Zacks analyst blog spotlights Pfizer, BioNTec and Moderna
For immediate release
Chicago, IL – July 5, 2022 – Zacks.com announces the list of stocks featured in the analyst blog. Every day, Zacks Equity Research analysts discuss the latest news and events impacting stocks and financial markets. Stocks recently featured in the blog include: Pfizer PFE/BioNTech BNTX and Moderna MRNA.
Here are highlights from Friday’s analyst blog:
FDA recommends adding new Omicron subvariants to Covid boosters
On June 30, the FDA recommended that COVID-19 vaccine manufacturers develop bivalent (or two-component) COVID-19 booster vaccines, which will target Omicron’s new subvariants, namely BA.4 and BA. .5.
The FDA recommendation is based on the recently convened meeting of the Vaccines and Related Biologicals Advisory Committee (VRBPAC) held earlier this week. voted in favor of inclusion a component of the Omicron variant in COVID-19 booster vaccines for use later this year.
As a result of this new recommendation, vaccine manufacturers like Pfizer /BioNTech and Modern would be required to modify the design of their respective vaccine boosters to target the Omicron BA.4 and BA.5 subvariants.
The FDA plans to begin administering these new vaccines later this year, in early to mid-fall. However, vaccine manufacturers should begin clinical studies on these vaccines and submit the required data to the FDA for evaluation before obtaining approval to use them.
Currently, BA.4 and BA.5 are the dominant subvariants of Omicron, which are responsible for more than half of all COVID-19 cases in the United States. Additionally, both of these subvariants outperform the BA.1 Omicron subvariant and have shown the potential to evade immune protection. This creates a need for tailored vaccine boosters with improved vaccine efficacy.
For now, the FDA has also asked vaccine manufacturers not to modify their vaccines for the primary series, because the administration of a primary regimen provides a basis for protection against the serious consequences (hospitalization and death) caused by the circulating strains of COVID-19.
Although the administration of a primary vaccination regimen has helped reduce the serious consequences caused by the variants of COVID-19, clinical studies have shown that antibody levels decrease over time. While the permitted booster doses restored these antibodies to their previous levels, this protection also weakens over time. Consequently, there is a huge need for booster doses, which offer protection against new emerging variants and thus prevent the serious consequences caused by the disease.
The currently licensed/approved vaccines marketed by Pfizer with its partners BioNTech and Moderna and their currently available boosters are designed to target the ancestral strain of coronavirus that emerged in late 2019. However, Pfizer/BioNTech and Moderna are developing a COVID-19 vaccine based on Omicron boosters to accommodate the rise of new and evolving Omicron sub-variants. These Omicron-targeted vaccines have shown promise in clinical studies.
Last month, Pfizer/BioNTech and Moderna announced positive data from their respective clinical studies, which are evaluating their respective Omicron-specific vaccine candidates. Data from these studies have already been reported to the FDA.
Moderna announced data from an ongoing Phase II/III study of its bivalent COVID-19 vaccine booster candidate, mRNA-1273.214, targeting the Omicron variant. Clinical data showed that after one month of administration of a 50 µg dose of mRNA-1273.214, a factor of 5.4 increase in neutralizing antibodies against Omicron BA.4 and BA.5 subvariants was observed in all study participants, regardless of prior infection. In a subset of seronegative participants, the candidate generated a 6.3-fold increase in neutralizing titers against both Omicron subvariants.
Pfizer and BioNTech are also working on new Omicron-based vaccine candidates, both monovalent and bivalent, in a phase II/III study. The bivalent vaccine is a combination of the ancestral strain and the Omicron BA.1 subvariant. Last month, the two companies announced data from this study, which showed that participants, given the booster dose of the two candidate vaccines, generated significantly higher immunity against Omicron’s BA.1 subvariant versus Comirnaty, Pfizer/BioNTech’s currently licensed vaccine.
Although monovalent and bivalent vaccine candidates from Pfizer and BioNTech effectively neutralized both subvariants, based on data from preliminary laboratory studies, the neutralizing titers generated upon dosing with both vaccine candidates were three times lower than the titers neutralizers against the BA.1 one variant.
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