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Johnson & Johnson Evaluates COVID-19 Vaccine Against New Variant
In other COVID news, Moderna updates its strategy to address the new variant, Omicron, and Thermo Fisher finds that two of its COVID-19 tests detect Omicron.
Johnson & Johnson recently announced that it will evaluate its COVID-19 vaccine against the new and rapidly spreading Omicron variant.
Specifically, Johnson & Johnson is testing blood serum from participants in completed and ongoing booster studies to uncover neutralizing activity against the variant. The company is also creating an Omicron-specific variant vaccine and will progress it as needed.
“The new Omicron variant highlights the importance of continued surveillance, testing and vaccination to prevent hospitalizations and deaths from COVID-19,” Mathai Mammen, MD, PhD, global head of research & development at Johnson & Johnson, said in the announcement.
“We remain confident in the robust humoral and cell-mediated immune responses elicited by the Johnson & Johnson COVID-19 vaccine demonstrated by the durability and breadth of protection against variants to date in clinical studies,” Mammen continued.
In March, FDA authorized Johnson & Johnson’s COVID-19 vaccine for individuals 18 years and older. And at the end of October, FDA authorized the company’s vaccine booster for all eligible individuals who receive any authorized vaccine.
Johnson & Johnson continues to submit data to other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) globally to inform decision-making.
Moderna Updates Strategy to Address Omicron Variant
Moderna recently updated its strategy to address SARS-CoV-2 variants of concern due to the emergence of the Omicron variant.
The Omicron variant includes mutations in the Delta variant that may increase transmissibility and mutations seen in both the Beta and Delta variants that may promote immune escape.
First, Moderna has already tested a higher dose booster of its COVID-19 vaccine, mRNA-1273, in healthy adults. The company is testing sera from its high-dose booster recipients in neutralizing assays to determine if the 100 microgram dose provides superior neutralizing protection against the Omicron variant.
Second, Moderna is studying two multi-valent booster candidates in the clinical designed to anticipate mutations, including those that have emerged in the Omicron variant.
The first candidate includes several mutations in the Omicron variant that were also present in the Beta variant of concern, while the second candidate includes mutations present in the Omicron variant that were also present in the Beta and Delta variants.
And third, Moderna will rapidly advance an Omicron-specific booster candidate.
“From the beginning, we have said that as we seek to defeat the pandemic, it is imperative that we are proactive as the virus evolves. The mutations in the Omicron variant are concerning and for several days, we have been moving as fast as possible to execute our strategy to address this variant,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
Thermo Fisher’s COVID-19 Test Detects Omicron Variant
Thermo Fisher Scientific recently confirmed that its two PCR TaqPath COVID-19 test kits are not impacted by the emerging Omicron variant, enabling accurate test results.
The company’s TaqPath COVID-19 Combo Kit and TaqPath CE-IVD RT-PCR Kit currently test for the presence of SARS-CoV-2 by identifying three gene targets from the orf1a/b, S, and N regions of the virus.
The test can report accurate results even when one of the targets is impacted by mutation. Overall, neither test is impacted by any of the mutations in the Omicron variant, based on an assessment of sequences in the GISAID public database.
“The Thermo Fisher test allowed us to detect cases that may contain the new variant by identifying samples exhibiting S-gene dropout,” Tulio de Oliveira, director of the Centre for Epidemic Response and Innovation (CERI), Stellenbosch University and UKZN, South Africa, said in the announcement.
“This early identification is very important in helping us track and understand the spread of the B.1.1.529 variant to South Africa and the world,” Oliveira continued.
The WHO designated the Omicron variant a "variant of concern.” Omicron has 30 mutations in the spike protein alone and an increased risk of transmission compared to other variants of concern.
In addition to the original TaqPath COVID-19 tests, Thermo Fisher developed the TaqPath COVID-19 2.0 tests with an advanced assay design to compensate for emerging mutations.
