Saturday, May 15, 2021
Original post can be found on the Duke Global Health Innovation Center's Launch and Scale Speedometer website.
What the manufacturing landscape can tell us now
Author: Andrea Taylor
Manufacturing projections for Covid-19 vaccines seem to shift on a near-weekly basis. We are not even halfway into 2021 and already we have seen adjustments, both up and down, across all vaccine makers.
2021 projections differ by vaccine platform
Overall, we see 2021 projections increasing for mRNA vaccines Pfizer-BioNTech and Moderna, while decreasing for viral vector vaccines Oxford-AstraZeneca and Janssen (J&J). AstraZeneca, in particular, has faced significant manufacturing issues throughout its global production network. In addition to the well-covered constraints slowing down manufacturing in Europe and the Serum Institute of India, partners in Mexico, Brazil, and elsewhere have struggled to get production started or sustained.
Janssen’s vaccine has also experienced setbacks, including the temporary closure of the Emergent BioSolutions plant in the US after up to 15 million doses were discarded due to an error in production. Merk is signed up to help with production but not until September at the earliest. White House officials told state governors this week that there were no available doses of J&J vaccine to order. The CEO recently punted when asked if the company could still meet its 2021 goal of 1 billion doses, saying only that they would be able to meet their current contractual obligations.
Novavax, using a protein subunity platform, has also experienced delay after delay in their 2021 production. Like AstraZeneca, the company lacked in-house manufacturing and had to build a global network of manufacturing partners. Scaling these partners has been slowed by the global shortage of supplies needed for production, such as filters and bioreactor bags. This week, Novavax announced further delays to their manufacturing projections, now expecting to reach 150 million doses per month by the end of the year.
|Platform||Vaccine||2021 Projections||2022 Projections|
|Inactivated virus||Bharat Biotech||unknown||150,000,000||494,200,000||700,000,000|
Looking at the projection trendlines, it appears that mRNA vaccines will be able to scale faster and more reliably this year. That is likely due to a few factors. The mRNA vaccines were the first to the global market and thus had a jump start on other Covid-19 vaccines in working through teething problems as they expanded production.
The mRNA vaccine makers have also used a more centralized production approach, likely out of necessity as there are very few manufacturing partners with mRNA capabilities. This may also have given them an early advantage in reaching scale. The production networks for Pfizer-BioNTech and Moderna are tightly centered in the US and Europe and largely kept in-house. They did not have to invest time into getting 10 or 15 technology transfers off the ground, like AstraZeneca or Novavax.
The production process for mRNA vaccine is also faster than for traditional vaccine platforms. Pfizer-BioNTech’s mRNA vaccine can be produced from start to finish in about 2 months. By contrast, each batch of viral vector, inactivated virus, and protein subunit vaccines can take more than 3 months to produce if all goes perfectly. Yields for the drug substance for these vaccines are somewhat unpredictable and batch issues can set the process back by months. So although mRNA vaccine makers faced challenges with new technology and a dearth of partners, they appear to have the advantage this year.
2022 is looking good for vaccine production all around
The projections for 2022 are astounding. Western-based Covid-19 vaccines project 14.5 billion doses in 2022 (representing 8.5 billion people who can be vaccinated, given that J&J is one dose). We anticipate that there will be bumps along the way and these numbers (just as in 2021) will shift. Some discounting is probably wise, given the 2021 experience so far. But we have more confidence in these numbers than we did in the early 2021 projections.
We do not yet have credible projections for Russia-made vaccine manufacturing in 2022 but Chinese and Indian vaccine makers expect to produce another 4.2 billion doses next year, for a possible global total of 18.7 billion doses in 2022.
Since much of the world will still be waiting for vaccinations by 2022, this is definitely good news. It also indicates that there will be room for annual booster production without compromising access to first-round vaccinations globally. The key questions will be whether we can prevent devastating surges while we wait, make sure doses actually get to every country, and adequately address vaccine hesitancy.
Significant updates, news, and trends we saw last week:
- The US FDA expanded emergency use authorization for the Pfizer-BioNTech vaccine to include children ages 12 and older.
- US supply appears to be outpacing demand, with states reducing orders from the federal government and turning to lottery models to further increase vaccination rates.
- As the US vaccine drive slows down, the EU rollout is finally speeding up.
- Europe and Australia, having initially bet heavily on Oxford-AstraZeneca, are now swinging away and working to replace it with other vaccines for national supply.
- The Independent Panel for Pandemic Preparedness and Response released their findings and recommendations this week, which include our data and analysis.
- Serious questions were raised in the Lancet this week about the Sputnik V Phase 1/2 trial data, as well as availability of data from the Phase 3 trials and the trial protocols.
- WHO labeled the Indian variant “of global concern” this week. It is too early yet to assess how it responds to current vaccines.
- Seychelles has the highest rate of vaccinations in the world but is now seeing high rates of infection, including among the vaccinated.
- Novavax has delayed plans to complete applications for regulatory approval in the US, UK, and Europe until end of September.
For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.