Johnson & Johnson’s Vaccine is Approved. What Happens Now?

With federal approval, Virginia officials now decide how to use Johnson & Johnson’s vaccine.

RICHMOND – On Feb. 27, the Food and Drug Administration (FDA) issued Emergency Use Authorization for a third COVID-19 vaccine, this one produced by Janssen Biotech, Inc. Janssen is a pharmaceutical company of Johnson & Johnson. Unlike the Pfizer and Moderna versions, Johnson & Johnson’s vaccine requires only one dose to be effective. According to state and federal scientific leadership, this third vaccine strengthens the country’s ability to contain the pandemic. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock. 

The Virginia Hospital & Healthcare Association celebrated the addition of the Johnson & Johnson vaccine to the state’s arsenal. The EUA, the association said, “should result in a significant increase in federal distributions to the Commonwealth in support of expanded efforts to achieve a critical mass of vaccinated Virginians as quickly as possible.”

More Doses for Virginia 

According to the Virginia Department of Health, Virginia is expected to receive 69,000 doses of Johnson & Johnson’s vaccine this week. An additional, separate allotment will be sent directly to pharmacies, such as CVS and Walgreens, that are part of the federal partnership to increase vaccination. 

A Feb. 27 press release from VDH said these doses would “be prioritized for mass vaccination clinics across the state.” However, Dena Potter, director of communications for the state’s Department of General Services, told Dogwood on March 1 that the state is “continuing to work through the details” of where exactly the doses will be sent.  

Potter also clarified that the 69,000 doses Virginia will receive this week is not expected to be the state’s regular allotment.

“We expect that (number) to fall off after this week, but then pick back up again in a few weeks, after production is ramped up,” Potter said. 

In its press release, the VHHA cited Johnson & Johnson’s pledge to deliver 20 million doses by the end of March. If the company meets that benchmark, VHHA said, “Virginia could receive as many as 500,000 additional doses in the coming weeks if the vaccine allocation formula continues to be based on population.”

According to the association, Virginia’s health systems established community vaccination clinics throughout the Commonwealth. Collectively, those have the capacity to administer about 225,000 doses a week. The limiting factor thus far has been supply.

Is the Vaccine Safe?

Yes, the Johnson & Johnson vaccine is safe. Vaccines that are authorized for emergency use go through rigorous trials for efficacy and safety. The Johnson & Johnson vaccine was tested for effectiveness through an ongoing randomized, placebo-controlled study that included nearly 40,000 participants. The study was conducted across populations in South Africa, South America, Mexico and the United States. This means officials also tested the vaccine against new, more contagious variants of the virus.

The data found that the one-dose vaccine is about 67% effective overall at preventing moderate to severe illness from COVID-19 two weeks after the vaccine is administered—but closer to 72% effective in the United States. 

In terms of safety, the vaccine was found to produce only moderate side effects. According to the FDA, the most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most side effects lasted only a day or two.

How is it Different from Other Vaccines?

The Johnson & Johnson vaccine does differ from its Moderna and Pfizer peers in a couple ways. The one-dose shot is slightly less effective than the other two vaccines. Pfizer and Moderna’s vaccines boast efficacy rates close to 95%. 

That said, experts have been clear that people should accept any vaccine that is offered to them. “If someone prefers the two-dose option they can simply say they would rather stay on the pre-registration list and await an opportunity for one of those options,” Potter explained. “We understand people may have preferences, but we want to make sure everyone understands that all three vaccines have been proven to protect against serious illness, hospitalization and death from COVID-19, and the best vaccine for you will be the one that is available first.”

Another key difference between the vaccines is that while the Pfizer and Moderna vaccines utilize mRNA technology, the Johnson & Johnson vaccine delivers DNA via an adenovirus. The ultimate function of all three vaccines is very similar, though. None of the vaccines contain active coronavirus and none of them can infect you. They all give your body instructions to manufacture a COVID-19 “spike protein,” which mimics the virus and teaches your immune system how to fight it. 

Vaccine Will Be Distributed Across State

Because the Johnson & Johnson vaccine uses DNA instead of mRNA, it is more stable than the other vaccines. Potter explained that this means “the Johnson & Johnson vaccine is easier to store than the other two vaccines authorized for use in the U.S.” This could make the vaccine a good candidate for clinics in rural areas, since vaccines must be transported long distances to those clinics. However, Potter said, the Johnson & Johnson vaccine won’t be contained to rural areas. It will be distributed across the state. 

She added that it won’t be administered to any specific subset of the population. “We don’t plan to prioritize this vaccine for any certain demographic or area of the Commonwealth,” Potter said.

In fact, the Feb. 27 press release from VDH indicated that doses of the Johnson & Johnson vaccine will simply be added to health districts’ existing allocations. While Potter said details are still in flux, it sounds like folks with appointments could receive any of the three vaccines and will be given further instructions after their first dose. “VDH encourages all providers who schedule vaccine appointments to advise individuals which vaccine they will receive,” the press release said, so patients know whether a second appointment is necessary.