FDA Claims J&J's Single-Shot of COVID-19 Vaccine is Safe, Effective

Johnson & Johnson's (J&J) COVID-19 vaccine is safe and effective and could give Americans access to the first single-shot to work against the virus.

FDA: J&J COVID-19 single-shot vaccine has no safety issues

Eastern Colorado VA Receives Shipments Of Covid-19 Vaccines

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AURORA, CO - DECEMBER 15: (EDITORIAL USE ONLY) Rocky Mountain Regional VA Medical Center investigational pharmacy technician Sara Berech is reflected in the glass of a fume hood as she prepares a dose of the Johnson & Johnson COVID-19 vaccine for a clinical trial on December 15, 2020 in Aurora, Colorado. The Johnson & Johnson vaccine could be submitted for emergency use by late January and is the only vaccine among leading candidates given as a single dose.

The Food and Drug Administration (FDA) authorized Pfizer Inc. and Moderna Inc. COVID-19 vaccine in December 2020, before the first major COVId-19 variants were seen in the United States. Since then, coronavirus variants have become a significant concern. The J & J vaccine was less effective in Latin America and South Africa, where two mutant spreading versions were identified. The first variant arose in the UK called B.1.1.7 and seems to have a higher US level.

According to Bloomberg on MSN, the FDA's analysis discovered that the J&J COVID-19 vaccine has a favorable safety profile. The staff noted no Covid-related deaths in the group of vaccinated volunteers, nor any safety concerns that would interrupt the emergency-use authorization. However, the agency lacked data to determine whether the J&J vaccine prevented asymptomatic cases, the report said.

J&J' COVID-19 vaccine would become the world's first one-dose

According to an analysis by US regulators Wednesday, J&J's single-shot vaccine protects against COVID-19, which sets the stage for a final decision on a new and easier-to-use shot to help defeat the pandemic.

The FDA's scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19. The agency also said that it is safe to use J&J's shot to help speed vaccinations by requiring only one dose instead of two.

That's just FDA's one step in determining a third vaccine option for the US, as per NBC San Diego. The agency's independent advisers will debate on Friday if the evidence is strong enough to recommend the long-anticipated shot. A final decision is expected to be made by the FDA within days.

As the country mourns more than 500,000 virus-related deaths, the vaccination drive has been slower than expected, hampered by logistical issues and weather delays. Approximately 65 million Americans have received at least one dose of Pfizer or Moderna vaccine so far, shots that require two doses several weeks apart for complete protection.

Nearly 44,000 people in the US, South Africa, and Latin America went on J&J vaccine testing on its single-dose option. Researchers interpreted the findings internationally since various mutant forms of the virus are circulating in different countries. J&J recently reported that the vaccine performed well in the United States-72% successful against mild to extreme COVID-19, compared to 66% in Latin America and 57% in South Africa.

Still, it was highly successful against the most extreme symptoms in any country, and early study results showed no hospitalizations or deaths within 28 days after vaccination. While the overall efficacy figures may indicate that the J&J COVID-19 vaccine is not as good as two-dose rivals, all vaccines in the world have been studied differently, making comparisons almost impossible.

Although it would not be shocking if one dose turned out to be a little less than two doses, policymakers would determine whether to have more people vaccinated more quickly if that's an appropriate trade-off. J&J is set to become the world's first single-shot COVID-19 vaccine option until earlier this month. Meanwhile, Mexico announced that it would use a singer-shot version from China's CanSino. The CanSino vaccine is made with the same technology as J&J's. However, it developed a two-dose option until the start of a single-shot test in the fall.

If the FDA clears the J&J COVID-19 shot for US distribution, it won't improve vaccine supplies significantly right away. In the first week, only a few million doses are anticipated to be available for shipping. But J&J told Congress this week that by the end of March, it planned to have 20 million doses and 100 million by summer.

J&J's one-shot COVID-19 vaccine nears authorization

The FDA claimed that there are no unforeseen safety issues regarding the single-dose COVID-19 vaccine candidate from J&J. According to Market Watch, there are some distinctions between these vaccines and the candidate for J&J's investigational COVID-19 vaccine. The product of J&J is adenovirus-based and is not like Pfizer's and Moderna's vaccines, which are based on mRNA. It does not require extra refrigeration and requires only one injection rather than two doses.

However, it was less successful than those vaccines in clinical trials. 5 The Phase 3 clinical trial showed that in all countries where it was tested, J&J's vaccine candidate had an efficacy rate of 66.1%, compared with the approximately 95% efficacy rates recorded by the other vaccines in their late-stage trials. In the report, the FDA noted that the vaccine candidate has a "favorable safety profile with no specific safety issues found that would prevent an EUA from being issued."