extent that they are made up to 30 calendar days after the applicable delivery date, due to delays related to manufacturing, testing, or release.”

The deal was reached under Operation Warp Speed, the Trump administration Pentagon-HHS team that led vaccine development and manufacturing.

Critics say the contract should have provided more of a deterrent to delays amid a worldwide scramble for shots.

“The Trump administration signed deals that allowed the companies to say the doses will come when they come, with little consequence,” said Zain Rizvi, a Public Citizen legal researcher specializing in pharmaceuticals.

Advocates for global vaccine access say the company could do more by sharing the vaccine “recipe,” patented details about how to make the vaccine, with more companies, but that Johnson & Johnson is withholding its proprietary information to protect profits. 

“The shortages are the entirely predictable result of handing one corporation a monopoly over taxpayer-funded knowledge,” Rizvi said.

Lack of ‘imagination’ hurts production

Johnson & Johnson, with help from the Trump and Biden administrations, recently reached a deal with Merck to scale up production. 

“These two companies, competitors, have come together for the good of the nation, and they should be applauded for it. It’s truly a national effort, just like we saw during World War II,” Biden said in a prime-time speech.

Johnson & Johnson also outsourced manufacturing to at least six other institutions in more low-profile agreements, according to the nonprofit Knowledge Ecology International: Emergent BioSolutions, Catalent, Biological E, GRAM, Aspen and Reig Jofre.

By comparison, production of the AstraZeneca-Oxford vaccine, which uses the same platform technology, involves 21 industry partnerships, according to Public Citizen

Biotech experts stress that sharing the necessary technical know-how in a way that ensures product consistency can be challenging. They underscore how hard it is to crank out new vaccine technologies that have never been made on a massive scale, and they say manufacturing will ramp up with time. 

While Merck can soon begin helping Johnson & Johnson package doses into vials, the company cannot start manufacturing drug substance right away.

In the short term, the addition of Merck’s formulation and filling lines will provide a boost, said consultant John D. Grabenstein, a former Merck Vaccines executive and leader of the Pentagon’s military immunization program, but making the drug will take longer.

“The bulk production that is also uniquely part of that agreement is going to take additional months before it gets traction,” he said.

“It’s common with any new vaccine production for the confidence and the consistency of lot yields and lot successes to rise in the first six and 12 months,” Grabenstein said.

A complex assembly line brings uncertainties. 

Any delay “doesn’t mean there are catastrophic issues,” said consultant Norman Baylor, a former director of FDA’s Office of Vaccines Research and Review. “But it does mean that something ... has delayed that entire manufacturing process to miss the mark.”

A February Government Accountability Office report identified three key bottlenecks in COVID-19 vaccine manufacturing. First, only a few facilities have enough production capacity. Second, vaccine components like reagents are on back order due to global demand. Third, engineers are in short supply. 

The pharmaceutical industry has not traditionally invested in faster manufacturing, said Mark Witcher, a 30-year expert. Witcher previously oversaw manufacturing at Amgen, a Johnson & Johnson competitor. 

The industry typically faces little competitive pressure to make drugs more quickly. Clinical trials usually take years, and companies then enjoy years of patent protection. As a result, advancements in manufacturing typically have not kept pace with advances in medicine.

“That separates the pharmaceutical industry from other industries. They don’t have the competitive forces that fuel the drive for imagination,” Witcher said.