• Friday, 05 July 2024

BioNTech, Pfizer submit application for updated Covid-19 vaccine

BioNTech, Pfizer submit application for updated Covid-19 vaccine
Mainz, Germany, 26 August 2022 (dpa/MIA) — German pharmaceutical company BioNTech and US partner Pfizer have submitted their application for the authorization of their latest Covid-19 vaccine, tailored to the current Omicron variants BA.4 and BA.5, the companies announced on Friday. Half of the new vaccine consists of the same material as their earlier vaccine. The other half is made of a messenger RNA (mRNA) that specifically targets the BA.4 and BA.5 subtypes of the Omicron Covid-19 strain. Data from pre-clinical trials suggests that the updated vaccine provides a "strong neutralizing anti-body response" to these subtypes as well as other types of the Omicron variant. The application also includes information on the quality and production process of the vaccine, and relies partly on data from a study relating to a vaccine tailored to BA.1 that the two companies had submitted for authorization in July. The European Medicines Agency (EMA) recently said that a decision on the applications for BA.1 vaccines by BioNTech and Pfizer, as well as US pharmaceutical company Moderna, are to be reached on September 1. The EMA is already in the process of testing the BA.4 and BA.5 vaccine by BioNTech and Pfizer. The companies already applied for emergency authorization of the same jab in the US on Monday. [caption id="attachment_1463064" align="alignnone" width="1024"] FILED - 21 November 2021, Thuringia, Gera: A medical worker holds a vial of the Moderna vaccine. Photo: Bodo Schackow/dpa-zentralbild/dpa[/caption] Meanwhile, US biotech company Moderna has accused German rival BioNTech — and its partner during the pandemic, pharmaceutical giant Pfizer — of patent infringements in the development of vaccines against the coronavirus. Moderna said on Friday it had filed lawsuits in courts in the United States and Germany. Moderna is seeking compensation for alleged violations of intellectual property rights, but has not yet specified the amount. "We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic," said Moderna chief executive Stéphane Bancel. "We believe that Pfizer and BioNTech unlawfully copied Moderna's inventions, and they have continued to use them without permission," said Moderna chief legal officer Shannon Thyme Klinger, according to a press release. Moderna believes Pfizer and BioNTech copied two key features of Moderna's patented technologies which are critical to the success of mRNA vaccines, according to the press release. Moderna has long been viewed as a trailblazer in efforts to create mRNA vaccines, filing multiple patents between 2010 and 2016, long before the pandemic. Moderna said that it has no desire to see the BioNTech/Pfizer vaccine — marketed as Comirnaty — removed from shelves. And it also noted that it is not claiming patent abuse for any period after March 8, when it agreed it would desist from any patent claims on its vaccines so long as any products were primarily used to provide medical care in a group of 92 low- and medium-income countries. These kinds of patent disputes related to vaccines are not uncommon. Nor are they the first levelled against BioNTech and Pfizer. During the course of a case involving Curevac which started in July, BioNTech said that all of the work of the firm was "original," and that it would defend itself against claims of patent infringement. The rush to get people vaccinated against Covid-19 has been a boon for Moderna, which reported revenue of $4.7 billion in its most recent quarterly statement, for a net profit of $2.2 billion. This year, Moderna anticipates income of $21 billion thanks to its vaccines division. However, Moderna invests large parts of its income back into research. Pfizer and BioNTech have also profited handsomely from Comirnaty.