Only days after Pfizer applied for an emergency use authorisation (EUA) for its antiviral Paxlovid from the US Food and Drug Administration (FDA), the company has signed a deal with the US government worth $5.3bn.
The supply agreement will see the government receive ten million treatment courses of Paxlovid, pending regulatory approval, starting later in the year and into 2022.
Paxlovid is a combination of PF-07321332 and ritonavir; PF-07321332 blocks the action of a protease that the coronavirus needs to replicate while ritonavir is an antiretroviral used commonly to treat HIV infections that slows the breakdown of PF-07321332, thereby increasing its duration of action.
While Pfizer only applied for the EUA covering the treatment of mild to moderate COVID-19 in high-risk patients last week, approval is likely, given recently releases data. The EPIC-HR study that showed the drug cut the risk of hospitalisation and death from COVID-19 by 89%.
A phase 2/3 trial, EPIC-HR studied non-hospitalised adult patients with COVID-19 who were at high risk of progressing to severe illness. The 89% reduction in risk of severe COVID-19 (compared to placebo) was seen in patients who were treated within three days of the onset of symptoms.
The whopping $5.3bn price tag for Paxlovid is “based on the principles of advance commitment, volume, equity and affordability”, said Pfizer, a price that was “reflective of the high committed volume of treatment courses being purchased through 2022”.
Pfizer has also entered into advance purchase agreements with several other countries, as well as committing to “equitable access” at an affordable price for poorer countries through a tiered pricing approach based on the income level of each country.
“It is encouraging to see a growing understanding of the valuable role that oral investigational therapies may play in combatting COVID-19, and we look forward to continuing discussions with governments around the world to help ensure broad access for people everywhere,” said Pfizer chairman and CEO, Albert Bourla.
Pfizer has also announced that it and BioNTech have received an expanded EUA for a booster dose of its vaccine, Comirnaty, for people aged 18 and over.
US Food and Drug Administration (FDA) has expanded the EUA of a booster dose of the Pfizer/BioNTech COVID-19 vaccine to include individuals aged 18 and older.
Previously, the vaccine was only permitted as a booster for those aged 65 and over, younger people at higher risk of severe COVID or institutional/occupational exposure and some people who received a different COVID-19 vaccine.