Supply Chain Snags Blamed For Cut to Pfizer COVID-19 Vaccine Rollout This Year: Report

Pfizer and BioNTech expect to ship only half of the 100 million doses of COVID-19 vaccine they had originally targeted for worldwide delivery this year because of hurdles encountered with the supply chain, according to a report in The Wall Street Journal on Thursday. A person directly involved in the development of the mRNA-based BNT162b2 candidate said “some early batches of the raw materials failed to meet the standards. We fixed it, but ran out of time to meet this year’s projected shipments.”

However, Pfizer and BioNTech maintain that they are on track to roll out 1.3 billion vaccines in 2021, while the 50-million dose shortfall this year will be covered as production ramps up, The Wall Street Journal said. UK regulators granted the first emergency-use authorization for BNT162b2 earlier this week. The two-dose vaccine is also under review for emergency use in the US, with an FDA advisory panel scheduled to meet to discuss the filing on December 10. Results from a recent analysis demonstrated that BNT162b2 has an efficacy rate of 95% based on 170 cases of COVID-19 seen in a phase 3 study of 44,000 participants.

Delay in scaling up raw materials

The companies said in July that they would manufacture up to 100 million doses of BNT162b2 globally before year-end, with The Wall Street Journal noting that the target remained in place until around mid-November, when it became clear the supply chain problems were too great to meet that timeline. Pfizer and BioNTech cut the delivery projections to 50 million doses on November 9 when they reported interim data for the vaccine. “Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said, “and it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

Pfizer, which sources its raw materials from providers in the US and Europe, would not disclose where shortfalls over ingredients arose as it ramped up production, although The Wall Street Journal report noted that the drugmaker has never manufactured a vaccine with technology that uses mRNA. “For this one, everything happened simultaneously…We started setting up the supply chain in March, while the vaccine was still being developed. That’s totally unprecedented,” the person familiar with the development said.

Millions of doses already ordered

The drugmaker is setting up what it has described as its largest ever vaccination campaign through two final assembly and distribution centers based in Kalamazoo, Michigan, and in Puurs, Belgium, which will handle the European supply. The US government has agreed to pay nearly $2 billion for an initial order of 100 million doses of BNT162b2, with an option to acquire up to 500 million more. Moncef Slaoui, chief advisor overseeing the Trump administration’s Operation Warp Speed initiative, said there is no change to Pfizer’s vaccine commitment to the US, and he estimated earlier this week that 20 million Americans would be immunised against the novel coronavirus by the end of this year. The FDA is also evaluating Moderna’s COVID-19 vaccine candidate mRNA-1273.

Meanwhile, last month, the EU ordered 200 million doses of BNT162b2 with an option for another 100 million, while the UK has a supply deal for 40 million doses of the vaccine. Japan has reserved 120 million doses, and countries in South America and in the Asia-Pacific region have also placed significant orders for Pfizer and BioNTech’s candidate.