To Get or Not Get a 3rd Vaccine Dose....
Decisions about a 3rd mRNA vaccine became even more complicated this week. What is the US trying to achieve with vaccines? What clinical trial data is available that supports the need of a 3rd dose? Who should get 3rd doses and when? What is our obligation to other countries?
1. Is there enough data to demonstrate that we need it? Not yet. The recent information from Israel is not yet published or presented fully. The breakthrough cases and results from other studies from August will be analyzed for more information with both mRNA vaccines (Israel uses Pfizer). There are different opinions about the necessity from very good scientists. And almost always the US "waits for the science" before making a recommendation.
2. It is estimated that there are a million people who already made a decision and got their 3rd dose, and no data has been collected re: efficacy and safety in a standardized way.
3. Pfizer already submitted their proposal to give a third dose. Today it was reported that Moderna applied to give a 3rd dose, but the amount in the dose is slightly different than their first and second shots. That may delay their data review and slow their FDA and CDC approval.
4. Third doses were approved by both the CDC and FDA for patients with immune deficiency and they are currently being administered. The 3rd dose of the vaccine for the general public needs to be approved by them too. The FDA VRBPAC meeting is scheduled for September 17th. The CDC ACIP meeting is not yet on their schedule. See Below
Other information:
Israel: "Israeli officials say their data shows that the potency of Pfizer's vaccine wanes over time against severe disease and hospitalization, but that a third shot bolsters protection significantly. The FDA wants to see the raw data, to make sure it backs up summaries that the Israeli government has provided." NYT Sept 3,2021
Sharing our vaccines with the world: 130 million doses have already been shipped to 90 countries. And 200 million more doses will be shipped before the end of 2021 and another 300 million doses before July 2022. This is data presented by Dr. Fauci at this week's White House Briefing. There are also plans for the US to develop and fund more vaccine manufacturing.