WASHINGTON (AP) — President Joe Biden’s COVID-19 vaccination campaign hit a snag Tuesday when federal regulators recommended a “pause” in administering Johnson & Johnson shots. But the White House portrayed the action as important validation of his measured approach throughout the rollout.
Biden declared that even with a temporary loss of J&J 's one-shot vaccine, there is a huge supply of Pfizer and Moderna vaccines, enough that "is basically 100% unquestionable, for every single solitary American.”
Perhaps more concerning than any worry about supply, however, is the potential blow to public confidence in all of the vaccines, as polls suggest potentially tens of millions of Americans are hesitant to get the shots that public health experts say are necessary for the nation to emerge from the pandemic.
The pause actually should have the opposite effect, boosting confidence that the government is putting safety first, Biden and top health officials said at a White House briefing. The advisory by the Food and Drug Administration and the Centers for Disease Control and Prevention — citing a need to investigate reports of rare but potentially dangerous blood clots — was “testimony to how seriously we take safety," said Dr. Anthony Fauci, the nation’s top infectious disease expert.
In the opening months of his presidency, Biden has put top priority on a robust response to the virus that has killed 559,000 Americans, with a vaccine campaign in which nearly 50% of adults have received at least one shot.
His actions have received generally strong reviews, and hesitancy toward taking the vaccine has gradually declined as inoculations have increased. With three vaccines in use in the U.S. and plenty of supply in the pipeline, Biden actually has received some criticism for not sharing more vaccines with other nations. The president said Tuesday’s action proved the wisdom of his approach.
“My message to the American people on the vaccine is, I told you all," Biden told reporters after the announcement, adding that he “made sure we have 600 million doses” just from Pfizer and Moderna in the pipeline.
The Johnson & Johnson pause, which regulators say they hope to resolve within days, comes on the heels of production issues at the Baltimore plant that produces the J&J vaccine.
The White House, which got only about 12 hours’ notice that some sort of announcement was coming and did not have any advance warning about the substance of the FDA and CDC’s action, moved swiftly to minimize concerns about its impact. Aides recognized that they had to portray the decision as ensuring the “gold standard” of safety, to avoid feeding into vaccine hesitancy.
“I think it’s a very strong argument for safety actually,” Fauci said.
White House coronavirus coordinator Jeff Zients added that the pause by the agencies “should reassure the American public that they will be very diligent and conservative about how they approach the vaccines.”
They argued the pause proved the prudence of Biden’s cautious approach to promises around vaccine supply and delivery, as well as his administration’s reluctance to make commitments to share excess vaccine with the world because of concerns about potential setbacks such as this.
“They’re clearly trying to reassure people there will be supply, and it will be safe,” said former White House communications director Jennifer Palmieri. “You don’t want this to have happened, but in terms of what are your tools when it does, they used their best ones — the president, the most senior person who has credibility and the top experts — to do it.”
Due to supply issues, the J&J shot reflects just a small share of doses being administered, though it had been one of the most promising vaccines given its ease of administration and distribution. Zients said the U.S. still expects to take delivery of enough doses of the other two approved vaccines for every adult American to get their shots by the end of May. Moderna and Pfizer this week are delivering 28 million doses to the federal government — enough to exceed even the current 3 million shot-per-day pace.
Zients acknowledged that some states may have been caught off guard by Tuesday's announcement but said that reflected the speed with which officials moved to address the safety concerns. He added it was proof of Biden’s commitment to “follow the science” in responding to the pandemic.
“We want the science agencies to lead with science,” Zients said, saying no one at the White House was involved in the decision to call for the pause. “There’s no reason for us to be involved in any of the scientific decisions, we bring nothing to the table.”
The agencies said Tuesday they were investigating unusual clots that occurred in six women, of the more than 7.2 million adults who’ve received the shot. One of the patients died and another remains hospitalized in serious condition.
Officials said the delay had as much to do with educating physicians about the unique way the clots have to be treated as their desire to study the exceedingly rare side effect. The usual treatment, with the blood thinner heparin, could lead to dangerous patient outcomes, they said.
