A third coronavirus vaccine could be heading to Georgia as early as next week, a move that could ease supply constraints and bring the state one step closer to bringing the COVID-19 pandemic under control.
After a daylong meeting Friday, an advisory committee for The U.S. Food and Drug Administration, in a unanimous vote, recommended emergency use authorization be granted for Johnson & Johnson’s single-dose COVID-19 vaccine for adults.
The FDA followed the committee’s endorsement, announcing Saturday evening that the agency had issued an emergency use authorization for the third vaccine for the prevention of COVID-19.
Later Saturday after the FDA’s announcement, Georgia Gov. Brian Kemp released a statement that the state “will receive approximately 83,000 doses of the new Johnson & Johnson single-dose vaccine in the first week.”
“This single-dose, effective Johnson & Johnson COVID-19 vaccine will significantly increase the state’s ability to safely and efficiently vaccinate more Georgians,” Kemp said in the statement, adding that “our goal is to get those vaccines administered as quickly as possible.”
“This is a game-changer,” said Jimmy Lewis, chief executive officer of HomeTown Health, an advocacy group for rural hospitals in Georgia. “To go from two vaccines to three is a tremendous boon for capacity. This is huge, for rural hospitals but also any hospital system, and this will make it easier to reach more people throughout the state in pharmacies and other providers.”
Because the J&J vaccine can be stored in a refrigerator for at least three months, it will be less challenging to distribute in areas without access to specialized, sub-zero freezers required for the two vaccines authorized late last year. It also has the advantage of being given in a single shot, instead of two.
Johnson & Johnson had said it will have 4 million doses available to ship as soon as the vaccine is authorized. Though that will barely make a dent in the vaccine shortage, supply is expected to ramp up quickly. Company officials say they can have 20 million doses available to the U.S. government by the end of March. The U.S. has agreed to buy 100 million doses of the vaccine by June.
It’s also not immediately clear where it would be distributed in Georgia, but Department of Public Health spokeswoman Nancy Nydam said the availability of a third COVID vaccine will help allow expansion of vaccination to those eligible throughout the state. She said DPH will place orders based on the allocation from the federal government once Johnson & Johnson vaccine receives the anticipated authorization.
Georgia desperately needs more vaccine supply, especially with a new plan taking effect on March 8 that expands eligibility to teachers and school employees, along with a group of “medically fragile” residents. Officials said this will add an estimated 1 million more people to the vaccine pool.
The state already allows those who are 65 and older and their caregivers, first responders, health care workers, and staffers and residents of long-term care facilities to receive the vaccine. About 57% of older Georgians have received at least one dose of the two-dose regimen of the vaccines authorized so far, Gov. Brian Kemp has said.
The success of the plan to expand eligibility also hinges on hopes that the state’s vaccine allotment will continue to rise. Georgia now receives about 215,000 first doses of vaccine a week, up from about 150,000 earlier this month. The White House said this week that weekly shipments of coronavirus vaccines nationwide will rise to 14.5 million, as vaccine manufacturers continue to ramp up production. That’s up from 8.6 million when President Joe Biden took office.
At first glance, the Johnson & Johnson vaccine doesn’t appear to be as stellar as FDA authorized vaccines from Pfizer-BioNTech and Moderna, which have an overall efficacy rate of 95%.
In clinical trials, the Johnson & Johnson vaccine had a 72% overall efficacy rate in the United States and 64% in South Africa, where a highly contagious variant emerged. The vaccine showed 86% efficacy against severe forms of COVID-19 in the U.S. and 82% against severe disease in South Africa.
But Kaiser Permanente of Georgia epidemiologist Dr. Felipe Lobelo, a former CDC officer, noted that results from Johnson & Johnson’s clinical trials have shown the vaccine to be 100% effective at preventing hospitalizations and deaths.
“I think the message we need to focus on is we are in survival mode and these vaccines will help us stay alive,” he said.
The Johnson & Johnson also appears to have milder side effects.
Like other vaccines, questions remain about how long immunity would last.
While Johnson & Johnson is confident that its one-dose vaccine can protect against COVID-19, the company started a trial last year to test out a two-dose schedule to see whether that would provide even greater or longer protection.
While some committee members expressed concern about adding another vaccine dose down the road causing logistical challenges as well as confusion in the public, others said the situation is fluid, and there may be needs for booster vaccines for all of the vaccines down the road.
Committee members also raised questions about the vaccine’s effectiveness among older adults with comorbidities. The company’s limited data on how well the vaccine protects people over 60 years old with risk factors — conditions such as heart problems and diabetes — suggests the vaccine may be only about 42 percent effective. Both FDA and the manufacturer noted that the statistical significance of that finding was uncertain, and no deaths or cases requiring medical intervention were reported a month after those older adults were vaccinated.
Professor Baozhong Wang at Georgia State’s Institute for Biomedical Sciences said we are in a race against time to vaccinate as many people as possible before new COVID-19 variants take hold. He said he doesn’t see the vaccine as inferior, but rather different, with the J&J vaccine offering important benefits as a single-dose vaccine with more lax storage requirements.
Over time, he said there will be a better understanding of the differences among the vaccines. But for now, he and others stressed, even if a vaccine is not 100% effective, it can still be an important tool in the fight against the virus. He and others also pointed to the flu vaccine, which is generally only 40% to 60% effective but is recommended every year as a way to reduce severe flu illness and deaths.
Dr. Colleen Kraft, an infectious disease physician and associate chief medical officer at Emory University Hospital, said as someone who spends “an inordinate amount of time” taking care of people with severe COVID-19 disease, the vaccine is a welcome development. “I think we are past the point of being overly academic about whether one is better or not,” she said.
“We need all of the vaccines because otherwise, this could take years to end, and there is a role for all of the vaccines to help us fight our way out of the pandemic,” he said.