Great News: Approval Pending
Great news: the COVID-19 vaccines are coming.
The Pfizer coronavirus vaccine is both safe and effective, according to the U.S. Food and Drug Administration—and has been authorized for use by health officials in Canada, the UK and Bahrain. In a report released Tuesday morning, the FDA indicated that it could greenlight the country’s first Covid-19 inoculation as soon as this Thursday.
The meeting begins at 9 a.m. ET on Thursday and will be livestreamed on YouTube. The panelists will appear remotely via videoconference. The committee will meet in open session and hear presentations from the FDA; an update on the Covid outbreak; details about the safety and effectiveness of the vaccine and distribution plans; Pfizer’s findings; and a question-and-answer period, before voting.
Pfizer’s is the most-advanced vaccine candidate. It released data last month, saying its vaccine was 95% effective and safe, and the latest data analyses from FDA say that they have found no serious safety concerns related to the vaccine, that it works well regardless of race, weight, or age, and that it starts providing strong protection against COVID-19 within about 10 days of the first dose. That’s even sooner than Pfizer had previously announced!
States are on high alert waiting for the first shipments of the vaccine to go out. The White House has promised to get the vaccine to all 50 states, the District of Columbia and five U.S. territories within 24 hours of the decision. How much vaccine each state will get at the beginning is theoretically based on simple math, and according to the Department of Health and Human Services, the first 2.9 million doses will be divided by state population.
A CDC advisory panel voted on Tuesday recommended giving first priority to health care personnel and residents of long-term health care facilities. They will likely be followed by the elderly, people with high-risk comorbidities and essential workers. Each state has submitted to the CDC a vaccine distribution plan (click here to find your state), and state and local officials will be charged with implementing them. The CDC anticipates there will be enough doses of the Pfizer vaccine for 20 million people by the end of December.
Up next...on December 17, officials will meet to discuss recommending Moderna's COVID-19 vaccine for emergency authorization. If authorized, this will put out an additional 20 million doses of ready-to-use coronavirus vaccine by the end of December. Moderna estimates that it will manufacture 1 billion doses of its vaccine globally by the end of 2021.
With both vaccines showing close to 95% effectiveness, it looks like this is the next critical step to addressing the current pandemic—and perhaps imperative to getting us safely back to our normal, everyday lives.
Shameless plug for my hardworking husband, featured here with Sebastian Gorka on America First, discussing Operation Warp Speed and the coronavirus vaccine.