J&J vaccine on hold pending FDA and CDC review

By: 
Travis Fischer

The planned surge of COVID-19 vaccine distribution was put on hold last week when a pause was announced on the Johnson & Johnson vaccine.

Early last week, just as public health clinics across the state were preparing to distribute their supply of the anticipated vaccine, the CDC and FDA recommended a pause in the deployment of the vaccine due to reports of a rare blood clotting condition.

“This was a surprising setback at a time when our vaccine efforts are showing much progress,” said Governor Kim Reynolds on Wednesday, April 14 during her regular press conference.

Six cases of the blood clotting condition in women between the age of 18 and 48 have been reported nationwide. Similar cases have turned up in Europe in women of the same age range that have been given a vaccine that works similarly to the Johnson & Johnson vaccine.

Dr. Pat Winokur, Executive Dean of the University of Iowa’s Carver College of Medicine was present at the conference to explain both the blood clotting condition and what it means for the vaccine.

“This is a disease that many of us have not seen, and they are taking the appropriate caution to review these cases,” said Winokur. “I think the fact that we did pause is important. It’s what we want the system to do.”

That said, Winokur assured that this pause is not an indication that the Johnson & Johnson vaccine was rolled out too quickly or is inherently unsafe, noting that each of the vaccines was tested on ten times the number of people that are typically used in trials. Winokur also noted that rare side effects are an inevitability in any drug when distributed among millions of people.

“Every drug that we create has rare side effects,” said Winokur. “We don’t see those side effects until we start distributing the vaccine or drug into the general public and millions of people are dosed. That’s what we’re seeing here. A one in a million type of event.”

Regarding the risk/benefit ratio, Winokur explained that the risk of a severe complication when getting the vaccine is still many orders of magnitude smaller than the risk of getting COVID-19. To date, while less than one in a million people that have received the Johnson & Johnson vaccine have suffered from the blood clot complication, 18,000 out of every million Americans that have gotten COVID-19 have died.

The pause on the Johnson & Johnson vaccine is expected to last until the CDC and FDA can study the blood clotting condition and issue guidance to doctors on what to look for, how to treat it, and how to determine if an individual may be particularly susceptible to it.

In the meantime, the state will continue on with the distribution of Moderna and Pfizer vaccines until the Johnson & Johnson vaccine is again cleared for use.

In spite of the pause, the State of Iowa crossed the two million dose milestone last week, with 195,453 doses of vaccine administered bringing the total to 2,060,963. This includes 950,104 doses of Moderna; 1,023,759 doses of Pfizer; and 87,100 doses of Johnson & Johnson’s Janssen vaccine.

Another 108,905 Iowans completed their vaccination series in the last week. With 795,683 completing their two dose vaccination and another 87,100 that have received the J&J vaccine, that brings the total number of vaccinated Iowans to 882,783.

As of Sunday, April 18, there have been 360,054 individuals positive with COVID-19 in the state, increasing the 357,018 total from the week prior by 3,036, a small reduction of new cases from the previous week.

The state has performed a total of 4,665,904 tests on 1,682,317 individuals since the pandemic began, including 3,029,649 PCR tests and 1,636,255 antigen tests. In the last week, the state has processed 41,942 PCR tests and 39,154 antigen tests.

In the last week, 9% of new cases have been among the elderly (age 80+), 14% among older adults (60-79); 28% among middle aged adults (40-59); 44% among young adults (18-39); and 4% among children.

120,919 Iowans have undergone serology testing for coronavirus antibodies, which would indicate that they have had the virus. Of that number, 22,794, about 19% have tested positive for antibodies.

Of the 1,004 individuals tested in the last week, 203 of them (20%) have tested positive.

Hospitalizations are finally starting to decline again, with 205 hospitalized as of Sunday, a decrease of 15 from the week prior. Severe cases have dropped as well, with 51 people currently in an ICU.

Reported deaths are also on the decline, with the state reporting 24 deaths last week, bringing the state’s total to 5,881.

In total, approximately 3,446 elderly (58.61%); 2,024 older adults (34.43%), 358 middle aged adults (6.09%), 49 young adults (.83%), and at least one child (.03%) have died from the virus since the pandemic began.

The state has also reported six additional deaths from long term care facilities, bringing the total to 2,301.

One of Iowa’s recent outbreaks in their long term care facilities has been mitigated, bringing the total number of outbreaks back down to two. This brings the number of active cases among residents and staff to 23, down five from the previous week.

 

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