The pharmaceutical giant Pfizer together with its German partner BioNTech have just published initial data from a preliminary study on the application of a third booster dose for its vaccine against COVID-19 that originally has two injections spaced every 3 weeks or 21 days.
As announced by the company, the third component given about six months after the second dose showed that the neutralization titers observed are five to ten times higher than those recorded with the two original inoculants.
The companies, which manufacture the inoculant based on messenger RNA technology, said they hope to publish “more definitive” data soon to present them to the US Food and Drug Administration, FDA.
Real-world evidence in Israel, Pfizer believes, showed a decrease in efficacy achieved about six months after people were fully vaccinated. This raised the need to study possible booster dose strategies.
In a press release, they warned: “While protection against serious illness remained high during the entire six months, the observed decrease in effectiveness against COVID-19 Asymptomatic over time and the appearance continuous variants are key factors driving our belief that a third booster dose will likely be necessary to maintain the highest levels of protection. ”
Even companies are working on materials with a plan to pass a new platform construction vaccine, designed for the Delta variant, given new clinical trials starting in August.
From the company, they insisted: “ Although we believe that the third dose of BNT162b2 – Pfizer’s technical name for the vaccine – has the potential to preserve the highest levels of protective efficacy against all currently known variants, including Delta, we remain vigilant and we are developing an updated version of the Pfizer-COVID-19 vaccine that uses a new platform based on the B.1.617.2 lineage, first identified in India and also known as the Delta variant. ”
“Companies are already producing clinical trial material and anticipate starting clinical studies in August, subject to regulatory approvals,” Pfizer and BioNTech said in the statement.
For its part, Moderna, the other inoculant that uses RNA technology and together with the Johnson & Johnson vaccine make up the triad of vaccines approved in the United States, have made statements along the same lines as Pfizer in recent days on the need for booster injections for its inoculant against COVID-19, which has two doses, every 4 weeks or 28 days; while the J&J is single-dose, that is, it only requires a single application.
In May, Stephane Bancel, Moderna’s CEO, warned: “Booster injections will be needed as we believe the virus will not go away,” along with investors.
The laboratories will have to carry out more studies so that the FDA and the Centers for Disease Control and Prevention of the United States (CDC) decide on the third dose and determine if they will allow the incorporation of the aforementioned booster into the schemes, and of course, explain how and when to apply them in each case.
Asked by ABC, Dr Dan Barouch, Director of Virology and Vaccine Research at Beth Israel Medical Center, “clearly, pharmaceutical companies have a financial incentive, particularly those that have vaccines for profit, so we want the decision end of a third dose is taken based solely on public health and not on the economic incentives of the companies ”.
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