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CDC, FDA lift stay on Johnson & Johnson vaccine

Green light on the one-shot vaccine offers health agencies more choices in their arsenal against COVID-19

Medical assistant Adriana Castaneda draws the Moderna COVID-19 vaccine into a syringe at Ravenswood Family Health Center in East Palo Alto on Jan. 30, 2021. Photo by Magali Gauthier.

Federal authorities have lifted a "pause" on the use of the Johnson & Johnson vaccine, potentially opening thousands of appointments for COVID-19 shots in the coming weeks.

The Centers for Disease Control and Prevention and Food and Drug Administration announced the removal of the pause on April 23, noting that the concerning adverse effects have affected only 15 people out of 6.8 million doses.

The federal agencies recommended the pause on April 13 after six women developed rare blood clots, or thrombosis involving the cerebral venous sinuses — large blood vessels — in the brain. All of the cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Symptoms began between six and 15 days after vaccination, the CDC noted.

The stay was lifted after a thorough scientific review determined that the benefits of the Johnson & Johnson, also known as the Janssen vaccine, outweigh the risks.

The federal agencies assessed reports submitted to the Vaccine Adverse Event Reporting System and reviewed information about some similar adverse effects in another vaccine that uses a modified inactive virus from the adenovirus family. The Astrazeneca vaccine, which is similar but not identical, was also modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19 infections.

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The agencies plan to continue monitoring the J&J vaccine for adverse effects, they said.

"We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality," CDC and FDA officials said in a press release on Friday. The vaccine doses will come with a new warning label and a fact sheet that warns of the rare blood clots.

Santa Clara County said in a statement that it "will follow guidance from the CDC and California Department of Public Health regarding the timelines and guidance for restarting use of the Johnson & Johnson vaccine."

In California, as an additional safeguard, the Western States Scientific Safety Review also will examine the vaccine and make recommendations to the state Department of Public Health.

Santa Clara County has benefited from a boon of 300,000 doses of the two-shot Pfizer-BioNTech and Moderna vaccines, which it received through a federal Health Resources and Services Administration program.

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Nine health officers from the greater Bay Area on Sunday released a statement supporting recent federal guidance to lift the pause on the Johnson & Johnson COVID-19 vaccine for adults.

The health officers, from the counties of Alameda, Contra Costa, Marin, Napa, San Francisco, Santa Clara, Santa Cruz, and Solano, and the city of Berkeley, said they agree with findings that the vaccine is safe and the risk of developing the rare clotting disorder is extremely low.

Sunday's statement from the health officers recommends Bay Area health providers resume administering the Johnson & Johnson vaccine in an effort to prevent community spread and severe illness and death from COVID-19.

San Mateo County officials said on Friday they will follow all safety guidelines from the state and federal authorities. The county has 1,220 doses of Janssen/Johnson & Johnson on hand and will begin to integrate the vaccine back into its plans, a spokesman said on behalf of the county.

Anyone who has received the Johnson & Johnson vaccine should contact their primary health care provider if they have concerns or if they develop severe symptoms of headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination, the health officers said.

The single-dose Johnson & Johnson vaccine was considered an important component in getting shots in the arms of residents, particularly those who might balk at the two-shot regimen, which is given about 21 to 28 days apart. The vaccine also was considered an important breakthrough for people who are homeless or are homebound and can't easily access the two-shot regimen, county officials have said. The Janssen vaccine is also stored at higher freezer temperatures than the Pfizer and Moderna vaccines, facilitating its distribution without need for more specialized freezers.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

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Bay City News Service contributed to this report.

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CDC, FDA lift stay on Johnson & Johnson vaccine

Green light on the one-shot vaccine offers health agencies more choices in their arsenal against COVID-19

by / Palo Alto Weekly

Uploaded: Fri, Apr 23, 2021, 7:58 pm
Updated: Mon, Apr 26, 2021, 8:56 am

Federal authorities have lifted a "pause" on the use of the Johnson & Johnson vaccine, potentially opening thousands of appointments for COVID-19 shots in the coming weeks.

