April 24, 2021
Philadelphia has jumpstarted the administration of Johnson & Johnson's coronavirus vaccine after U.S. health regulators lifted Friday their recommended pause on distributing the New Jersey-based pharmaceutical company's one-dose vaccine.
The city notified its vaccine partners late Friday night that distribution of Johnson & Johnson's COVID-19 vaccine could resume, a spokesperson for the Department of Public Health told PhillyVoice.
Pennsylvania and New Jersey health officials also informed vaccination sites across both states Friday that the administration of Johnson & Johnson's one-shot COVID-19 vaccine could continue.
“We continue to urge individuals to get vaccinated as soon as possible with any of the three vaccines available to them," Pennsylvania's Acting Secretary of Health Alison Beam said. "Getting vaccinated is essential as we work to prevent the spread of COVID-19, and also of serious and fatal complications due to the virus.”
Today DOH notified all COVID-19 vaccine providers that the pause in administering doses of the Johnson & Johnson (Janssen) vaccine has been lifted. The move follows updated guidance announced today by @CDCgov and @US_FDA. Read more: https://t.co/bvnzkqYI5f pic.twitter.com/eAH5WeIMt6— PA Department of Health (@PAHealthDept) April 24, 2021
The Department tonight will notify vaccination Points of Dispensing that we are providing them with updated FDA fact sheets for patients and providers and that they may resume administration of the one-dose vaccine.— NJDOH (@NJDeptofHealth) April 24, 2021
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration encouraged states Friday to resume administering Johnson & Johnson's COVID-19 vaccine, affirming that the vaccine is safe and effective in preventing the coronavirus.
The decision came following a recommendation by the CDC's independent Advisory Committee on Immunization Practices, which met Friday and voted in favor of allowing Johnson & Johnson's COVID-19 vaccine back onto market in the U.S.
The available data that was examined found the vaccine's benefits outweigh the risks in adults, and that any chance of blood clots and low platelet counts occurring is very low, federal health officials said.
"We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality," Acting FDA Commissioner Dr. Janet Woodcock said. "We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."
“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr. Rochelle Walensky said. “Our vaccine safety systems are working."
"As we always do, we will continue to watch all signals closely as more Americans are vaccinated," Walensky continued. "I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization and death."
The CDC and FDA advised states earlier this month to stop using Johnson & Johnson's COVID-19 vaccine as federal health regulators reviewed a "rare and severe" form of blood clots and low platelet counts that had initially appeared in six out of 6.8 million Americans who received the shot.
Philadelphia, as well as Pennsylvania and New Jersey, followed suit and immediately suspended distribution of the vaccine.
A total of 15 cases of this type of blood clot, called cerebral venous sinus thrombosis, have been reported, federal health officials said Friday. All 15 adverse events occurred in women between the ages of 18-59 with a median age of 37 years old. Symptom onset took place between 6-15 days following vaccination.
Among those who developed blood clots and low platelet counts was a 26-year-old Pennsylvania woman who was hospitalized in New Jersey. The woman, a fitness instructor, had no history of blood clots.
A similar issue was identified in AstraZeneca's COVID-19 vaccine in Europe. Earlier this week, European health regulators issued a recommendation to countries that they should also begin distributing Johnson and Johnson's COVID-19 vaccine.
"As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere," Johnson & Johnson's Chief Scientific Officer Paul Stoffels said Friday.
"We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively."
Anyone who received Johnson & Johnson's COVID-19 vaccine and develops severe headache, abdominal pain, chest pain, swelling in the leg, shortness of breath, tiny blood spots under the skin or excessive bruising within two weeks after vaccination should contact their health care provider.
Johnson & Johnson's vaccine received an emergency use authorization from the FDA in February. The vaccine was 66% effective at preventing moderate to severe COVID-19 in clinical trials — an efficacy rating significantly lower than those produced by the Pfizer and Moderna vaccines.
But it was 85% effective at preventing severe illnesses. Health experts have stressed that the vaccine has proven highly effective at preventing hospitalizations and deaths.
Of the 20,000 participants who received the vaccine in the 40,000-person study, not one was hospitalized with COVID-19 in the months that followed. None of them died of the coronavirus.
An FDA analysis found the vaccine to be safe and effective. The most common adverse reactions were injection site pain, headache, fatigue and muscle pain.
However, this was not the first hiccup in the distribution of Johnson & Johnson's COVID-19 vaccine in the U.S. Earlier this month, about 15 million doses had to be thrown out after they were contaminated during production at the Baltimore-based plant Emergent BioSolutions, one of the company's contract manufacturers.