The effort to combat COVID-19 appeared to take two important steps this week.
On Monday, Pfizer and the German company BioNTech announced an early analysis of their COVID-19 vaccine candidate showed 90% fewer symptomatic cases in the group who received the vaccine compared with those who received the placebo. The companies expect to have enough efficacy data compiled by mid-to-late November to be able to apply for an emergency use authorization (EUA) from the Food and Drug Administration (FDA), according to a joint press release.
The two companies expect to produce up to 50 million vaccine doses in 2020 and 1.3 billion in 2021, the release said.
Meanwhile, the U.S. Health and Human Services (HHS) Department announced Wednesday that it will allocate Eli Lilly and Co.’s investigational monoclonal antibody therapeutic, bamlanivimab, for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. Bamlanivimab is administered intravenously to adults and older children whose COVID-19 progression is likely to be severe, according to the FDA.
The announcement came after Lilly obtained an EUA on Tuesday.
An EUA allows for certain medical products to be used in an emergency to diagnose, treat, or prevent life-threatening diseases like COVID-19 when there are no other alternatives, according to FDA. It is not equivalent to FDA approval but allows the product to be used while it goes under further analysis.
The Texas Department of State Health Services (DSHS) has said COVID-19 vaccines will be distributed in four phases:
- Phase 1 – Limited access to the vaccine means few people – mainly targeted health care and emergency workers – receive doses.
- Phase 2 – Broader access allows wider distribution to priority groups and to other parts of the public.
- Phase 3 – Excess supply allows for broad vaccination.
- Phase 4 – Vaccination becomes routine.
However, the speed of distribution will depend on the national supply, and it remains unclear how fast the state will reach each phase, according to DSHS.
DSHS has established a panel of 16 Texas lawmakers, officials, and physicians – including seven TMA members – to advise DSHS on the details of distributing COVID-19 vaccines. TMA Director of Public Health Christina Ly, PhD, also serves as a consultant.
The U.S. government plans to purchase 300,000 doses of bamlanivimab and distribute them to the states, HHS said in its release. The states in turn will determine which health care facilities will receive the drug, HHS said. The federal government can purchase up to 650,000 additional doses if needed through June 30, 2021, for distribution across the country.
Distribution of bamlanivimab in Texas will be handled in a way similar to the distribution of the COVID-19 medication remdesivir, according to Chris Van Deusen, DSHS spokesperson.
Both medications may present logistical problems for physicians and other health care professionals.
For instance, the Pfizer vaccine will require special ultra-cold refrigeration equipment to be stored, the company notes in its release. Most medical practices and smaller hospitals do not have that type of infrastructure.
Bamlanivimab also presents challenges because it is an infusion drug, the HHS press release says.
“To accommodate IV infusions, outpatient facilities must have appropriate health care staffing, training and equipment,” the release said. “Additional preparation time may be required for some treatment facilities before they can administer the treatment to patients.”
Find more tools, resources, and information on TMA’s COVID-19 Resource Center, which is continually updated.