Novavax and J&J with Vaccine Delivery Delays

09.02.2022 - As wealthy countries with ample supplies of Covid-19 vaccine struggle to convince more people to get the shot, and poorer countries struggle to nail down supplies, two US vaccine makers are making negative headlines. While EU and UK approval of the Novavax vaccine was just celebrated with fanfare, that company as well as Johnson & Johnson is now said to face delivery delays.

Sources speaking to the Reuters news agency said Novavax will be unable to supply its contingent of doses promised to Europe for the first quarter. Separately, the New York Times reported that J&J late last year “quietly shuttered” a plant in the Netherlands, potentially reducing its supply potential by “a few hundred million doses.”

J&J has reportedly hired toll manufacturers to help bridge the gap but these have not yet received regulatory clearance. In the meantime, “people familiar with the matter” told the Times that the facility is instead focused on making a “different, possibly more profitable” vaccine aimed at a non-Covid virus.

The delivery delays at the two companies are troubling as they mirror the glitches that occurred in Europe in the early vaccine rollout stages of 2021. At the time, the shortfall led to heated verbal exchanges between “have and have not” countries.

As regards Novavax, Reuters said it was told that shipments to the EU, Indonesia and the Philippines were held back by a late regulatory approval from the World Health Organization (WHO) and export limitations of its production partner, the Serum Institute of India, in addition to delayed approval of individual vaccine batches by European regulators.

The setbacks have led at least one country to reconsider its Novavax order, Reuters’ sources said, adding that the Maryland biotech has delivered only a small fraction of the 2 billion Covid-19 doses it plans to ship around the world during 2022. Indonesia has received around 10 million vaccine doses, Australia and New Zealand several million, Novavax told the news agency.

Delivery delays to Covax especially worrying

It is seen as especially worrying that Novavax (which has never had a commercial product) has not yet delivered any of the 1.1 billion doses promised to Covax, the global vaccine distribution program for poorer countries. The company now says it expects to deliver around 80 million doses to Covax before the end of the first quarter. According to published Refinitiv data, the US company is expected to earn around $5 billion from Covid-19 vaccine sales in 2022.

Novavax’s European delay is being blamed on a holdup of the doses made by the Serum Institute, which are awaiting final regulatory clearance at a distribution facility in the Netherlands. According to one report, the biotech has not yet provided sufficient information about the batches produced in India, where all EU supplies are originating.

J&J’s delays have created unease in the African Union, though the company told the Times it was continuing to supply facilities that handle fill & finish and, moreover, has “millions of finished doses” in inventory. The J&J product has fallen out of favor in the US and Europe because of blood-clotting issues but its single-dose regime is popular in companies without an adequate distribution as it does not require ultracold refrigeration.

Author: Dede Williams, Freelance Journalist