Fauci, speaking at the White House, advised those who had recently gotten J&J shots not to “get an anxiety reaction, because remember it's less than one in a million.” He added, “However, having said that, pay attention” to potential symptoms of the clot including severe headaches, abdominal or leg pain, and shortness of breath.
Dr. Mati Hlatshwayo Davis, an infectious disease physician at the John Cochran VA Medical Center and St. Louis Board of Health, said the J&J pause might affect overall vaccine confidence but the transparency was critical to boosting confidence in minority communities that have some of the lowest uptake of the shots.
“Today was such a sign of strength and of leadership and of improved direction toward rebuilding trust in these communities,” she said of the Biden administration’s forthrightness about the issue. “They came to us as soon as this information became available knowing what was at stake.”
“They’re trusting the American public, and this gives these communities a reason to trust them,” she said.
FRANKFORT — Kentucky temporarily halted using the Johnson & Johnson COVID-19 vaccine Tuesday, but suspending the single-dose shots shouldn't slow the pace of inoculations in coming days due to the availability of other vaccines, Gov. Andy Beshear said.
The Bluegrass State joined in pausing the J&J vaccine rollout as federal health agencies investigate reports of rare but potentially dangerous blood clots. Seeking to reassure Kentuckians who received J&J shots, Beshear said, "You’re going to be OK.”
“We’re going to work through this," he said. "I think it’s going to be deemed safe and effective. But we’re going to pause until everybody knows how to treat ... what appear to be very rare complications.”
Beshear and other governors participated in a call Tuesday with top federal health officials. The governors were told they should expect the J&J vaccine pause to last a few days or possibly a week. The message was that “it is likely not to be longer than that,” Beshear said.
The pause in using J&J vaccine comes a day after the governor set a benchmark of vaccinating 2.5 million Kentuckians to end capacity restrictions at most of the state's businesses and venues.
The suspension “isn’t good news, but it is also not crippling news for our vaccination efforts,” the Democratic governor said at a news conference.
J&J doses represent a fraction of overall vaccines received by Kentucky, and the state has large supplies of Pfizer and Moderna COVID-19 vaccines, Beshear said. That means people with canceled appointments for J&J shots in the next couple of days should be able to sign up in their area to receive their first dose of Pfizer or Moderna vaccine as soon as this week, he said.
“We cannot let this slow us down," the governor said. “And it shouldn’t slow us down.”
With incoming shipments of Pfizer and Moderna doses expected this week, “we ought to be able to make up any loss of appointments from J&J,” he added. Beshear stressed that the Pfizer and Moderna two-shot-regimen vaccines are “entirely safe" and ”incredibly effective.”
The suspension of J&J shots, however, could complicate efforts to overcome vaccine hesitancy among some Kentuckians, Beshear acknowledged.
“Stay calm,” he said. “It looks like the risk here is very, very small versus the really significant risk of being harmed by COVID. They're being careful.”
The U.S recommended the pause in using the J&J vaccine as the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women between the ages of 18 and 48. One person died, and all of the cases remain under investigation. More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
Kentucky has received about 210,000 doses of J&J vaccine, Beshear said. He didn't have a specific number of how many doses had been administered, but he estimated J&J vaccines accounted for less than 5% of overall COVID-19 shots in Kentucky.
Like many states, Kentucky has used J&J shots for more vulnerable and hard-to-reach populations. Inmates at jails and prisons have been among the Kentuckians to receive the single-dose shots.
On Monday, Beshear pledged to lift capacity restrictions at most businesses and venues once 2.5 million Kentuckians have received at least their first COVID-19 shot. Meeting the “vaccination challenge” also would result in removing physical distancing restrictions as well as curfew restrictions on bars and restaurants.
Beshear estimated Monday that about 1.6 million Kentuckians had received at least their first dose of a COVID-19 vaccine. Anyone 16 or older is eligible to be vaccinated in Kentucky.
Meanwhile, the state reported 799 new coronavirus cases and four more virus-related deaths Tuesday. One death was discovered through the state’s audit of deaths from prior months. Kentucky's virus-related death toll rose to at least 6,261.
The state’s rate of positive cases rose to 3.2%. More than 400 virus patients are hospitalized in Kentucky, including 96 in intensive care units.
