mRNA-based vaccines against the coronavirus have become firmly established in medicine since the pandemic. Nevertheless, the technology is still at the beginning of its potential. Experts see a wide range of potential applications for this relatively new technology, particularly in infectious diseases and cancer.
The European Commission and vaccine makers Pfizer and BioNTech have reached agreement on amending the bloc’s 2021 supply deal for the duo’s Comirnaty mRNA-based shot. The compromise that extends the last planned delivery date to 2026 follows months of discussion, with member states urging the Commission to renegotiate the controversial deal.
German biotech and Covid vaccine maker BioNTech has sealed a major deal with Chinese biotech DualityBio to co-develop and commercialize two cancer antibody drug candidates (ADCs).
Two years after European Commission president Ursula von der Leyen and Pfizer CEO Albert Bourla virtually wrapped up a major order for the Covid-19 vaccine Comirnaty that the US drugmaker markets with Germany’s BioNTech, the New York Times is suing the Commission in the European Court of Justice for its failure to make essential details of the negotiations public.
As it continues to leverage earnings from its top-selling mRNA-based Covid vaccine to deepen its existing knowhow, Mainz, Germany-based BioNtech has announced plans to acquire all of London-based artificial intelligence specialist InstaDeep.
Germany’s BioNTech said it plans to accelerate and broaden the clinical development of its cancer immunotherapy pipeline in the Asia-Pacific region by expanding its clinical footprint to East Asia, specifically Taiwan.
Faced with a lawsuit from US rival Moderna, alleging that Pfizer and its German partner BioNTech infringed one of its patent for their top-selling Covid-19 vaccine Comirnaty, the New York US drugs giant said in a court filing that Comirnaty was based on independent research and wasn’t a Moderna copy.
German Covid-19 vaccine specialist BioNTech has acquired a production facility in Singapore from Swiss drugmaker Novartis that will serve as a manufacturing base in addition to being its Asia-Pacific headquarters.
UK health regulator Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer/BioNTech bivalent Covid-19 vaccine for use as a booster in people 12 years and older.
The newly launched bivalent mRNA-based Covid-19 booster shots from Moderna and Pfizer/BioNTech did not show a major improvement over the companies’ first-generation vaccines targeting the original strain, a small US study conducted by Columbia University and the University of Michigan has found. Detailed data have not yet been released.
The European Public Prosecutors Office (EPPO) has confirmed that it is looking into the EU Commission’s ordering of Covid-19 vaccines, with the probe thought to pertain in particular to order activity outside the usual purchasing channels.
The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and Moderna, combining protection against the original Omicron variant as well as the wild type that emerged in China in early 2020.
As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA vaccine makers Pfizer-BioNTech and Moderna.
BioNTech and Pfizer are facing another lawsuit claiming that their Comirnaty-branded Covid-19 vaccine infringes another company’s patent. The latest to sue is US rival Moderna, which claims the German-American duo copied the original mRNA technology it used for its first-generation shot Spikevax.
Pfizer and BioNTech are fighting back against CureVac’s lawsuit that asserts the makers of the Comirnaty-branded mRNA vaccine for Covid-19 infringed its patent.
Pfizer and BioNTech have filed an application with the European Medicines Agency (EMA) for approval of the Comirnaty Covid-19 vaccine in children aged six months to five years.
Germany’s BioNTech is pushing back against allegations by compatriot CureVac that the company infringed its intellectual property in formulating its mRNA-based Covid-19 vaccine, Comirnaty, that it developed and marketed together with US drugs giant Pfizer.
Sanofi and GSK are touting their latecomer protein-based Covid-19 vaccine as a potential game changer in the fight against the Omicron variant.
In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine Nuaxovid for emergency use. If the health agency agrees, it would be the fourth such shot available in the US, joining the mRNA products of Pfizer/BioNTech and Moderna and the viral vector shot of Johnson & Johnson’s pharma subsidiary Janssen.
