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Vaccine makers were just beginning to catch up to demand. Then omicron hit.

Pfizer-BioNTech led its U.S. rivals in 2021 manufacturing, but ultracold freezer requirements make its vaccine harder to ship to remote parts of the world

People wait to receive a coronavirus vaccine at a hospital in Narok, Kenya, in December. (Baz Ratner/Reuters)

The omicron variant is scrambling the outlook for global coronavirus vaccine supply in 2022, increasing pressure on vaccine manufacturers to accelerate production to meet surging demand for booster shots and close the gap between rich and poor nations.

Spiking demand for boosters in wealthy countries — especially for Pfizer-BioNTech and Moderna, which are considered the most effective vaccines — will make it all the more difficult for the global south to catch up to wealthier nations any time soon, advocates and experts said.

And yet the large numbers of people in the developing world who remain unvaccinated make it all the more likely that the coronavirus can mutate and develop new variants, they said.

“We’re already seeing countries change approach to their booster rollout. That takes a toll on current supply,” said Louise Blair, lead analyst at Airfinity, a British consulting firm that closely tracks manufacturing data.

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The pharmaceutical industry trade group, PhRMA, has pointed to overall global supply of vaccines as a sign of international success. As of Jan. 3, 9.2 billion shots have been given worldwide.

But global health experts say far more shots are required.

Giving 70 percent of the world’s 8 billion people two shots will require 11 billion shots. Adding a third shot or booster pushes that target to at least 16 billion shots. Moreover, not all shots provide a strong response, particularly against omicron.

Nearly half of all global vaccinations delivered so far are made by Chinese manufacturers. Those shots — Sinovac and Sinopharm — are proving to be much less effective than Pfizer-BioNTech and Moderna’s mRNA vaccines against the new variant.

Because other shots provide less protection, a consortium of advocates and academics on Wednesday said the world needs 22 billion shots of mRNA vaccines in 2022 to stem the pandemic — a threshold that is not achievable under current projections.

Wealthy nations rush boosters to counter omicron as poorer nations await first doses

“We’re in for a rough road,” said C. Sola Olopade, a physician, dean of academic affairs and director of international programs at the University of Chicago Pritzker School of Medicine. “As long as there is this disparity and inequity in being able to vaccinate the whole world, we all are not going to be safe, because this virus is going to keep mutating and we won’t be able to predict how dangerous the next mutant is going to be.”

Vaccine makers, which developed shots in record time, have registered mixed results in efforts to meet the challenge.

Among U.S. manufacturers, Pfizer produced 3 billion shots and plans to build on its know-how and raw materials advantages to boost supply to 4 billion doses in 2022.

It has committed to selling 1 billion discounted shots to the U.S. government for donation to disadvantaged nations.

The company has said it expected $36 billion in coronavirus vaccine sales in 2021 and $29 billion in 2022, a number that was based on contracts for this year as of mid-October.

Omicron could derail efforts to reverse vaccine inequality and end the pandemic, experts warn

But the challenges of distributing Pfizer’s vaccine in remote areas are significant, said logistics experts.

Its vaccine requires ultracold freezers, making it difficult to transport to rural areas of the developing world that lack hospitals and electricity.

The charitable arm of United Parcel Service, the UPS Foundation, has donated 25 million doses of vaccine to 18 countries, as well as 250 ultracold freezers that keep the Pfizer vaccine at the required negative-90-to-60 degrees Celsius. It also has donated smaller freezer packs that can be placed on trucks for delivery into areas without electricity.

“The biggest problem right now, the biggest point of friction, is the ultracold infrastructure,” said Michael Shiffler, CEO of Red Lightning, a nonprofit logistics operation working with UPS and training health officials on the special handling demands in places such as Malawi and Indonesia.

About 30 percent of the fully vaccinated in the U.S. have gotten boosted. Omicron could speed things up.

“Pfizer is really critical right now because of the sheer volume it is producing,” he said. “But if you want to store Pfizer for any given period of time, you need to have ultracold storage. And the vast majority of African countries do not have ultracold freezers.”

Moderna and Johnson & Johnson have shots better suited for rigorous conditions, but those companies wrapped up 2021 well short of their publicly stated production goals.

Moderna downgraded its 2021 production goal to 700 million to 800 million from 1 billion. While most of Moderna’s supply has been sold to wealthy countries, it has struck deals to deliver more vaccine to the developing world via the Covax international collaborative in 2022.

Moderna never sold a product before its coronavirus vaccine. It has said it expects to post $15 billion to $18 billion in vaccine sales for 2021.

