Two Novavax shots perform well in COVID-19 booster trial, company says
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Novavax on Monday said that its omicron subvariant vaccine candidate and original COVID-19 vaccine both performed well in a phase 3 trial testing three vaccines as a second booster dose.
The trial showed no benefit from a bivalent shot combining the two vaccines, suggesting that a bivalent booster is not needed because its vaccine can be updated when necessary, the company said.
Used as a fourth shot, Novavax’s original vaccine induced “a broad immune response” against the original strain of SARS-CoV-2, as well as the omicron BA.1 and BA.5 sublineages, the company said. Neutralizing responses were even greater among participants who received the BA.1 booster as a fourth shot compared with the original vaccine.
“Today’s results show that use of our [original] vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains,” Gregory M. Glenn, MD, president of research and development at Novavax, said in a press release, adding that the Novavax vaccine “presents a potential strategy to protect against COVID-19 now and into the future.”
The data released Monday were from 273 participants who received a booster dose of the original vaccine, 279 who received a BA.1 booster vaccine candidate and 277 who received a bivalent booster dose composed of the original vaccine and the BA.1 candidate.
Although all three groups showed similar immunoglobulin G antibody responses against the Wuhan and BA.1 variants, there was not a significant difference in efficacy against the BA.5 variant between the original Novavax vaccine, the BA.1 candidate or the bivalent vaccine, the company said.
When comparing neutralizing antibody responses among each of the three vaccine groups, the BA.1 booster vaccine induced a neutralizing response 1.6 times greater than the original vaccine among people not previously infected.
All three vaccine formulations were well tolerated, Novavax said, with the most common side effects among participants being pain or tenderness at the spot of injection, fatigue or malaise, headache, muscle pain and joint pain — and most reactions were mild or moderate.
The FDA in June authorized Novavax’s two-dose COVID-19 vaccine for adults. It authorized updated bivalent booster vaccines from Moderna and Pfizer-BioNTech in August. The two companies’ updated boosters target the original strain of SARS-CoV-2 as well as the omicron variant.
In October, the agency also authorized a booster shot of the original Novavax vaccine as an alternative to the messenger RNA vaccines.
References:
- NIH. Phase 3 boosting study for the SARS-CoV-2 rS variant vaccines. https://clinicaltrials.gov/ct2/show/NCT05372588. Accessed Nov. 8, 2022.
- Novavax phase 3 COVID-19 omicron trial supports the continued and future use of Novavax prototype vaccine as a booster. https://ir.novavax.com/2022-11-08-Novavax-Phase-3-COVID-19-Omicron-Trial-Supports-the-Continued-and-Future-Use-of-Novavax-Prototype-Vaccine-as-a-Booster. Published Nov. 8, 2022. Accessed Nov. 8, 2022.
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