Somewhat later than expected, the US may soon be able to offer Covid-19 vaccinations for children five years of age and younger, something parents have repeatedly demanded. And there may be two companies’ mRNA-based shots to choose from.
US health authorities are restricting the use of the Johnson & Johnson Covid vaccine somewhat belatedly, citing the rare blood clotting issues that have dogged this vaccine from the start, as well as the AstraZeneca shot.
An updated version of Moderna’s Covid-19 vaccine is claimed to produce a stronger immune response against major variants of the coronavirus, including omicron and delta, compared to the shot currently administered.
Germany’s economics ministry has budgeted up to €2.9 billion ($3.14 billion) to ensure sufficient supply of mostly mRNA-based Covid-19 vaccines to be able to deal with the ongoing pandemic and any future outbreaks up to 2029.
The US Food and Drug Administration has scheduled a virtual meeting of its scientific advisory panel for Apr. 6 to discuss the prospect of future Covid-19 boosters and the process for updating existing vaccines. The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) will participate.
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose of their Comirnaty vaccine for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
Two German biotechs, RNA vaccines specialist BioNTech and Medigene, a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, have entered a three-year multi-target research collaboration to develop T cell receptor (TCR) based immunotherapies against cancer.
Under order from a US federal judge in Texas, the US Food and Drug Administration (FDA) on Mar. 1 began publishing information relating to Pfizer’s application for approval of the Covid-19 vaccine it developed together with Germany’s BioNTech.
With Covid-19 vaccine distribution in poor countries showing no signs of improvement, Anglo-Swedish drugmaker AstraZeneca and the Covax vaccine sharing program have come fire. The relatively short shelf-life of the pharma group’s viral vector-based shot Vaxzevria in particular is complicating the worldwide rollout, Reuters reports, citing World Health Organization (WHO) documents.
A vaccine to protect children under the age of five against Covid-19 won’t be on the market soon, it seems. Pfizer/BioNtech, the only vaccine maker with near-term plans to launch a children’s vaccine, will not accelerate its application with the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) as some had hoped. Both companies and the health agency now agree that more time is needed.
February kicked off with a major publicity coup for US vaccine maker Novavax, based in the state of Maryland. Its Covid-19 vaccine was granted conditional marketing authorization in the UK, Germany’s vaccine advisory panel recommended its use and the company officially filed with the FDA for emergency use authorization.
Pfizer and BioNTech are poised to begin their first clinical trial with a new vaccine candidate adapted to offer protection against the Omicron variant of the coronavirus. The study with 1,420 healthy adults aged 18 through 55 that will include some of the participants from the companies’ Phase 3 booster study is aimed at determining the potential need for variant-based vaccines.
Up to now, the name BioNTech has popped up mostly in one breath with Pfizer, the company’s US partner in developing the mRNA-based Covid-19 vaccine marketed as Comirnaty. The German biotech, however, is increasingly broadening its horizons. On two consecutive days, Jan. 10 and Jan. 11, the company announced one major new collaboration project and gave an update on a second, both involving British companies.
Pfizer and BioNTech expect to have a modified version of their mRNA-based Covid-19 vaccine ready to tackle the Omicron variant by March, Pfizer CEO Albert Bourla said on Jan. 10. The partners already have begun manufacturing trial doses at their own risk, he said, but did not disclose where they will be sold, only that the doses will be available for countries that need them quickly.
Between the Christmas and the New Year’s bells and on both sides, the international pharmaceutical and healthcare sector continued battling the coronavirus pandemic. In one of the most watched developments – most of which took place in the US – Novavax finally fulfilled its pledge to file final data to the US Food and Drug Administration (FDA) for Emergency Use Authorization of its protein-based Covid-19 vaccine during the year’s fourth quarter.
With the fast rolling wave of yet another Coronavirus variant sparking global concern, vaccine mandates, booster shots and efficacy studies are dominating headlines in the run-up to the year’s end, sidelining chemical companies’ news of progress toward net zero emissions two or three decades down the road. Worries are increasing that millions of people not only have not yet been vaccinated or that some of the vaccines are not protective enough.