The company has faced intense political criticism for not doing more to supply vaccine for the world, despite its taxpayer subsidies and partnership with the government. The company has resisted repeated calls to share its technology with developing nations so its vaccine could be produced outside of its own limited production line. It also has disputed U.S. government patent rights to its vaccine, even though it worked closely with National Institutes of Health scientists to invent key ingredients. That dispute is currently on pause.

The company has not provided explanations for why its production plateaued in late spring of 2021, while Pfizer ramped up much faster to a larger volume. Moderna, a start-up biotech company with no major manufacturing experience, has relied on a contract manufacturer, Lonza, to make much of its vaccine. Pfizer has leveraged its deep experience and multinational footprint to accelerate, including making its own raw materials.

According to Moderna’s disclosures in public reports to shareholders, its shipments leveled off last spring at an average of about 68 million doses per month.

Moderna focused primarily on sales to the wealthiest nations that could afford higher prices, said James Krellenstein, a co-founder of the advocacy group PrEP4All that has urged the United States to exercise its rights or leverage the Defense Production Act to produce its own version of Moderna’s vaccine.

“This is just plain old market failure,” he said. Activists and some Democrats in Congress have expressed frustration that the Biden administration has not taken a more forceful stance with regard to Moderna’s production.

Moderna said it plans to dramatically boost production in 2022, to between 2 billion and 3 billion doses. It also has pledged to enter into agreements for sales of vaccine to Covax, the international effort to distribute vaccines to low-income countries, as well as a consortium of African countries. And it said last year that it will build a vaccine factory in Africa in the future.

The company did not directly address questions about why its production plateaued in 2021 but did allude to its relatively small size.

“In less than a year after the pandemic’s onset, Moderna’s team of approximately 2,400 employees was able to mobilize the Company’s existing mRNA platform to develop, test, and manufacture an authorized, safe and effective coronavirus vaccine,” the company said in response to written questions.

Global vaccine inequality runs deep. Some countries say intellectual property rights are part of the problem.

“People are dying, time is of the essence, and in the midst of it all, Moderna is making billions of dollars — controlling vaccine production and negotiations of a lifesaving vaccine that HHS helped them to create,” Rep. Rosa L. DeLauro (D-Conn.), chairwoman of the House Appropriations Committee, said in a November hearing.

Biden’s Department of Health and Human Services did not respond to requests for comment. The administration is asking drug companies to submit proposals this year to build manufacturing capacity for mRNA vaccines that would be dedicated for government supply and used to meet the administration’s public policy goals.

Biden’s top vaccine science adviser, David Kessler, has said the administration has taken a forceful stance in dealings with Moderna.

Baltimore plant with contaminated Johnson & Johnson vaccines had multiple failures, unsanitary conditions, FDA says

Johnson & Johnson has faced problems on two sides, one on safety and the other on manufacturing.

The Centers for Disease Control and Prevention said last month that Americans should view the mRNA vaccines as preferable because of the extremely rare risk of dangerous blood clots with the Johnson & Johnson shots. The company has said it remains confident in the benefit-risk profile of its vaccine. The company on Dec. 30 announced clinical trial results from South Africa that showed a second shot provided 85 percent protection against hospitalization after omicron had become the dominant variant.

Johnson & Johnson also encountered crippling manufacturing problems and delayed the projected time it will reach an annual production rate of 1 billion doses to an unspecified time in 2022.

Its government-backed contract manufacturer in the United States, Emergent, endured a months-long crisis in its Baltimore production facility when it contaminated Johnson & Johnson vaccine with ingredients from AstraZeneca’s vaccine, which was being made in the same facility. Without blanket FDA manufacturing approval for the site, the government has been approving doses batch by batch, with 120 million shots released so far, the vast majority of it Johnson & Johnson vaccine, Emergent said this week.

Johnson & Johnson’s manufacturing partnership with Merck, which was brokered by the Biden administration last spring, was supposed to result in doses late last year but is now expected to begin producing significant volumes of vaccine in the spring, according to administration officials.

Johnson & Johnson’s vaccine has accounted for a tiny percentage of doses administered in the United States: 17.7 million compared with nearly 500 million between Pfizer-BioNTech and Moderna, according to the latest data from the CDC.

Novavax, meanwhile, an untested small biotech company with a highly anticipated vaccine, has encountered delays in clinical trials and manufacturing. Eighteen months after the company was backed by President Donald Trump’s Operation Warp Speed, it has yet to submit its application to the Food and Drug Administration for emergency use authorization.

Last month, it received clearance from the European Union, the World Health Organization, and India, paving the way for a promised production surge in 2022, with most coming from a contract factory in India.

“Overall, we expect to achieve an excess of 2 billion doses in 2022,” John Trizzino, Novavax chief commercial and business officer, said in an emailed statement.

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