Ayyyeee… What’s Goodie Everyone. So I got some tea and it involves the FDA and the coronavirus vaccine.
A two shot coronavirus vaccine developed by Phizer and a German Firm named BioTech appears to be very close to receiving regulatory clearance, after a 53 page review published Tuesday confirmed that the vaccine appears to meet the standard for emergency use authorization.
The Food and Drug Administration briefing document is the first thing to look at of U.S. regulators assessment of the vaccine as the agency’s career scientists approach one of the most momentous decisions in the FDA’s history. It is also the most detailed independent review yet of data that has so far been known only through company news releases.
The document specifies that the vaccine has cleared the minimum threshold of being at least 50 percent effective and states that the two months of follow up on 38,000 participants in the trial provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an (emergency authorization).
The vaccine was tested in 44,000 people, half of whom received two doses of the real vaccine three weeks apart, and half of whom received shots of saline. People then went about their normal lives and were exposed to the virus in their communities. There were 170 cases of Covid-19, the disease caused by the virus, in the study. Only eight of those cases were in the group that received the vaccine, an overwhelming signal of efficacy and well above the minimum threshold the agency laid out this summer.
The FDA’s career scientists undertook their own thorough analysis of the data over the last two weeks and confirmed Pfizer’s assessment that the vaccine regimen was 95 percent effective at preventing disease in large clinical trial and had tolerable short term side effects that include sore arms, fatigue, headaches, muscle pain and chills that typically resolved within one to two days. The review also found evidence that the vaccine, which is given in two doses, three weeks apart, began to protect people after the first dose.
The Pfizer vaccine is the first of two vaccines to be considered by regulators this month based on a novel technology that uses snippets of the to teach the body’s own cells to build the spiky protein that coronaviruses use to latch onto cells. The immune system, exposed to the spike, can then learn to recognize and block the real virus.
One point of debate among outside advisers to the agency this week could be the length of follow up on a vaccine technology that has never been used in an approved product. The FDA is asking its committee to vote on whether the vaccine has been demonstrated that it may be effective in preventing Covid-19 in people ages 16 and older.
On Thursday, a group of advisers will meet with the FDA will meet for a full day public meeting to discuss the data and make recommendations on whether the vaccine merits authorization for immediate use. A decision, informed but not dictated by that debate, is expected to come within days of the meeting. The first doses are expected to be shipped within hours, with a target of six million doses distributed in the first week.