On Tuesday, Johnson & Johnson (J&J) stated that the second dosage of their COVID-19 vaccine, given two months after the first, increased its effectiveness against moderate to severe disease in the United States to 94 percent. The booster was well tolerated, with side effects similar to those seen following the initial dose.
According to the company’s press statement, findings from a phase 3 US clinical research showed that a 56-day booster dose provided 94 percent protection against moderate to severe illness in nearly 30,000 adult participants. However, the confidence interval (CI) was significant, ranging from 58 percent to 100 percent, casting doubt on the result’s precision, per CIDRAP.
Experts Want More Data
Antibody levels quadrupled when a booster dosage was given after 56 days, and they soared 12-fold when the booster was given at six months, according to J&J. The average time between follow-ups was 36 days. The data has not been peer-reviewed, but the corporation has stated that it will publish them soon.
Paul Stoffels, MD, J&J chief scientific officer, said in a statement that they now have evidence that a booster shot boosts COVID-19 protection and projects to extend the period of protection considerably.
Some specialists, such as Florian Krammer, Ph.D., of Mount Sinai’s Icahn School of Medicine, have criticized the press release for lacking data. Moreover, he tweeted that he would like to see from J&J is data on efficacy over time, delta-specific data, and evidence on efficacy/effectiveness against infection and mild illness.
J&J disclosed as it prepares to apply to the FDA for emergency-use authorization for a booster dose. According to the firm, it has submitted data to the FDA. It will share it with other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups to inform local vaccination efforts.
Last month, the Biden administration announced that Americans who received the Pfizer/BioNTech COVID-19 vaccination would be eligible for additional doses. However, while FDA advisors agreed on Friday to recommend approval of booster dosages for high-risk and older Americans (65 and up), they acknowledged they required more data before recommending widespread clearance. This vaccination is anticipated to be voted approved by the FDA this week.
WHO Asks To Delay Booster Shots
The World Health Organization has encouraged wealthy countries to delay giving booster shots to their citizens until at least the end of December to share dosages with Africa, where they are in low supply. In a commentary published in The Lancet on September 13, experts from the WHO and the FDA stated that extra doses should be diverted to those most in need rather than those already well protected.
Despite the lack of a J&J booster, the company cites a second real-world trial of 390,000 Americans that shows the vaccine’s efficacy after just one dosage. In comparison to an unvaccinated control group of 1.52 million similar Americans, the single dose had 79 percent (95 percent CI, 77 percent to 80 percent) effectiveness against SARS-CoV-2 infection and 81 percent (95 percent CI, 79 percent to 84 percent) effectiveness against hospitalization at least 28 days later, according to the non-peer-reviewed study.
Vaccines less than 60 years old had 86 percent effectiveness against hospitalization, whereas those 60 and older had 78 percent. According to the announcement, vaccine effectiveness did not decline from March to July, even in response to the more transmissible Delta (B1617.2) version.