Covid-19 items from Pfizer's recent Q2 earnings call...
1) Will apply for EUA (emergency use authorization) on booster dose.
2) Will start an immunogenicity and safety study on updated vaccine for the Delta variant.
3) Have started Phase 2/3 trial of orally administrated protease inhibitor treatment drug.
Pfizer (PFE) Q2 2021 Earnings Call Transcript
fool.com
Jul 28, 2021, 10:00 a.m. ET
We now turn to our COVID-19 vaccine program in collaboration with BioNTech. The Delta variant, which is the most transmissible we have yet seen, is expanding rapidly worldwide and now represent approximately 83% of sequence cases in the US We continue to believe it is likely that the third dose booster may be needed within six to 12 months after full vaccination to maintain the highest level of protection. And studies are underway to evaluate the safety and immunogenicity of a third dose. We are in ongoing discussion with regulatory agencies regarding a potential third dose boost of current vaccines, and assuming positive results, anticipate an emergency use authorization submission as early as August.
Pending regulatory approval, we'll also plan to start an immunogenicity and safety study in August to evaluate an updated version of our vaccine, specifically designed to target the Delta variant. Here, we show initial data from a small number of patients receiving a third dose of existing vaccine. We observed a significant boost in utilizing antibodies following a third dose of the current vaccine for both wild type and the Beta variant. At eighht months post dose two, antibody levels start to decline from earlier peak.
In our initial analysis, a third dose given more than six months after the second dose elicited neutralizing antibodies, which are more than five times higher than the wild type and more than 10 times higher against the Beta variant than of the two primary doses. The third dose elevates the neutralizing antibodies in our laboratory studies up to 100x higher levels post dose three compared to pre-dose three. Just as we saw in the analysis of neutralizing antibodies from those in the original phase three trials, the levels in the older population were comparable to the younger population. Here, we show new breaking data from a small number of participants that the third dose boost with the current vaccine elicited neutralizing titers that when tested against the Delta variant were more than fivefold post dose two in younger people and more than 11-fold post dose two in older people.
Receiving a third dose more than six months of the vaccination, when protection may be beginning to wane, was estimated to potentially boost the neutralizing antibody titers in participants in this study to up 100 times higher post dose three compared to pre-dose three. These preliminary data are very encouraging as Delta continues to spread.
Finally, let's turn to our potentially first-in-class COVID-19 antiviral protease inhibitor. If successful, our protease inhibitor has the potential to provide patients infected with COVID-19 with a new oral therapy that could be prescribed for a five-day treatment course at the first sign of infection before patients are hospitalized or in critical care.
For patients who are in close contact with someone who contracts COVID-19, we will study both five and 10-day post-exposure prophylaxis courses. The goal is to reduce SARS-CoV-2 viral load, thereby hopefully decreasing or preventing symptoms of COVID-19 and minimizing the risk of hospitalization. In July, we initiated a Phase 2/3 trial to evaluate the efficacy, safety and tolerability of the orally administrated protease inhibitor in participant with COVID-19. If successful, we project a potential US Emergency Use Authorization submission in the fourth quarter.
Our protease inhibitor exhibits potent, selective in vitro antiviral activity against SARS-CoV-2 and other coronaviruses and potentially all currently known COVID-19 variants. It also has demonstrated a robust preclinical antiviral effect on cells and in SARS-CoV-2 infected animals, enabled by selectivity that is more than 100 times higher for coronavirus 3CL proteases than human proteases. The chart on the left shows robust dose-dependent reductions in disease microscopical scores in mice. In phase one human studies today, we have seen desirable drug exposure, good tolerability and no safety findings up to a dose of 500 milligrams twice a day over 10 days in healthy volunteers.
The chart on the right of the phase one pharmacokinetic study shows high drug exposure over the entire treatment period, exceeding greater than five times exposure predicted to inhibit SARS-CoV-2 viral replication. This concludes our review of eight selected breakthrough programs among many more to come this decade. Now, let me turn it over to Frank. |