The Hopkins County Regional Chamber of Commerce and the Hopkins County Agency for Substance Abuse Policy have been awarded the Harm Reduction Grant for $19,816.
Chamber President Libby Spencer said in past years the Chamber has offered an opioid conference to businesses and organizations in the community, educating them on how to deal with the opioid crisis and ways to mitigate substance abuse with their employees.
“Unfortunately, because of COVID-19, we couldn’t have it in 2020 and we would be planning for right about now for 2021, but we can’t gather in large groups,” said Spencer.
Lisa Miller, Hopkins County ASAP coordinator, and the ASAP committee came up with the idea to offer a Training out of Box. All the information they would have talked about at the conference would be put into a box for individual companies to have and teach at their own company, instead of one large conference.
The boxes will contain anything that could raise awareness on how bad an opioid addiction can be, she said. The committee wanted to wait to get the funding before deciding on what to put in the boxes.
“We are reaching out to people in the community to give us some suggestions of what should go in the box,” said Miller. “We are going to start ordering things, start getting things printed and deciding what needs to be in there.”
She said when the Chamber held the conference in 2019, they had over 600 people attend with more on a waiting list.
“We are going to target approximately 500 organizations and businesses — Chamber members and non-Chamber members,” said Miller. “We will also be looking at not-for-profit organizations that would be interested in the training.”
Though she did not have specific numbers, Miller said the committee, which consists of a diverse group from the community, have been seeing and hearing of more overdoses and substance abuse problems.
“There is some speculation that it has gotten worse because of the pandemic,” she said.
The training is the first step to help the community’s opiate/heroin prevention and treatment needs, said Miller.
“Employers need employees without opioid use disorder to hire and need help to understand how to deal with current employees struggling with the unique challenges of having an opioid disorder,” she said.
Construction for the Grapevine Bike Trails is nearing the halfway mark and is still on target for the projected completion, according to Madisonville Mayor Kevin Cotton.
Trail access is also limited as construction continues, but Cotton said the contractor, Rogue Trails, LLC, anticipates a completion by the mid-May.
“There is equipment out there working, and there will be pieces of the trail that will be closed throughout the process,” said Madisonville Public Relations Manager Sara Lutz, who added that after a meeting on Friday she will have a better idea of when the grand opening event will be and other milestones in the project.
“It is looking great, and things are moving quickly,” she said.
Cotton said while the trails may be closed as work continues, he does not anticipate them being closed long.
“Anytime you try to go through a new project, there’s going to be some inconvenience for those that might have been using them before,” he said. “Our goal is to try and continue to operate as much as possible, and we want to be sure we are being safe. Once this opens up, it is going to be a phenomenal asset to the community.”
Cotton said over the next three weeks, the trails will have made a “major transformation.”
He also said weather conditions have allowed for Rogue Trails to make progress in their construction.
“We are anticipating mid-May of being able to have it done, which was the target date,” Cotton said.
Rogue Trails has run into problems also with people using the closed trails while the ground was still wet from recent rain.
The Southwest Kentucky Mountain Biking Association reiterated the importance of staying off the closed trails while work continues.
“Unfortunately, riders have been riding the trail while closed and in wet, muddy conditions,” the group posted on Facebook. “A lot of time, money and hard work has been invested. The more time the Rogue crew spends repairing unnecessary trail damage, the less time they have to focus on building additional new trail.”
The bid for the project was awarded to Rogue out of Rogers, Arkansas, for $330,120.
The project is being done in three phases.
The first phase, called the red loop, will replace the trail with four miles of multi-use trail on the west side of the boat ramp access road.
The second phase, called the blue loop, will replace three miles of trail on the east of the boat ramp access road and will be a single track trail system for shared use for mountain bike racing and a training course.
The third phase will create two half-mile mountain bike flow trails that will go parallel on each side of the boat ramp access road.
The first phase is expected to cost an estimated $136,244; the second phase is expected to cost an estimated $118,800 and the third phase is expected to cost an estimated $72,874.
In October 2020, the Hopkins County Tourist and Convention Commission approved up to $131,157.60 to help pay for the project with the City of Madisonville agreeing to pay 60% of the project, with the total cost of the project estimated to be $327,898.