Novartis and market watchers alike have been dropping repeated hits that a sale of the Swiss drugs giant’s Sandoz-branded generic drugs arm may be closer than has been hinted up to now. In an interview with German weekly news magazine Wirtschaftswoche last week, CEO Vas Narasimhan said, however, that beyond several requests for information no concrete offers are currently on the table.
As the most recently documented Covid-19 variant, Omicron, continues to rapidly circle the globe – it has now been found in 57 countries and 21 US states, according to the US Centers for Disease Control – Pfizer and BioNTech have become the first vaccine manufacturers to claim that their booster shot can deal with it.
In response to new data published by rival Merck that downgrade earlier efficacy forecasts for its for Covid-19 oral antiviral treatment, Pfizer has announced will increase production capacity of its own antiviral pill Paxlovid as it waits for an emergency use authorization (EUA) from the FDA.
Days before news of the omicron-dubbed latest coronavirus mutant emerged, the administration of US president Joe Biden called on the courts to remove a stay on the implementation of its plans to mandate Covid-19 vaccines mandatory for employees of all companies employing more than 100 people by Jan. 4, 2022 or require them to undergo weekly testing.
The delta variant of the coronavirus is taking its toll on Europe as vaccine skepticism shows no signs of going into remission, and promising oral treatments developed by Pfizer and Merck & Co have not yet been approved. With deaths now feared to top 2 million by March 2022, the World Health Organization (WHO) says the pandemic has become the leading cause of death in the region, whereby it helps to know that the WHO’s definition includes such countries as Russia, Ukraine, Tajikistan and Israel.
Pfizer and BioNTech are expected to seek an Emergency Use Authorization (EUA) for their Covid-19-vaccine booster shot to be given to anyone 18 and older, an unnamed US official told journalists on Nov. 8, confirming a report by the newspaper Washington Post. The request could be made as early as this week, reports said.
Novavax has completed the submission of real time data to the UK’s Medicines and Health Regulatory Authority for the authorization of its Covid-19 vaccine candidate. It would be the first protein-based shot to be approved by the British drugs regulator.
Özlem Türeci and Uğur Şahin, founders and managing board members of Mainz-based BioNTech, were inducted into the Hall of Fame of German Research (Hall of Fame der deutschen Forschung) on Oct. 21. The awards ceremony in Wiesbaden, Germany, was organized by German pharmaceuticals, chemicals and life sciences group Merck together with Manager Magazin.
In a decision not everyone anticipated, the EU’s drugs regulator, European Medicines Agency, EMA, announced on Oct. 4 it was authorizing a booster shot of the Pfizer/BioNTech and Moderna Covid-19 vaccines for healthy adults, to be given at least six months after the second dose.
Acting quickly after its advisory panel published its guidance, the US Food and Drug Administration (FDA) on Sept. 22 announced it was amending its Emergency Use Authorization (EUA) for Pfizer/BioNTech’s Covid-19 vaccine to allow a booster dose to be administered at least six months after completion of the primary series.
The US plans to more than double its commitment to donate Covid-19 vaccines to the developing world, President Joe Biden announced on Sept. 22 at a virtual vaccine summit he organized on the sidelines of the United Nations September general assembly.
Phase 2/3 clinical trials with the Pfizer/BioNTech Covid-19 vaccine Comirnaty have shown that it is safe, well tolerated and produces robust neutralizing antibody responses in children aged 5 to 11 years, the companies said on Sept. 20. The vaccine partners now plan to submit the data to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies around the world “as soon as possible.”
Two key vaccine officials of the US Food and Drug Administration (FDA) plan to quit the agency over the next three months in protest against President Joe Biden’s plan to offer Covid-19 booster shots to all Americans starting this month, even if they only received their second shot five months earlier.
Pfizer and BioNTech, partners in developing, producing and marketing the Covid-19 vaccine now called Comirnaty, have sealed a deal with CDMO Eurofarma Laboratories of Brazil to produce the vaccine for distribution in Latin America.
US biotech Moderna announced on Aug. 26 that it had completed its filing with the US Food and Drug Administration (FDA) for full marketing approval of its mRNA-based Covid-19 vaccine for people age 18 and older. The company said it has requested a priority review as was granted the Pfizer-BioNTech shot, also mRNA based.
First to receive US approval under an Emergency Use Authorization (EUA) in late 2020, the BioNTech/Pfizer Covid-19 vaccine on Aug. 23 became the first to be fully approved by the US Food and Drug Administration (FDA) for marketing and use in the country.
As the delta variant of the coronavirus tears through the US, pushing both new and breakthrough infections higher, the US Centers for Disease Control (CDC) has now come out in favor of recommending that vulnerable individuals be given booster shots.
