Alyssa Billingsley, PharmD
March 1, 2021, 1:44PM (PT)
Key takeaways:
- The FDA has approved the emergency use authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine, making it the third to be authorized in the United States.
- The vaccine only requires one shot instead of two and has more conventional storage requirements, giving it a logistics advantage over the current vaccines.
- The first 3 million to 4 million doses of the vaccine are expected to ship out this week, with a goal of 20 million doses delivered by the end of March.
Over the weekend, the FDA approved the emergency use authorization (EUA) for Johnson & Johnson’s vaccine candidate, which was developed by its subsidiary, Janssen Biotech, Inc. The vaccine is the third candidate to be authorized in the United States, following the Pfizer and Moderna mRNA vaccines that were both authorized in December. Like the Moderna vaccine, it is authorized for use in people 18 years of age and older.
The Johnson & Johnson vaccine, which was co-funded in partnership with the Biomedical Advanced Research and Development Authority (BARDA), offers some advantages over the current vaccines. While its overall efficacy rate isn’t as high as the other vaccines, it only requires one shot, and it can be stored at refrigerator temperatures for at least 3 months.
Here we’ll cover what you need to know about the Johnson & Johnson vaccine, and when it will be available. If you’d like to learn more about emergency use authorization for vaccines, see the FDA’s page here.
What’s the difference between the Johnson & Johnson vaccine and the other authorized vaccines?
As the newest COVID-19 vaccine to be authorized for emergency use in the U.S., the Johnson & Johnson vaccine has some distinct characteristics that set it apart from the Pfizer and Moderna vaccines. Let’s review some notable differences.
How the vaccines work
The Pfizer and Moderna vaccines both use a technology called mRNA, or messenger RNA. The mRNA provides our cells with instructions on how to make the coronavirus’ spike protein, which helps us fight off a future infection. Unlike more traditional vaccines like the flu shot, mRNA vaccines do not contain a virus.
The Johnson & Johnson vaccine, on the other hand, uses an inactivated common cold virus called an adenovirus to carry a gene that instructs our cells to make the spike protein to cause an immune response. This is referred to as a viral vector. But don’t worry — the virus has been genetically engineered so that it can’t replicate and make you sick.
One of the challenges with viral vectors is that it’s possible that you’ve already been exposed to the virus being used in the vaccine. This means that you already have immunity to the virus, and that the vaccine may not work for you.
To navigate this challenge, researchers will use viruses that are less common (like the human adenovirus type 26 in this vaccine), or they may use viruses from other species. For example, the AstraZeneca vaccine uses an adenovirus from chimpanzees.
Efficacy rates
Overall, the Johnson & Johnson vaccine had a topline efficacy rate of 66% in preventing moderate to severe COVID-19 at least 28 days after vaccination. This is in contrast to Pfizer and Moderna’s efficacy rates (95% and 94%, respectively) against symptomatic COVID-19.
But these numbers aren’t quite like comparing apples to apples, since the trials were measuring different outcomes, and the emergence of coronavirus variants likely had an impact on results with the Johnson & Johnson vaccine. For example, almost all of the COVID-19 cases during the vaccine’s trial in South Africa were due to the B.1.351 variant, which may be better at escaping our immune system.
Even so, the Johnson & Johnson vaccine had an overall efficacy rate of 85% in preventing severe disease 28 days after vaccination, which includes over 80% efficacy in the regions where variants are more prevalent. And like the Pfizer and Moderna vaccines, it was also completely protective against hospitalization and death.
The bottom line is that all of the authorized vaccines work well at preventing severe disease, hospitalization, and death from COVID-19, which can help lower the burden on our healthcare system.
Dosing schedule
One major advantage of the Johnson & Johnson vaccine is that it only requires one shot. The Pfizer and Moderna vaccines both currently require two shots 3 or 4 weeks apart, respectively. This can add logistical challenges like reserving enough vaccines for a second dose and scheduling follow-up appointments.
As we work to vaccinate as many people as quickly as possible, Johnson & Johnson’s single-shot regimen will help vaccine allocations cover more people, expanding vaccination efforts faster.
Storage and handling
Previously, the Pfizer vaccine required ultra-cold storage, which involved special equipment at vaccination sites. However, the FDA now allows the vaccine to be transported and stored at freezer temperatures for up to 2 weeks. And while this change will help with distribution efforts, the vaccine still needs to be thawed and diluted, which starts a 6-hour clock for doses to be given before they need to be thrown away. Any thawed vials that haven’t been diluted can be stored in the refrigerator for up to 5 days.
The Moderna vaccine, on the other hand, does not need to be diluted. But since it arrives frozen, it’ll need to be thawed, too. Like the Pfizer vaccine, there is a 6-hour clock to use the doses but only if the vial has been punctured. Any thawed vials that haven’t been punctured can be stored in the refrigerator for up to 30 days.
