
The Truth about the FDA:



Following trial results released yesterday showing Moderna’s vaccine candidate might not be safe for human consumption – apparently, the candidate caused “adverse” reactions in roughly 50% of patients who participated in a recent study – the dozens of companies, universities and governments working on COVID-19 vaccine candidates just received another piece of disheartening news: A growing body of evidence gleaned from research into the virus suggests that antibodies may not offer protection for more than 2-3 months, for many people.
It might be the next best thing to a coronavirus vaccine.
Scientists have devised a way to use the antibody-rich blood plasma of COVID-19 survivors for an upper-arm injection that they say could inoculate people against the virus for months.
Using technology that’s been proven effective in preventing other diseases such as hepatitis A, the injections would be administered to high-risk healthcare workers, nursing home patients, or even at public drive-through sites — potentially protecting millions of lives, the doctors and other experts say.
The two scientists who spearheaded the proposal — an 83-year-old shingles researcher and his counterpart, an HIV gene therapy expert — have garnered widespread support from leading blood and immunology specialists, including those at the center of the nation’s COVID-19 plasma research.
But the idea exists only on paper. Federal officials have twice rejected requests to discuss the proposal, and pharmaceutical companies — even acknowledging the likely efficacy of the plan — have declined to design or manufacture the shots, according to a Times investigation. The lack of interest in launching development of immunity shots comes amid heightened scrutiny of the federal government’s sluggish pandemic response.
Politicians, government officials and pharma executives alike have been predicting a COVID-19 vaccine debut by year’s end, but Merck CEO Kenneth Frazier doubts that’s possible—and Merck has enough vaccine experience to know the obstacles ahead.
Instead, those who are promising vaccines later this year could be hurting the overall fight against the pandemic, Frazier figures.
In an interview with Tsedal Neeley, the Naylor Fitzhugh Professor of Business Administration at Harvard Business School, Frazier said officials are doing a “grave disservice” to the public by talking up the potential for vaccines later this year. There are massive scientific and logistical obstacles to achieving such a feat, he said.
“What worries me the most is that the public is so hungry, is so desperate to go back to normalcy, that they are pushing us to move things faster and faster,” Frazier said. “Ultimately, if you are going to use a vaccine in billions of people, you’d better know what that vaccine does.”

You must be logged in to post a comment.