Pfizer lays out timeline for its COVID-19 vaccine and a new flu vaccine

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Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Vial of Pfizer’s COVID-19 vaccine

Photo: Arne Müseler via Flickr

In a teleconference announcing the company’s first-quarter 2021 earnings earlier this month, Pfizer laid out its timeline for when different versions of its COVID-19 vaccine may become available for various populations. The company also said it is working on two approaches for an mRNA-based flu vaccine (similar technology as the COVID-19 vaccine), with plans to run clinical trials in the third quarter.

By the end of May, the New York City company expects to submit a biologics license application (BLA) asking the FDA to fully approve the vaccine rather than continue its use under an emergency use authorization (EUA).

However, the most interesting information relevant to consumers was news of near-term potential milestones for certain populations to be able to receive the COVID-19 vaccine. The company also said it anticipates FDA authorization under an EUA to administer it for pregnant women and children under age 12.

In July, Pfizer expects to have initial findings from its study of a COVID-19 booster shot and apply for FDA authorization by the end of that month. Safety data from a current phase 2 randomized controlled study of pregnant women receiving the COVID-19 vaccine should come around the end of July or the beginning of August.

September is the big month many parents are waiting for. Pfizer’s current trajectory expects to have data from the vaccine trials on children ages 2–5 and in children ages 5–11 in early September and submit an EUA application for both age groups then. Currently, children ages 6 months tp 2 years, 2–5 years and 5–11 years are in phase 1 trials that are testing three different doses of the vaccine: 10, 20 and 30 micrograms. If this schedule holds and Pfizer requests the authorization in early September, that could mean vaccines for all school-age children may be available as soon as late September or early October, depending on how long it takes the FDA to issue a decision.

Data from a trial that administers the pneumonia and COVID-19 vaccines together should become available in late September. The year will wrap up with data from the last children’s trial — 6 months to 2 years old — in November. Ideally, by December, a COVID-19 vaccine should be available for every age group over 6 months old.

The company also is starting a trial to study co-administration to older adults of the COVID-19 vaccine with its pneumococcal vaccine. If the study reveals that it’s safe and effective to give people both vaccines at the same time, it becomes far easier to protect more people from both diseases.

Pfizer, which said earnings from its current Pfizer-BioNTech vaccine were $3.5 billion in the first quarter, projected approximately $26 billion earnings from it in 2021 based on current contracts in the US and globally.

The company anticipates manufacturing a total of 2.5 billion doses in 2021 and 3 billion doses in 2022.

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