Johnson & Johnson vaccine may provide critical aid

A wave of new COVID-19 vaccines appears to be on the horizon, bringing with them the expanded possibilities of reaching people outside traditional health care settings and with only one dose.

Two vaccines, from Pfizer/BioNTech and Moderna, have received emergency approval from the Federal Drug Administration.

Promising clinical trial data for vaccines developed by Oxford University/Astrazeneca and Novavax puts those on track for FDA approval as well.

At a time when ongoing logistical challenges and emerging new variants of the coronavirus continue to threaten the global push for mass immunization against COVID-19, a new vaccine from Johnson & Johnson could provide critical aid. 

The new vaccine developed by Johnson & Johnson, which has applied for FDA approval, could receive approval by the end of this month.

The vaccines are not the same. They were developed with different technologies, some must be stored at extreme temperatures while others don’t and, most importantly, they can require a different number of shots.

The Johnson & Johnson immunization has two advantages: it can be administered in a single dose, instead of two like the Moderna and Pfizer vaccines, and it requires simple refrigeration rather than sub-zero temperatures.

Experts and public health officials say all the vaccines have one big thing in common: they are immensely effective at preventing hospitalizations and severe bouts of COVID-19.

“It’s incredible,” said Dr. Buddy Creech, director of the Vanderbilt University Vaccine Research Program. “With the two vaccines we have under emergency use now, and with Johnson & Johnson, we now have three really good tools to curb the pandemic.”

“What I think is important to say is we have nearly 100 percent efficacy in clinical trials at preventing COVID-19-related hospitalization and death. And that is what will turn the tide,” said Creech.

Creech touted the efficacy of all three vaccines in response to a question about the most recent data from Johnson & Johnson, which showed 72 percent efficacy in preventing participants in the clinical trial from getting moderate to severe cases of the virus. The vaccine proved effective 28 days after being administered at preventing serious cases of COVID-19.

Although the Pfizer and Moderna vaccines, which use cutting-edge messenger RNA technology, are more effective at preventing moderate cases, health experts said people shouldn’t worry about shopping around for different vaccines.

The Johnson & Johnson vaccine also appeals to public health officials because it is administered in a single dose, unlike the current vaccines that need two.

The Johnson & Johnson vaccine is also simpler for the state and local health departments to handle because it can be stored in ordinary refrigerators.

“We anxiously await the Johnson & Johnson vaccine because it is a single dose, refrigerated vaccine,” said Dr. Michelle Fiscus, FAAP, medical director of the Tennessee Department of Health Vaccine-Preventable Diseases and Immunization Program. “A single dose vaccine is attractive because we currently spend so much effort providing second vaccine doses when we could be vaccinating more people. Vaccinating everyone once is much easier than vaccinating everyone twice.”

The Johnson & Johnson vaccine, which is under review by the Food and Drug Administration for emergency use authorization, is more effective against new variants than other vaccines and doesn’t require special freezers for storage or shipment. 

At 66 percent effective at preventing COVID-19 overall, the Johnson & Johnson vaccine is less effective than the Moderna and Pfizer vaccines. But still, the pros of this new vaccine far outweigh the cons, says Mansoor Amiji, university distinguished professor of pharmaceutical sciences and chemical engineering at Northeastern.

“This is such a devastating disease. The need for vaccinations is incredible, and being able to offer another vaccine candidate and ramp up production really trumps any of the concerns about efficacy,” says Amiji. 

Even at 66 percent overall efficacy, the Johnson & Johnson vaccine is considered a successful vaccine. The average flu vaccine usually hovers around 50 percent efficacy, Amiji says. Plus, 66 percent efficacy refers only to the overall results of the clinical trial. The Johnson & Johnson vaccine was 85 percent effective at preventing severe cases of COVID-19, and there were no deaths or hospitalizations among the group who received the vaccine in the clinical trials. 

“This is the challenge when we talk about efficacy. What endpoint are you using? For Johnson & Johnson, their definition was: How many people are diagnosed with symptomatic COVID-19? So even though the vaccine didn’t prevent symptomatic cases quite as well as the Moderna or Pfizer vaccines, it did a great job preventing hospitalizations and deaths,” says Brandon Dionne, assistant clinical professor in the School of Pharmacy at Northeastern.

The Johnson & Johnson vaccine can be stored at the temperature of a regular refrigerator for up to three months, making it more accessible to smaller doctor’s offices or neighborhood pharmacies that don’t have the ultracold freezers required to store other vaccines, such as Pfizer’s, at -94 Fahrenheit. 

Additionally, the less temperature-sensitive vaccine makes transportation easier. Many shipping trucks and planes are already outfitted with the technology required to refrigerate the Johnson & Johnson vaccine, Amiji says. 

“These vaccines have to reach large masses around the world,” says Amiji. “When we look at early distribution of vaccines, most of the effort has been to vaccinate the developed nations, but for this pandemic to come to a close, we have to think about going beyond those borders.” Fewer obstacles in shipping and storage could help the vaccine reach more remote areas. 

New variants of the virus, which have cropped up in the United Kingdom, South Africa, and Brazil, have created concern about whether the vaccines currently in distribution will continue to protect patients from new strains.

The variants from South Africa and Brazil, called B.1.351 and P.1 respectively, present the biggest challenges because of mutations that affect the same part of the virus—the spike protein—that the vaccines imitate to create immunity. 

The South African government recently suspended its plan to distribute the AstraZeneca vaccine after a study—though limited and not yet peer-reviewed—found the vaccine provided only “minimal protection” against B.1.351.  

Clinical trial data for the Johnson & Johnson vaccine, which were collected in multiple countries while new variants were already in circulation, showed the vaccine was 66 percent effective in South America, and 57 percent effective in South Africa

Lab results for the Moderna and Pfizer vaccines, which underwent clinical trials before these new variants emerged, show that both vaccines provide comparable protection against the U.K. variant, called B.1.1.7, but diminished efficacy against B.1.351 and P.1. 

But even with these results, researchers don’t know for certain how the Moderna or Pfizer vaccine interacts with the new variants. “You can’t fully mimic the immune system in a lab,” says Dionne. “Even though there seems to be reduced efficacy in the lab, we don’t really know how that plays out in the human body.”  

As a precaution, the companies are testing whether booster shots could increase protection against new variants. 

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