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COVID-19 vaccines

Johnson & Johnson Prepares for Regulatory Filings and Global Rollout of COVID-19 Vaccine

Strategic Insights

— 2 min read

As the world anxiously awaits Johnson & Johnson's phase 3 COVID-19 vaccine data, the company is gearing up for regulatory filings and a global rollout. With orders for hundreds of millions of doses pending, J&J executives have expressed confidence in meeting their 2021 supply commitments. The one-dose vaccine would provide a significant boost to worldwide vaccination efforts, as shots from Pfizer/BioNTech, Moderna, and AstraZeneca are still in the early stages of their rollouts. News of supply disruptions for the AstraZeneca and Pfizer vaccines has been emerging in Europe, and U.S. rollouts for the mRNA vaccines have gotten off to a slower-than-expected start. If the data from J&J's vaccine are positive, it could "meaningfully accelerate the rollout of vaccinations across the U.S." and potentially disrupt other vaccine manufacturers' demand expectations.

Key Takeaways:

  • J&J expects to report phase 3 data for its one-dose vaccine by early next week, which could accelerate the rollout of vaccinations across the U.S.
  • The company is "comfortable" meeting its 2021 supply commitments, despite rivals facing manufacturing and logistics hurdles.
  • J&J's vaccine has a one-dose advantage, can be stored at refrigerated temperatures for up to three months, and will be shipped in a five-dose vial that doesn't require dilution.
  • The company has agreed to supply 100 million doses to the U.S., 200 million to Europe, and 100 million to developing countries through Gavi, the Vaccine Alliance, with options for hundreds of millions of additional doses.
  • J&J is planning to onboard seven factories by the end of next quarter to meet its U.S. dose commitment by the end of June and fulfill its European order by the end of the year.
  • The company is testing a two-dose regimen of the vaccine, with results expected later this year.
  • J&J is on track to produce around 1 billion doses of the vaccine during 2021, but did not provide financial guidance for the shot due to the uncertainty surrounding the pandemic.

Statistics:

  • J&J expects to report phase 3 data for its one-dose vaccine by early next week.
  • The company has pledged to supply 100 million doses to the U.S., 200 million to Europe, and 100 million to developing countries through Gavi, the Vaccine Alliance.
  • J&J is planning to onboard seven factories by the end of next quarter to meet its U.S. dose commitment by the end of June.
  • The company expects to produce around 1 billion doses of the vaccine during 2021.
  • J&J's vaccine can be stored at refrigerated temperatures for up to three months.
  • The mRNA shots from Pfizer and Moderna require deep-freeze temps as low as 94 degrees below zero Fahrenheit.

Sources:

  • FiercePharma (https://www.fiercepharma.com/pharma/j-j-scores-1b-contract-from-u-s-to-deliver-100-million-coronavirus-vaccine-doses)
  • CNBC (https://twitter.com/CNBC/status/1354086945840914432)
  • FierceBiotech (https://www.fiercebiotech.com/biotech/johnson-johnson-s-closely-watched-single-shot-covid-vaccine-data-out-next-week-as-cfo-sees)

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