Johnson & Johnson Coronavirus Vaccine Use Paused In Virginia

VIRGINIA — As the Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday due to blood clot concerns, Gov. Ralph Northam said Virginia will temporarily pause use.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Peter Marks of the FDA and Dr. Anne Schuchat of the CDC said in a joint statement.

As of Monday, more than 6.8 million doses of the single-dose vaccine have been administered in the United States, according to the FDA.

The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare," Marks and Schuchat said in the joint statement from the FDA and CDC. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

Dr. Danny Avula, Virginia's vaccine coordinator, said the Johnson & Johnson vaccine will be paused until the investigation is complete. Rollout of the Pfizer and Moderna vaccines will continue.

"We are closely monitoring the actions by the federal government to pause all Johnson & Johnson vaccinations while it investigates an extremely rare possible side effect," said Avula in a statement. "In Virginia, we will cease all Johnson & Johnson vaccines until this investigation is complete. If you have an upcoming appointment for the Johnson & Johnson vaccine, you will be contacted to reschedule that appointment."

SEE ALSO: Johnson & Johnson Vaccine Pause: 6 Things To Know

Several pharmacies offering vaccine scheduling also indicated the Johnson & Johnson vaccine won't be used temporarily. CVS said it is "immediately implementing a pause in the use of the Johnson and Johnson’s COVID-19 vaccine per the recommendation from federal health agencies." Wegmans indicated it canceled all Johnson & Johnson vaccine appointments and will pause use while CDC and FDA investigate. Walgreens also paused the vaccine and expects to have more details soon.

The CDC's Advisory Committee on Immunization Practices will meet Wednesday to further review the blood clot cases and assess their potential significance. The FDA will review that analysis as it also investigates.

"Until that process is complete, we are recommending this pause," officials said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

The move to pause use of the vaccine comes weeks after the FDA halted production of the J&J vaccine at a Baltimore facility run by Emergent BioSolutions following a mix-up in ingredients. However, the company said none of the 15 million doses that had been tainted were ever shipped out from the plant. That led to Virginia and other states expecting fewer doses in the coming weeks.

Blood Clot Prompts Investigation

The CDC and FDA issued a joint statement about the decision to stop using the J&J vaccine with more detail on the cases that prompted the investigation.

"COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," the statement said. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to the statement.

Officials said a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System.

Leaders from the CDC and FDA are providing additional information and answering questions at a media briefing at 10 a.m. that will be broadcast on YouTube. The FDA and CDC, addressed the issue during a 10 a.m. media call, saying the pause will likely be a "matter of days."

How the Johnson & Johnson Vaccine Works

There are three vaccines currently available in the United States — Pfizer, Moderna, and Johnson & Johnson.Both Pfizer and Moderna deliver mRNA — a genetic recipe that teaches your body how to build the spike protein found on the surface of the coronavirus. If the real virus enters the body, your immune system will recognize it and know how to fight it.

Johnson & Johnson, however, uses a different technology to prime the body to fight against COVID-19. Instead of mRNA, it utilizes an adenovirus — a common cold virus that cannot replicate and make a person sick once it enters the cells.

Ultimately, the cold virus will deliver the coronavirus-fighting genetic blueprint into the cells and teach the immune system how to recognize the spike protein found on the surface of the coronavirus.

Adenovirus vaccines can be refrigerated for up to three months at 36 to 46 degrees Fahrenheit, according to Johns Hopkins University.

Clinical trials showed the J&J vaccine as being less effective against the virus compared with the vaccines developed by Moderna and Pfizer. The company said the vaccine has a 72 percent efficacy rate among trial participants in the U.S., but is about 85 percent effective against the most severe forms of the virus. Moderna and Pfizer tout efficacy rates at or near 95 percent.

Johnson & Johnson's vaccine is for people 18 years old and up.

COVID-19 data

As of Tuesday, 3,157,257 people have at least one vaccine dose in Virginia, or 37 percent of the population. There are 1,853,400 fully vaccinated people, or 21.7 percent of the population. The state is averaging 72,958 doses administered per day.

On Tuesday, 2,048 new COVID-19 cases and 20 deaths were reported by VDH. It was the second day in March and April that daily cases were above 2,000; the other day was March 18. Cases had been trending down from January to early March before reaching a plateau. The seven-day daily case average is 1,615.

The seven-day average of positive PCR tests is stable at 6.1 percent as of April 9. On average 17,992 daily PCR testing encounters are reported across the state.

Virginia's COVID-19 hospitalizations stand at 1,070 statewide as of Tuesday. The current count includes 252 patients in intensive care units and 144 on ventilators.

Ventilator use among all hospital patients is at 28 percent, and ICU occupancy is at 77 percent, according to the Virginia Hospital & Healthcare Association.

Here are the latest coronavirus data updates for our coverage area from Monday to Tuesday:

• Alexandria: 11,348 cases, 545 hospitalizations, 130 deaths; increase of 23 cases
• Arlington County: 14,697 cases, 817 hospitalizations, 249 deaths; increase of 18 cases and one hospitalization
• Fairfax County: 73,751 cases, 3,805 hospitalizations, 1,055 deaths; increase of 231 cases, nine hospitalizations and one death
• Fairfax City: 532 cases, 46 hospitalizations, 18 deaths; increase of one case
• Falls Church: 406 cases, 20 hospitalizations, nine deaths; increase of two cases
• Loudoun County: 26,379 cases, 981 hospitalizations, 273 deaths; increase of 136 cases and seven hospitalizations
• Manassas: 4,242 cases, 169 hospitalizations, 45 deaths; increase of six cases
• Manassas Park: 1,177 cases, 68 hospitalizations, 12 deaths; no changes
• Prince William County: 43,368 cases, 1,577 hospitalizations, 477 deaths; increase of 127 cases and one hospitalization
• Fredericksburg: 1,961 cases, 98 hospitalizations, 22 deaths; increase of nine cases and one hospitalization
• Spotsylvania County: 9,230 cases, 299 hospitalizations, 110 deaths; increase of 26 cases and four hospitalizations
• Stafford County: 10,560 cases, 342 hospitalizations, 72 deaths; increase of 41 cases, two hospitalizations and one death

Patch editors Elizabeth Janney, Alessia Grunberger and Tom Davis contributed reporting.