But of the three vaccines, the Johnson & Johnson product is easier to transport, store, and handle. While it should remain stable at freezer temperatures for about 2 years, the vaccine can be stored at refrigerator temperatures for up to 3 months. However, the doses still need to be used within 6 hours after the vial has been punctured.
Does the vaccine work against the new virus variants?
So far, over 70% of samples from confirmed COVID-19 cases in the vaccine’s trial have been sequenced to identify any variants. Most of the cases in South Africa (94.5%) were from the B.1.351 variant, which was one of the notable new variants identified last fall that has since made its way to the United States.
The vaccine still provides protection against the B.1.351 variant, with 64% efficacy against moderate to severe/critical COVID-19 and 81.7% efficacy against severe/critical COVID-19 at least 28 days after the shot in South Africa.
But as far as the other emerging variants go, the B.1.1.7 that is prevalent in the United Kingdom and the P.1 variant identified in Brazil have not yet been seen in samples.
What was the testing process for the Johnson & Johnson vaccine?
The Johnson & Johnson vaccine went through the typical testing steps of a vaccine, including phase 1, 2, and 3 clinical trials. The trials included more than 40,000 participants in eight countries across three continents. And in the U.S. group, about 26% of participants were people of color.
The trial evaluated efficacy against moderate to severe/critical COVID-19 at two points: at least 14 days and 28 days after vaccination. Severe/critical COVID-19 cases were also evaluated at the same interval. Overall, the vaccine had the following efficacy rates:
At least 14 days after vaccination: 66.9% against moderate to severe/critical COVID-19 and 76.7% against severe/critical COVID-19. There were two hospitalizations in the vaccine group (29 in the placebo group).
At least 28 days after vaccination: 66.1% against moderate to severe/critical COVID-19 and 85.4% against severe/critical COVID-19. There were no hospitalizations in the vaccine group (16 in the placebo group).
According to the FDA briefing documents, the vaccine did not have any serious risks, and there weren’t specific safety concerns that would have prevented the vaccine authorization from being approved. Don’t miss out on savings!Get the best ways to save on your prescriptions delivered to your inbox. By signing up, I agree to GoodRx’s terms of service and privacy policy, and to receive marketing messages from GoodRx.
When can we get the Johnson & Johnson vaccine?
Johnson & Johnson announced in early August that they had reached an agreement with the U.S. government to supply 100 million doses of their vaccine, with the option to purchase an additional 200 million doses under another agreement. The company is expected to deliver the doses starting immediately after authorization through the end of June.
Now that the vaccine has been authorized, 3 million to 4 million doses are expected to ship out this week, according to a recent White House COVID-19 Response Team press briefing. Additionally, the company is aiming to deliver 20 million doses by the end of March.
What should I expect if I get the Johnson & Johnson vaccine?
The vaccine is currently authorized for use in people who are at least 18 years old, and it only requires one shot. According to the trials, protection from the vaccine was seen as soon as 14 days after getting the dose, with 66.1% overall efficacy against moderate to severe/critical COVID-19 at least 28 days after.
As with the other COVID-19 vaccines, you may experience some mild to moderate side effects after your shot. In the trials, people most commonly experienced injection site pain, fatigue, headache, nausea, and muscle aches that lasted for a day or two.
Who shouldn’t get the Johnson & Johnson vaccine?
People who have a history of severe allergic reactions (like anaphylaxis) to any of the vaccine’s ingredients should not get the Johnson & Johnson vaccine. You can find a list of the ingredients here.
And if you are pregnant or breastfeeding, or if you have a compromised immune system, you’ll want to discuss the benefits and risks of the vaccine with your healthcare provider.
What other vaccines are close to emergency use authorization?
A few other vaccines may be authorized sometime this year.
AstraZeneca
Similar to the Johnson & Johnson vaccine, the AstraZeneca candidate uses viral vector technology to deliver the spike protein instructions to our cells. Although it isn’t expected to be authorized in the U.S. until April, it is currently authorized for use in over 50 other countries.
The World Health Organization (WHO) also recently authorized the vaccine for emergency use, which helps to expand distribution into countries that don’t currently have access to COVID-19 vaccines.
Novavax
Rather than providing your cells with instructions on how to make the spike protein themselves, the Novavax vaccine candidate contains spike proteins from the coronavirus to trigger an immune response.
In late January, Novavax announced interim results from its phase 3 trial in the United Kingdom and its phase 2 trial in South Africa, reporting efficacy rates of 89.3% and 49.4%, respectively. The company has also just completed enrollment for trials in the U.S. and Mexico.
The bottom line
The authorization of Johnson & Johnson’s vaccine contributes another 100 million doses to the country’s vaccine supply, covering an additional 100 million people. The single-shot regimen has been shown to be highly effective in preventing severe disease, hospitalization, and death from COVID-19, making it an important tool in the fight against the coronavirus.
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