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Novavax’s COVID-19 Vaccine Booster Neutralizing Antibody Levels
In other COVID news, Australia grants provisional registration to Moderna’s COVID-19 vaccine and Thermo Fisher updates the SARS-CoV-2 mutation panel to detect various COVID-19 strains.
Novavax recently announced that a single booster dose of its COVID-19 vaccine, NVX-CoV2373, elicited a 4.6-fold increase in functional antibody titers six months after an initial two-dose regimen.
The Phase 2 study results showed that functional ACE-2 binding inhibition antibodies cross-reactive with the B.1.617.2 variant were over 6-fold higher than the primary vaccination series.
Additionally, anti-spike IgG increased nearly 4.6-fold compared to the peak response seen after the second dose. And wild-type neutralization responses increased about 4.3-fold compared to the peak response seen after Dose 2.
Overall, boosting NVX-CoV2373 elicited “very high levels” of functional antibodies to the B.1.1.7, B.1.351, and Delta variants, with a 6.6-fold higher Delta variant-specific response compared to the Delta response with the primary vaccination series.
“The continuation of our proactive clinical development program will be critical to understanding and demonstrating the effectiveness of our recombinant nanoparticle COVID-19 vaccine,” Gregory M. Glenn, MD, president of research and development at Novavax, said in the announcement.
NVX-CoV2373 is a protein-based vaccine candidate created from the genetic sequence of the first strain of SARS-CoV-2.
The ongoing Phase 2 study in the US and Australia selected certain participants in the 5-microgram dose cohort to receive a 5-microgram booster dose 189 days after the initial two-dose regimen.
The booster dose was generally well-tolerated, and local and systemic reactogenicity increased between the first, second, and third doses. Nearly 90 percent of symptoms were mild or moderate after the third dose.
Australia Grants Provisional Registration to Moderna’s COVID-19 Vaccine
Moderna recently announced that Australia’s Therapeutic Goods Administration (TGA) granted provisional registration to COVID-19 Vaccine Moderna for active immunization to prevent the coronavirus.
Vaccine delivery is expected in the second half of September 2021.
“I want to thank the government of Australia for their collaboration and for the confidence they have demonstrated in COVID-19 Vaccine Moderna with this decision,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“As we seek to protect people around the world with our COVID-19 vaccine, we look forward to continuing discussions with the Australian Government about potentially establishing local mRNA manufacturing capabilities,” Bancel continued.
In May, Moderna supplied the government of Australia with 25 million doses of its vaccine and booster variant candidate, mRNA-1273.51.
Ten million doses of the COVID-19 vaccine will be delivered in 2021, and 15 million doses of mRNA-1273.51 will be delivered in 2022.
Over 50 countries have granted emergency (or other conditional, interim or provisional) authorizations for Moderna’s COVID-19 vaccine, and the World Health Organization granted Emergency Use Listing (EUL) for the vaccine.
Thermo Fisher Updates SARS-CoV-2 Mutation Panel to Detect COVID-19 Strains
Thermo Fisher Scientific recently announced that it updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to detect the Delta and Lambda COVID-19 strains.
Last March, the company launched the research panel, which contains a customizable menu of verified real-time PCR assays to identify SARS-CoV-2 mutations.
The panel can run a few or hundreds of samples to identify one or many mutations, enabling laboratories to meet the need for multiple testing with real-time PCR instruments already in use.
The TaqMan SARS-CoV-2 Mutation Panel is based on SNP genotyping assay technology and provides results in about an hour, which helps detect and distinguish mutations efficiently, a Thermo Fisher spokesperson said.
“SARS-CoV-2 will continue to evolve, potentially creating an increased risk of infection in both vaccinated and unvaccinated individuals," Manoj Gandhi, senior medical director for genetic testing solutions at Thermo Fisher Scientific, said in the announcement.
“Surveillance testing is critical as we learn to live with this virus. Customizable panels like this are a convenient option to scale surveillance testing using existing PCR instruments, as well as provide results quickly so swift public health countermeasures can be implemented to limit the spread of the virus,” Gandhi concluded.