Pfizer and BioNTech applied to the US Food and Drug Administration (FDA) in May for full authorization of their Covid-19 vaccine Comirnaty, and in the interest of encouraging more Americans to get vaccinated the health agency is now conducting a priority review to speed the approval process.
BioNTech has launched a new project aimed at developing what it hopes will be a well-tolerated and highly effective malaria vaccine for the African continent. The Mainz, Germany-based company, which developed a Covid-19 vaccine together with Pfizer in only ten months, said its goal is to produce the malaria vaccine locally.
As part of a new supply chain partnership, South Africa’s Biovac will produce Pfizer and BioNTech’s Comirnaty-branded Covid-19 vaccine at its Capetown site from the end of 2021, the companies announced this week.
Germany’s BioNTech, best known publicly for the Covid-19 vaccine Comirnaty it developed in partnership with US drugs giant Pfizer, has announced plans to buy a cell therapy R&D platform and clinical manufacturing plant from Gilead Sciences’ Kite Pharma subsidiary.
The prospects for Johnson & Johnson’s viral vector vaccine to play a major role in the global inoculation against Covid-19 in the developed world are looking increasingly dim. The latest blow is that the US Food and Drug Administration (FDA) is preparing to mandate a warning label that the vaccine can lead to an increased risk of Guillain–Barré syndrome, a rare but serious neurological condition.
Pharma giant Pfizer plans to ask the US Food and Drug Administration (FDA) to authorize a booster dose of the Covid-19 vaccine it makes with Germany’s BioNTech. The company said it will file an application within the next month.
The US Food and Drug Administration (FDA) added information about myocarditis and pericarditis to its fact sheets for the mRNA-based Moderna and Pfizer/BioNTech Covid-19 vaccines on Jun. 25.
The European Commission’s attempt to hold AstraZeneca (AZ) responsible for the delayed and truncated supply of its Covid-19 vaccine appears to have not produced the desired result, at least not in the first lawsuit to be heard.
AGC Biologics has agreed to supply plasmid DNA (pDNA) to Pfizer/BioNTech for their RNA-based Covid-19 vaccine. The biopharma CDMO based in Heidelberg, Germany, will manufacture the vaccine ingredient at its Heidelberg facility.
As expected, US president Joe Biden, on his first international trip since taking office in January, announced plans to donate 500 million doses of the Pfize/BioNTech Covid-19 vaccine to around 100 countries over the next year. The plans were leaked by the newspaper Washington Post hours before the president’s departure with First Lady Jill Biden for the G7 summit in the UK.
As the G20’s first global health summit convened virtually in Rome, Italy, on May 21, the leaders of 19 countries and the EU called for greater global cooperation to end the coronavirus crisis. Major Covid-19 vaccine manufacturers including Pfizer/BioNTech, Moderna and Johnson & Johnson pledged to make a total of 2.3 billion doses available to poor countries over the next 2 years. The commitments call for 1.3 billion doses to be delivered in 2021 and 1 billion in 2022.
US president Joe Biden announced this week that his administration will send an additional 20 million Covid-19 vaccine doses abroad by the end of June, this time including some approved for use in the US.
Pfizer and BioNTech have applied to the US Food and Drug Administration (FDA) for full approval of their Covid-19 vaccine in adolescents aged 12 to 15. If successful, the American-German duo’s shot now called Comirnaty would be the first in the US to obtain this status. It also was the first to win an emergency use authorization (EUA), in December 2020
The long simmering discussion over whether manufacturers of Covid-19 vaccines should waive their intellectual property (IP) rights in hope of giving more people access to a shot and whether this would indeed end the pandemic faster reached the boiling point on May 5 when the US unexpectedly joined a group of developing nations pushing for such a move.
The EU has clinched the deal with vaccine team Pfizer/BioNtech hinted at in mid-April. European Commmission president Ursula von der Leyen late last week informed member states about the agreement that foresees delivery of 1.8 billion additional doses of the duo’s mRNA-based Covid-19 vaccine though 2023. This includes an initial 900 million doses with an option for another 900 million.
The European Commission has confirmed rumors that it has initiated legal action against AstraZeneca for failing to meet contractual obligations for deliveries of Its Covid-19 vaccine. Health commissioner Stella Kyriakides said the action is being taken jointly with all 27 member states.
German specialty chemicals producer Evonik delivered the first batches of lipids for BioNTech’s mRNA-based Covid-19 vaccine on Apr. 22, months earlier than planned. Deliveries were expected to start in mid-2021 but the company said it was able to set up production in just eight weeks at its complex in Hanau, Germany, and meet the high-quality requirements for the component.
The Italian government has held talks with several pharmaceutical companies, including Moderna, Novartis, CureVac and Italy’s ReiThera, about producing mRNA-based Covid-19 vaccines in the country, the Financial Times (FT) has reported, citing people familiar with the matter.
