Gen. Gustave F. Perna, who heads Operation Warp Speed, the Trump administration’s multiagency effort to get coronavirus vaccines out to Americans, apologized repeatedly on Saturday morning for confusion over vaccine deliveries to states.
He attributed some of the problems to the federal government’s miscalculation of how many doses of Pfizer-BioNTech’s vaccine could be shipped. The discrepancies disrupted vaccination plans and stirred consternation in at least 14 states.
General Perna is in charge of the logistics for distributing the coronavirus vaccines to the states, and he took full and sole responsibility for the delays and confusion around the vaccine rollout, and for the discrepancies between the number of doses states were expecting and what they are receiving.
“It was my fault,” he said. “It was a planning error, and I am responsible.”
“I want to take personal responsibility for the miscommunication,” General Perna said at a news conference. He said the number of vaccines available to allocate ended up being lower than initial forecasts.
“I had to lower the allocations to meet the releasable doses that were presented to me,” General Perna said. “So to the governors,” he said, “please accept my personal apology if this was disruptive in your decision-making.”
He added that he did not understand with “exactness” the requirements for the release of each batch of doses. He referred several times to the Food and Drug Administration’s involvement, but was unclear about how that would have delayed shipments.
The F.D.A. merely requires a certificate that includes the results of quality control tests for each lot of vaccine at least 48 hours before distribution and does not require the certificates be reviewed before shipments occur. That enables the F.D.A. to keep track of the batches being shipped. The requirement is included in the emergency authorization paperwork the F.D.A. sent to Pfizer.
Covid-19 Vaccines ›
Answers to Your Vaccine Questions
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
-
- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
Officials in Oregon, Iowa, Washington, Massachusetts, Wisconsin, Vermont, Minnesota, Nevada, Connecticut, California, Michigan, Idaho, Virginia and New Jersey said that they were caught off guard on Wednesday when they learned that next week’s shipment of the vaccine would contain fewer doses than the first week’s.
Governors and state health departments have spoken with alarm this week of how few vaccines they have received compared with what had been promised.
“This is disruptive and frustrating,” Gov. Jay Inslee of Washington wrote on Twitter on Thursday. “We need accurate, predictable numbers to plan and ensure on-the-ground success.”
Dr. Mark Levine, commissioner of the Vermont Department of Health, said in a Friday briefing that “all my colleagues in the region are reporting a 25 to 35 percent decrease in their allocation for next week.”
“As we were walking in, I learned as many as 975 doses out of an expected 5,850 doses would not be coming in when we expected,” he said. “What everyone around the country is upset about, in addition to just the number, is there’s been no communication, so there’s no understanding of what this really means.”
On Saturday, General Perna noted that boxes of the Moderna vaccine, which was approved for emergency use by the Food and Drug Administration on Friday, were being packed and loaded, and that truckloads would begin rolling out on Sunday.
He said that the government remained on track to allocate about 20 million vaccine doses across the country by the end of December, and that the distribution of those doses would be “pushing into the first week of January.”
“There is no problem with the process,” he said. “There is no problem with the Pfizer vaccine. There is no problem with the Moderna vaccine.”
“It was a planning error, and I am responsible,” he added.
He also expressed confidence that “we will have the agility to correct ourselves and get things right, so that the next time it will go flawlessly.”
This article is auto-generated by Algorithm Source: www.nytimes.com
