President-elect Joe Biden released a crucial element of his new coronavirus vaccine plan Friday, as his office announced he doesn’t intend to hold back doses of the authorized vaccines to ensure that people already vaccinated have a waiting dose for a second shot.
This is a reversal of what the Trump administration has been doing.
“The president-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible,” said Biden spokesman T.J. Ducklo. “He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now.”
Biden’s strategy apparently assumes drug manufacturers will be able to produce enough vaccines to enable people to get their second dose in a timely manner, and he pledges to invoke the Defense Production Act to make sure that enough vaccines and supplies are made available.
On the surface this plan would appear to contradict Food and Drug Administration policy. This policy authorizing the emergency use of vaccines produced by drug companies Pfizer and Moderna was based on clinical trials that showed the vaccines were safe and about 95% effective for people receiving two shots at set intervals
.It is impossible to ascertain with certainty exactly what one shot alone would mean in terms of persistent immunity, since this has only been studied in conjunction with a second shot.
FDA Commissioner Dr. Stephen Hahn spoke with me about this on SiriusXM’s “Doctor Radio” this week and stated that he believes the second shot must be given at the predetermined studied interval under the terms of the emergency use authorization for the two vaccines.
This is not necessarily the same thing as saying the second vaccine doses should remain in federal deep freeze. In fact, I have no problem whatsoever with the Biden plan providing that the recipients adhere to the terms of the FDA’s conditional approval. In other words, increase the vaccine supply, but ensure proper administration based on current science and federal law.
The part that needs to change is the strict adherence to the pecking order. This is meant as guidance only, but is being too strictly enforced.
This is the main reason that with over 22 million vaccine doses distributed as of Friday night, only 7 million shots have been administered.
Stories abound of vaccines being discarded when they haven’t been used in time after being unfrozen.
It is tragic that regulations are getting in the way of immunizations, especially when there are plenty of custodial workers, food preparers, elderly patients and other high-risk individuals who would line up to take vaccines that suddenly became available.
Every hospital, clinic, pharmacy and vaccine center that is administering the COVID-19 vaccines needs a “B” list of people who are eager to get a shot. At the same time, we need more vaccine centers, staffed around the clock, and more flexibility — not more red tape.
New York Gov. Andrew Cuomo has announced an informal rule for his state that he has named after his mother, called Matilda’s Rule.
As of Monday, everyone listed as “1-B” for vaccine priority — people over age 75; those at high risk of COVID-19 complications; and essential workers including police, firefighters, postal workers and teachers — will be eligible a the vaccination.
But at the same time, the governor said Friday that it could take up to 14 weeks (mid-April) before this group is fully vaccinated. His mother, he indicated, would be no exception.
I received dozens of calls and emails from my elderly patients Friday asking for a vaccine, but I have had to tell each and every one of them that a reservation is a promise — not an appointment.
Even though there are plans to build a vaccine center in the Javits Center in New York City and to expand capabilities all around the state, it will be a long time before the supply is there to meet the full demand.
In the meantime, Cuomo’s excess regulations and prioritizations and threatened fines clearly slow the wheels of progress towards widespread vaccinations that will lead to herd immunity. Cuomo announced Monday that hospitals in his state could be fined $100,000 if they did not administer all their vaccine doses this week, and could be denied further doses.
As I wrote in my book, “COVID: The Politics of Fear and the Power of Science,” the last thing we need is for political posturing and blame to impede the vaccine rollout.
To realize how fumbled the current vaccine rollout is, we can look to back to 1947, when a single case of smallpox in New York City led to a mass vaccination program of 6 million people in less than a month, using glass syringes as opposed to modern techniques.
It is disturbing to consider that even as vaccine science itself advances so dramatically, the deployment of our new best weapon against the burgeoning pandemic might be better accomplished using a simpler more old-fashioned historical model.