J&J: Second COVID shot boosts effectiveness by 94%
pharmafile | September 22, 2021 | News story | Medical Communications, Research and Development |
Johnson & Johnson have released data showing that a second dose of their one shot COVID-19 vaccine boosts protection from moderate to severe COVID to 94%, an increase of 24% from a single shot.
The data announcement from J&J comes at a crucial time for US President Joe Biden, as he pushes for booster shots in the face of surging hospitalisations caused by the Delta variant.
J&J has faced mounting pressure in the US to provide this data, as the only approved single shot vaccine producer.
Dr Paul Stoffels, J&J’s Chief Scientific Officer, said in a statement that the company has now “generated evidence that a booster shot further increases protection against COVID-19”.
A Phase III two-dose trial of up to 30,000 participants tested the effectiveness of a second dose given 56 days after the first in adults aged 18 and older.
J&J said a booster given two months after the first dose increased antibody levels four to six-fold, and when given six months after the first dose, antibody levels shot up twelve-fold.
While the study found that two doses of the J&J vaccine was 94% effective in the United States at preventing moderate to severe disease, there was only one case of COVID-19 in the vaccine group and 14 in the placebo group, resulting in a wide confidence interval and raising questions about the certainty of the result.
The study only had a follow up interval of 36 days and the data is yet to be peer reviewed, but is still set to be submitted for publication in the coming months.
Side effects with two doses of the vaccine were comparable to those seen in studies with the single-dose vaccine.
To date, only Pfizer/BioNTech have submitted sufficient data for US regulators to evaluate whether boosters are warranted ahead of the Biden Administration’s 20 September deadline for rolling out booster shots. A decision on that vaccine is expected this week.
On Friday, an FDA advisory committee voted to recommend emergency authorisation of additional Pfizer shots for Americans aged 65 and over and those at high risk of severe illness, but voted to recommend against broader approval, saying they want to see more data.
J&J has submitted data to the FDA and plans to submit it to other regulators, including the WHO and other vaccine advisory groups worldwide, to inform their decision-making on a booster shot.
Kat Jenkins
