One slide lays out Pfizer's busy 2021 plans for its COVID-19 vaccine, including when it could start being used in kids

  • Pfizer outlined Tuesday a busy 2021 for its COVID-19 vaccine.
  • The drugmaker expects to apply for full US approval in May.
  • Additional studies are testing a temperature-stable version and giving it to younger children.
  • See more stories on Insider’s business page.

Pfizer outlined a busy 2021 for its coronavirus vaccine on Tuesday, as executives for the drugmaker projected the shot will bring in $26 billion in revenues on the year. 

Even though the shot is already authorized in the US and elsewhere, there’s tons of research going on to expand the vaccine’s impact. In particular, Pfizer is studying the vaccine in children of all ages, going all the way down to babies. The company also expects to have data this year for a new version of its shot that doesn’t need to kept at any unusually low temperatures.

Pfizer’s shot, co-developed with the German biotech BioNTech, was the first COVID-19 vaccine authorized in the US. More than 130 million doses have been administered in the US so far, according to the Centers for Disease Control and Prevention. 

One slide in Pfizer’s earnings presentation on Tuesday summarizes the cascade of news the New York pharmaceutical giant expects over the next few months:

Gearing up for more authorizations through the end of 2021

In May, Pfizer plans to submit for full approval in the US.

Currently, regulators issued an emergency use authorization (EUA) for the shot. Full approval would give Pfizer more ability to market and promote its vaccine, and some organizations could also feel more confident in requiring the shot once it’s fully approved.

Pfizer also expects to launch a new study in May, in which the COVID-19 vaccine is given alongside its experimental pneumococcal conjugate vaccine. The pneumococcal vaccine is under FDA review and is expected to make an approval decision by June.

The summer will bring another flurry of updates for Pfizer’s vaccine. The company plans to apply for an emergency OK for its vaccine as a booster shot, and also produce data in August for a new version of the vaccine that could be stable for up to 10 weeks with just typical refrigeration.

The cold-storage requirements were an initial challenge facing Pfizer’s shot, although newer data shows the current vaccine is stable with normal refrigeration for up to four weeks. 

Finally, Pfizer is hoping it will be able to roll out its vaccine into the pediatric population throughout 2021. The company is currently waiting on an FDA decision to OK the shot for ages 12-15. The vaccine is currently authorized for use in anyone 16 years old and up. 

In September, Pfizer anticipates clinical trial results showing whether or not the shot works in children aged 2-11. The final step down for kids — from 6-month-old babies to 2-year-olds — should produce data in November, according to Pfizer’s projections.

A picture of a switch and lightbulb
Source: Read Full Article