The Centers for Disease Control and Prevention and Food and Drug Administration announced the removal of the pause on April 23, noting that the concerning adverse effects have affected only 15 people out of 6.8 million doses.

The federal agencies recommended the pause on April 13 after six women developed rare blood clots, or thrombosis involving the cerebral venous sinuses — large blood vessels — in the brain. All of the cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Symptoms began between six and 15 days after vaccination, the CDC noted.

The stay was lifted after a thorough scientific review determined that the benefits of the Johnson & Johnson, also known as the Janssen vaccine, outweigh the risks.

The federal agencies assessed reports submitted to the Vaccine Adverse Event Reporting System and reviewed information about some similar adverse effects in another vaccine that uses a modified inactive virus from the adenovirus family. The Astrazeneca vaccine, which is similar but not identical, was also modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19 infections.

The agencies plan to continue monitoring the J&J vaccine for adverse effects, they said.

"We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality," CDC and FDA officials said in a press release on Friday. The vaccine doses will come with a new warning label and a fact sheet that warns of the rare blood clots.

Santa Clara County said in a statement that it "will follow guidance from the CDC and California Department of Public Health regarding the timelines and guidance for restarting use of the Johnson & Johnson vaccine."

In California, as an additional safeguard, the Western States Scientific Safety Review also will examine the vaccine and make recommendations to the state Department of Public Health.

Santa Clara County has benefited from a boon of 300,000 doses of the two-shot Pfizer-BioNTech and Moderna vaccines, which it received through a federal Health Resources and Services Administration program.

Nine health officers from the greater Bay Area on Sunday released a statement supporting recent federal guidance to lift the pause on the Johnson & Johnson COVID-19 vaccine for adults.

The health officers, from the counties of Alameda, Contra Costa, Marin, Napa, San Francisco, Santa Clara, Santa Cruz, and Solano, and the city of Berkeley, said they agree with findings that the vaccine is safe and the risk of developing the rare clotting disorder is extremely low.

Sunday's statement from the health officers recommends Bay Area health providers resume administering the Johnson & Johnson vaccine in an effort to prevent community spread and severe illness and death from COVID-19.

San Mateo County officials said on Friday they will follow all safety guidelines from the state and federal authorities. The county has 1,220 doses of Janssen/Johnson & Johnson on hand and will begin to integrate the vaccine back into its plans, a spokesman said on behalf of the county.

Anyone who has received the Johnson & Johnson vaccine should contact their primary health care provider if they have concerns or if they develop severe symptoms of headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination, the health officers said.

The single-dose Johnson & Johnson vaccine was considered an important component in getting shots in the arms of residents, particularly those who might balk at the two-shot regimen, which is given about 21 to 28 days apart. The vaccine also was considered an important breakthrough for people who are homeless or are homebound and can't easily access the two-shot regimen, county officials have said. The Janssen vaccine is also stored at higher freezer temperatures than the Pfizer and Moderna vaccines, facilitating its distribution without need for more specialized freezers.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

Bay City News Service contributed to this report.

Comments

chini
Registered user
Midtown
on Apr 24, 2021 at 10:08 am
chini, Midtown
Registered user
on Apr 24, 2021 at 10:08 am

The CDC, FDA took an extra week and came back with the statistics that was known going in - was hoping for some scientific studies or analysis correlating people who experienced blood clots but there was none.
My research found similar blood disorders reported from other vaccines as well:
Medpagetoday: Vaccines and Rare Clotting Disorders: What's the Link?Web Link
NYTimes A Few Covid Vaccine Recipients Developed a Rare Blood Disorder
Web Link

We were lucky to have gotten single-shot J&J one day before it was "paused". The misinformation, half-cooked reports were as confusing then as it is now, so I did my own research and risk evaluation and left the rest to the person up above. J&J, to me was the fastest way to get vaccinated.

It would be interesting to get a breakdown by vaccine type of the breakthrough cases reported so far instead of just a probability.

Bottom line: Talk to your doctor, get vaccinated, protect yourself and others! That's the only way to beat this disease.


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