There is light at the end of the COVID-19 tunnel as the first mass distribution of the Pfizer vaccine began in earnest Monday. However, there isn’t enough of the vaccine to vaccinate the frontline healthcare providers that the initial shipments are reserved for. The shipments of more of the vaccines are expected through December.
Hanging in the balance is the Moderna vaccine that is being reviewed by the Food and Drug Administration (FDA) advisory committee this week. The FDA advisory committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the FDA has regulatory responsibility.
Like last week’s FDA advisory committee review of the Pfizer vaccine, a decision on Moderna will be made this Thursday (Dec. 17) or at the latest Friday, (Dec. 18). And like last week the early review is very positive. On Tuesday, the FDA said in documents posted online that its initial review confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing the vaccine to the verge of emergency authorization use.
In tests the Moderna vaccine has proven to be 95 percent effective in its 30,000-person study. In short that means that for every 100 people it tested in its studies 95 people had positive reactions. The Moderna vaccine mechanisms is near-mirror similar to the Pfizer vaccine.
The FDA advisory committee announced Tuesday afternoon that the Moderna vaccine is 100 percent effective on people age 65 or older.
Both vaccines are made with the same technology, using a piece of genetic code for the “spike” protein that studs the virus. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.
Moderna plans to have 20 million doses ready for the U.S. by the end of December. Recipients will need two doses, so that’s enough for 10 million people.
Pfizer expects to have 50 million doses available globally in December. Twenty-five million doses are earmarked for the U.S. The vaccination also requires two doses, so that will be enough to vaccinate 12.5 million people.
Moderna and Pfizer will go full-throttle production in 2021.
Moderna aims to produce at least 500 million doses next year, with the possibility of scaling up to 1 billion doses depending on the availability of raw materials. Pfizer aims to make 1.3 billion doses in next year.
The CDC estimates that the at-risk population should be vaccinated by February or March, and the general public by June or July.