With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.
While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.
Pfizer working on an mRNA flu vaccine
Pfizer began working with BioNTech (NSDQ:BNTX) to develop an mRNA-based flu vaccine in 2018. The mRNA platform could boost flu vaccine efficacy and lead to a better immune response. Traditional flu vaccines are between 40% and 60% effective among the overall population, according to the CDC.
The company aims to launch human trials for a modified RNA flu vaccine in the third quarter of the year.
Delta variant concerns
Pfizer is currently running a clinical trial to test the use of a third dose of its vaccine six to 12 months after full vaccination. That trial will analyze the efficacy of its current vaccine on various SARS-CoV-2 variants.
“Additionally, we have started an evaluation of an updated, prototype variant version of our vaccine that encodes the spike protein of the lineage B.1.351 SARS-CoV-2 variant, which includes the mutation E484K, first identified in South Africa,” said Pfizer CEO Dr. Albert Bourla in the company’s earnings call.
According to a slide deck presented in its Q2 earnings call, Pfizer noted that a third dose of its existing vaccine elevated antibody titers five times for people between 18 and 55. In addition, antibody titers rose 11 fold for those 65 to 85.
Pfizer plans on applying for Emergency Use Authorization as soon as August.
The company is also aiming to launch an immunogenicity and safety study to test a Delta variant–focused version of its vaccine.
Pfizer continuing to optimize vaccine stability
One of the biggest logistical hurdles to administering the Pfizer COVID-19 vaccine in the past was its stringent storage requirements. The company is working to make it easier to transport by optimizing its stability. The company submitted new stability data to the FDA last Friday. As a result, it anticipates that it could “soon receive an update to our EUA prescribing information, allowing the vaccine to be stored at standard refrigerator temperatures of two to eight degrees Celsius for up to four weeks,” Bourla said.
A ready-to-use vaccine formulation would allow the vaccine to be stored at standard refrigerator temperatures for up to 10 weeks if it passes regulatory muster. In addition, the same formulation could be stored for up to six months between –50° and –70°C.
COVID-19 antiviral protease inhibitor
In addition to vaccines, Pfizer continues to develop an antiviral protease inhibitor known as PF-07321332 that will potentially reduce the severity of COVID-19 symptoms when administered early in the case of the disease.
If approved, it would be a first-in-class oral COVID-19 protease inhibitor. A Phase 2/3 trial for the protease inhibitor is underway.
The company anticipates that the product would be prescribed as a 5-day course of treatment after the first sign of infection arises.
Pfizer also believes the therapy could be used for people who come into contact with someone who contracts COVID-19. For that purpose, it is testing 5- and 10-day post-exposure prophylaxis administration of the investigational drug.
Pfizer hopes to file for an EUA for the drug in the fourth quarter of the year. It envisions that hundreds of millions of people could be candidates for the investigational drug.
Filed Under: clinical trials, Drug Discovery, Infectious Disease