HANCOCK COUNTY — Medicap Pharmacy in Greenfield was all set to start administering its first COVID-19 vaccinations Tuesday using the Johnson & Johnson vaccine.
“We were ready to go today,” said owner and pharmacist Dave Bush on Tuesday.
Then federal and state agencies announced recommendations to pause on using that particular shot pending an investigation into a rare but potentially dangerous side effect.
About 1,500 Hancock County residents have received the single-dose J&J vaccine since its use was approved in late February. Those behind some of the vaccination efforts in the county say they plan to heed the hold and encourage J&J recipients to keep a lookout for certain side effects. They also maintain that although not free of risks, the vaccine is safe. However, they can’t help but fear the development will inject skepticism into the global inoculation effort.
The recommended J&J pause came as the Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual blood clots that occurred six to 13 days after vaccination. The pause is expected to last a matter of days.
The Indiana State Department of Health on Tuesday seconded the request for the pause.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets, the fragments in blood that normally form clots. All six cases were in 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 given in the U.S., the vast majority with no or mild side effects.
Federally run mass vaccination sites will pause the use of the J&J shot, and states and other providers are expected to follow. The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the U.S. and are not affected by the pause.
An upcoming mass vaccination clinic at the Indianapolis Motor Speedway had planned on using the Johnson & Johnson vaccine, but will switch to the two-dose Moderna vaccine.
The CDC and FDA recommend that people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks.
Bush said such a small amount of adverse cases spurring the recommendation left him surprised.
“It’s significant, so I think it’s important that the CDC do due diligence here, and the FDA,” he added.
He expects the matter will scare some from getting vaccinated, which he called unfortunate.
“If we can’t get everybody vaccinated, it’s harder to stop the virus,” he said.
Bush is looking forward to the investigation getting resolved soon.
“We hope we can get going again and we will as soon as they give us a green light to do it,” he said.
Hancock Regional Hospital’s COVID-19 vaccination clinic has not administered any doses of the Johnson & Johnson vaccine, but clinics through the Hancock Physician Network have administered about 150.
Dr. Julia Compton, CEO of the physician network, said no serious side effects were reported from those shots, but that the network has started reaching out to the recipients to let them know what they should watch for.
“Upon learning the news from the federal government, we held any vaccine administration of the J&J vaccine going forward until we understand the data and the recommendations,” Compton also said.
She said the recent developments don’t mean the J&J vaccine is unsafe.
“I think there’s a lot of suspicion on if it’s related to the vaccine at all,” she said of the clotting, adding it could have something to do with the vaccine manufacturing process or an underlying condition the impacted patients shared. “That’s the data that needs to be looked at.”
There’s always a risk with any vaccine, she said. And while rare, they can still be significant.
“When it happens, it’s not incredibly rare to you if you are the less-than-1% and it happens to you,” she said.
They physician network will likely start transferring its J&J vaccine appointments into the hospital’s COVID-19 vaccination clinic, where other vaccines are used, Compton said.
She said she was disheartened by the news, and, like Bush, fears it may add to suspicion against COVID-19 vaccinations.
“I think it will contribute to the mistrust that some people might still have, or reservations some folks might still have about getting any vaccine,” she said.
Tim Livesay, director of pharmacy for Hancock Regional Hospital, said he, too, doesn’t think the J&J vaccine is unsafe and that those who have already gotten it shouldn’t worry if they haven’t experienced any side effects.
“My understanding is if you’ve not had the reaction to it or developed any issues, you’re probably going to be fine,” he said.
Side effects from the other COVID-19 vaccines administered at the hospital’s clinic continue to be rare and mild, Livesay also said.
Any slowdown in the dissemination of the shots could have broad implications for the global vaccination effort. The J&J vaccine held particular promise for less affluent countries because its single-dose regimen and relatively simple storage requirements make it easier to use in the developing world.
The reports of the blood clots appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.
A CDC committee will meet today (Wednesday, April 14) to discuss the cases, and the FDA has also launched an investigation into the cause of the clots and low platelet counts.
Authorities have not seen similar clots after use of the Pfizer or Moderna vaccines, the CDC said.
FDA officials emphasized that Tuesday’s action was not a mandate. Doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases.
J&J said in a statement that it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it would delay the roll-out of its vaccine in Europe as a precaution.
Jeff Zients, the White House COVID-19 response coordinator, said 28 million doses of the Pfizer and Moderna vaccines will be available for states this week, more than enough to keep up the nation’s pace of 3 million shots a day despite the J&J pause.
The Associated Press contributed to this story.
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COVID-19 data through early Tuesday, April 14
Hancock County
- 165 new tests administered (April 6-12)
- 17 new cases (April 12)
- 6.6% seven-day (March 31-April 6) positivity rate all tests, 9.6% cumulative rate
- 0 new deaths
- 96,452 total tests administered
- 41,080 total individuals tested
- 7,896 total cases
- 15.1% seven-day (March 31-April 6) positivity rate unique individuals, 19.2% cumulative rate
- 139 total deaths
- 21,386 fully vaccinated
- 51,084 total vaccination doses administered
- 29,698 first doses in two-dose series (Moderna and Pfizer)
- 19,880 second doses in two-dose series
- 1,506 single-dose series (Johnson & Johnson)
Indiana
- 22,208 new tests administered (Aug. 5, 2020-April 12, 2021), 3,895 new individuals tested
- 970 new cases (April 12)
- 4.9% seven-day (March 31-April 6) positivity rate all tests, 9.1% cumulative rate
- 16 new deaths (Nov. 25, 2020-April 12, 2021)
- 9,264,312 total tests
- 3,307,770 total individuals tested
- 700,775 total cases
- 12.9% seven-day (March 31-April 6) positivity rate unique individuals, 21.2% cumulative rate
- 12,762 total deaths
- 58% ICU beds in use – non-COVID
- 8.1% ICU beds in use – COVID
- 33.8% ICU beds available
- 17.3% ventilators in use – non-COVID
- 2.8% ventilators in use – COVID
- 79.9% ventilators available
- Hospital census: 881 total COVID-19 patients (628 confirmed, 253 under investigation)
- 1,433,533 fully vaccinated
- 3,451,895 total vaccination doses administered
- 2,018,362 first doses in two-dose series (Moderna and Pfizer)
- 1,304,750 second doses in two-dose series
- 128,783 single-dose series (Johnson & Johnson)
Source: Indiana State Department of Health
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