After federal health regulators approved the COVID-19 vaccine for use on Tuesday, the Biden administration is advising states to get ready for a “limited supply” of the doses to be made available.
States probably won’t be allowed to make their initial shipping requests until the following week.
According to a planning document released this week by the Centers for Disease Control and Prevention, “a limited quantity of doses of Novavax COVID-19 vaccine will be delivered and not all providers are expected to have Novavax COVID-19 vaccine.”
The document “tentatively” predicts that states won’t be able to start placing orders from the Biden administration’s stock of Novavax’s vaccine until the week of July 25.
This could mean that, contrary to a previously proposed timeframe by health authorities, the first doses of Novavax’s vaccine won’t reach pharmacies and doctor’s offices until August.
Multiple efforts for comment from Department of Health and Human Services spokespeople went unanswered.
Why is the vaccination program being delayed?
The government’s strategy for distributing Novavax’s vaccine differs from high-profile initiatives to fast spread earlier brands like Pfizer-BioNTech or Moderna.
Shipments for the bullets started a few days after they were officially authorized.
The quality testing that is still happening to clear the company’s shots is just now coming to an end, which appears to be the cause of at least some of the delay in distributing Novavax’s doses.
The Food and Drug Administration recently approved the quality of Novavax’s first vaccination lot, approving its release, the company stated in a statement.
The business stated: “Novavax anticipates shipping doses to the U.S. Government-designated distribution site in the upcoming days.”
Who will be able to receive the vaccine and how much will be made available?
Health authorities will be able to order about three million doses of the Novavax vaccine in total.
In order to meet predicted demand from unvaccinated patients, the Biden administration has pushed states to allocate doses from their “one-time” supply to doctors.
The CDC estimates that approximately 26 million individuals in the United States, or 1 in 10 of the adult population, have not yet received at least one dose of the COVID-19 vaccination.
According to a CDC poll, 16% of those individuals who are unvaccinated said they would “probably” or “certainly” become vaccinated if a protein-based vaccine like Novavax was available.
States are advised to make plans to re-distribute the doses in a way that minimizes wasting the vaccine’s limited supplies, which are available in 10-dose vials that must be used within 6 hours after opening.
The CDC advises that physicians “should not miss any opportunity to vaccinate every eligible person” who requests a shot, albeit this may result in wasting numerous additional doses in the vial as with previous vaccinations.
At a meeting of the CDC’s advisors on Tuesday, Novavax’s Filip Dubovsky stated, “We are working hard to acquire a reduced format of presentations that we can submit to the regulators and get permission in due course.”
Where can I purchase it from?
It’s unclear how the Biden administration will distribute those initial vaccine batches from Novavax across the states and other federal immunization channels like pharmacies or health facilities.
For instance, according to the CDC, the COVID-19 vaccine campaign received more over 250 million doses through the beginning of July through its federal retail pharmacy program.
However, a representative for at least one program member, CVS, stated that the company has “no immediate plans to offer the Novavax vaccination at our retail locations.”
Patients still have easy access to the Moderna and Pfizer COVID-19 vaccines, according to CVS spokesperson Matt Blanchette.
What caused the earlier delays, exactly?
It has been more than six weeks since Novavax’s injections earned the nearly universal support of the FDA’s independent vaccine advisors, and this timeframe represents the most recent delay in the vaccine’s availability to unvaccinated adults.
The FDA did not approve the company’s injections for emergency use until July 13.
According to documents released this week by the FDA, discussions with the agency at that time resulted in modifications to how Novavax described the risk of allergic responses and an uncommon heart inflammation side effect known as myocarditis or pericarditis.
From being referred to as “major potential dangers,” the business now refers to them as “significant identified risks” associated with its product.
According to the records, Novavax informed the FDA that company had modified the way the vaccine was being prepared “during the late stage” of its review.
Later testing revealed that these modifications didn’t seem to have an effect on the shots’ quality or purity.
Dr. Peter Marks of the FDA stated that the vaccine “passes the FDA’s high requirements for safety and effectiveness for emergency use authorization” after the doses were approved, based on the agency’s “extensive investigation and review.”
The FDA has rigorously and thoroughly reviewed this vaccine’s scientific and regulatory status, as it does with all vaccines used in the United States, Marks said.