Vaccine supplies are swelling and more and more independents are receiving doses through state allocations or through the Federal Retail Pharmacy Program. AmerisourceBergen, our wholesale partner, is now allocating vaccine in 29 states in the federal program, up from 10 states last week.
On March 15, CMS announced that it had increased the administrative fee paid to COVID vaccinators to $40 for each dose in Medicare and Medicaid. The former rate was $16.94 for the first dose in a two-dose series and $28.39 for a second dose or for a single-dose vaccine. The increase is good news for vaccinating pharmacies, whose expenses in labor, PPE and syringes have sometimes been significant.
Important News
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AstraZeneca/Oxford Monday released its Phase III trial data on Monday, announcing that its two-dose vaccine is 79% effective against symptomatic infection. But AZ revised that number to 76% late Wednesday after the independent Data and Safety Monitoring Board took issue with the use of now-outdated data to promote the vaccine's benefits. J&J says it is on track to submit its application to the FDA sometime in the first half of April. You should expect AZ's application to receive extra scrutiny after all its well-publicized issues.
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After months of struggling to get enough vaccine doses to eager immunizers, the federal government is now looking at the nation's vaccine supply outstripping demand by May 1. President Biden has promised enough doses by the end of May to immunize all of the nation’s 260 million adults. But the government has locked in commitments from May to July to buy vaccine to cover 400 million people — 70 million more than the U.S. population. Whether to keep, modify or redirect those orders is a complicated question. The feds say say they intend to send 4 million doses of the AZ vaccine to Canada and Mexico.
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The CDC has issued revised clinical recommendations on dosage intervals for the Pfizer and Moderna vaccines. Intervals of 6 weeks between COVID-19 vaccine doses are acceptable IF delays are unavoidable, the CDC says, but it stressed that the Pfizer and Moderna vaccines are not interchangeable, barring exceptional circumstances.
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The FDA has updated the labeling for the Pfizer–BioNTech vaccine to allow the use of needles or syringes with low dead volume to extract a sixth dose from the vials. Using standard needles or syringes, a vial yields only 5 doses.
Vaccine-Specific Updates
Pfizer
Last month, Pfizer announced a study to develop a booster for the B.1.351 variant first identified in South Africa. The company also initiated a trial specifically for pregnant women. On March 25, Pfizer launched a global study of 144 participants to determine if the vaccine can generate an immune response in children in three age groups: 6 months to 2 years; 2 years to 5 years; and 5 years to 11 years.
Moderna
Moderna began a Phase 1 trial this month of a vaccine made specifically for the B.1.351 variant and a Phase 1 trial of a new, refrigerator-stable vaccine.
Janssen
As previously reported, J&J launched a second Phase 3 trial to observe the effects of two doses of its vaccine. The results are expected in late 2021. Last month, J&J launched a trial for pregnant women and this month announced it would soon start trials on children. J&J says it could have a vaccine for children ready by September.
AmerisourceBergen Readiness Updates for Vaccine Applicants
As ABC increases vaccine shipments to more member pharmacies in more states, it is ramping up up its certification and communication outreach to make sure that no willing vaccine participant is excluded. ABC says there are approximately 400 member pharmacies nationwide that have applied for vaccine certification but are still not ready. These participants could be missing one or more readiness steps -- such as completing the mandatory CDC training or signing up with their state vaccine registry. It has so far been a cumbersome manual process to communicate with these pharmacies about their outstanding readiness requirements
Effective March 26, ABC will send weekly automated direct emails to pharmacies with specific details on what that eligibility requirements that pharmacy lacks to receive vaccine allocations when they are available:
- Emails will be sent every Friday evening to program participants missing one or more readiness requirements.
- The emails will be based on up-to-date Hub data, which now includes data points for each readiness requirement (found in the subscriptions area under the Program Master).
- Each email will be sent to a specific participant under pharmacy name and NCPDP.
- Emails will be sent to primary AND secondary contacts (unless the secondary is the same email address as the primary).
- The emails will only communicate what that particular participant needs to do to become eligible for vaccine allocation.
- Vaccine applicants that have not met all requirements will continue to get weekly emails until they:
- complete all readiness requirements and/or
- ask that their pharmacy be put on hold or terminated from the program.
APRx strongly urges all member pharmacies that have applied to receive COVID vaccine from our wholesaler to be sure they have completed ALL ABC's requirements. You will not be eligible to receive vaccine until you complete ALL the requirements.
The three steps that many enrolling pharmacies are not completing after signing up with ABC/GNP as immunizers are:
