The Register Citizen (Torrington, CT)
Early vaccine release concerns experts
Connecticut health experts are skeptical, but hopeful about recent reports that limited doses of a COVID-19 vaccine could be available as soon as late October.
The New York Times reported this week that it obtained documents sent by the Centers for Disease Control and Prevention to health officials in all 50 states, informing them that a COVID-19 vaccine could be available by fall.
One of the documents listed planning scenarios, all of which pointed to at least some vaccine — between 1 million and 2 million doses — being available by the end of October, with distribution increasing over time.
Another document mentions “limited” doses could be available by November, and that availability will “increase substantially” in 2021.
The CDC documents said any COVID-19 vaccine will either “be approved as licensed vaccine or authorized for use under an Emergency Use Authorization issued by the U.S. Food and Drug Administration.”
The information came as a shock to local experts, as the earlier target date mentioned for vaccine availability was
January 2021.
Even reaching that date has required skipping steps in the vaccine approval process, which typically takes years. In July, the National Institutes of Health reported that a vaccine developed by NIH and Moderna was in phase 3 of clinical trials.
Other vaccines are in development as well, including one produced by Pfizer and BioNTech.
The idea that the vaccine could be available even sooner than originally thought is a bit worrisome, said Alvin Tran, assistant professor of public health in the University of New Haven’s School of Health Sciences
“I have many concerns with the expedited process of approving a coronavirus vaccine,” he said. “The original goal of having a vaccine in early 2021 was already a bit ambitious.
“Moving that deadline up to October 2020 while the clinical trials are still underway does give me concern. What we want is a vaccine that not only works but is safe. We need definitive results from the existing clinical trials to make that determination.”
The CDC document with the planning scenarios does say the plans are still hypothetical.
“The COVID-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available,” the document states.
The papers also outline how early doses of vaccine could be distributed, with health care workers and staff and residents of long-term care facilities among the prioritized groups.
Last month, representatives of the Infectious Diseases Society of America and the HIV Medicine Association sent a letter to FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, saying “making a vaccine available before sufficient safety and efficacy data are available could significantly undermine COVID-19 vaccination efforts and seriously erode confidence in all vaccines.”
Those concerns are shared by Summer Johnson McGee, dean of the School of Health Sciences at the University of New Haven.
“Promises of a late fall 2020 vaccine are really pushing the envelope,” she said. “Early release of a vaccine to health care workers and at-risk groups seems reasonable but realistically the vaccine is unlikely to be widely available until summer 2021.
“The risks of bringing a vaccine to market too soon are considerable so there is still a long road ahead of surveillance and monitoring to ensure any vaccine is safe and effective in the long term.”
Though other experts shared Tran and McGee’s reservations, some pointed out the expedited vaccine process is just one more sign that we’re living in unprecedented times.
“Am I skeptical? A little, but my skepticism has a lot to do with how vaccine approval is supposed to go,” said Keith Grant, the senior system director of infection prevention at Hartford Healthcare.
But, Grant pointed out, COVID-19 has sparked changes in many areas, including testing and treatment. When it comes to this virus, he said, the typical rules no longer seem to apply.
“This is completely beyond what we’re used to,” Grant said.
Dr. Zane Saul, chief of infectious disease at Bridgeport Hospital, echoed that skepticism mixed with optimism. He said he worries there might be political reasons for pushing the vaccine to market, as the CDC dates would have a vaccine available in advance of the 2020 presidential election.
However, Saul said, he trusts the judgment of the CDC in this matter.
“If the CDC endorses the vaccine and they say it’s OK, then we stand by the CDC,” he said.
That doesn’t mean he wouldn’t like a chance to see the vaccine research for himself. “Hopefully, they will release more data and we can have a chance to review it,” Saul said.