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.”
Digital tools are a key to shortening the development of active pharmaceutical ingredients and thus market-ready drugs and therapies.
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.
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 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.
The (almost) worst-case scenario in the mix-up of Johnson & Johnson and AstraZeneca’s Covid-19 vaccine at the Baltimore, Maryland, plant of CDMO Emergent BioSolutions apparently has occurred. After an extensive FDA probe at the site, it was determined that around 60 million J&J doses will have to be discarded, the newspaper New York Times reported.
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.
US pharma giant Pfizer has acquired privately owned Amplyx Pharmaceuticals for an undisclosed sum. With the purchase of the clinical-stage biopharmaceutical company based at San Diego, California, the New York drugmaker will expand its anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001).
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.
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.
The European Commission has decided against renewing its Covid-19 vaccine supply contracts with AstraZeneca and Johnson & Johnson when they expire at the end of the current year, Italian newspaper La Stampa has reported, citing an unnamed source from the Italian health ministry.
China’s WuXI Biologics has agreed to buy Pfizer’s biologics manufacturing facilities in Hangzhou for an undisclosed price. The transaction is expected to close in the first half of 2021. The Shanghai-based company said the acquisition will immediately boost its capacities for commercial drug substance (DS) and drug product (DP) capacities to address surging manufacturing demand.
Trying to stay ahead of both coronavirus developments and criticism that it is moving too slowly or in the wrong direction, Europe is piling on fresh orders for the BioNTech-Pfizer vaccine. On Mar. 10, it announced it had agreed to acquire 4 million additional doses for delivery in the next two weeks.
With the race to vaccinate populations against Covid-19 going full steam, health agencies such as the World Health Organization (WHO) and the Serum Institute of India (SIL), world’s largest vaccine maker, have raised alarm that nationalism and protectionism could lead to an international vaccine trade war that in particular could disadvantage countries with insufficient resources.
For several days, the Pfizer-BioNTech Covid-19 vaccine Comirnaty (BNT162b2) has dominated international headlines. From the market’s perspective, the most significant news is that the partners, as hinted earlier, have been able to reformulate the doses to facilitate storage at a higher temperature.
Pfizer and BioNTech are accelerating the time it takes to produce a Covid-19 vaccine batch and are aiming to almost cut it in half, Chaz Calitri, vice president of sterile injectables at Pfizer, said in an interview with the US newspaper USA Today.
Germany’s BioNTech has scaled up its projections for the number of doses of its Covid-19 vaccine it will make this year from 1.3 billion to 2 billion, as it seeks approvals from regulatory agencies outside the US, UK and the EU, where its Comirnaty-branded product is already on the market.
Unsurprisingly in view of the surging cases of Covid-19 worldwide, there was little interruption in the flow of vaccine news – or at least talk about vaccines– during the Christmas and New Year break.
The European Medicines Agency (EMA) on Dec. 21 provisionally cleared EU-wide use of the Pfizer-BioNTech Covid-19 vaccine, which will be marketed under the brand name Comirnaty. The Conditional Marketing Authorization paves the way for a rollout across the 27 member states, which is slated to begin by the end of the month and is expected to be a major logistics challenge.
Facing scrutiny from the manufacturers, health ministers of some member states and the public, the European Medicines Agency (EMA) has moved the timetable to conclude data analysis of the Pfizer-BioNTech Covid-19 vaccine candidate BNT162b2 forward by a week.
The US Food and Drug Administration on Dec. 11 awarded an emergency use authorization (EUA) for the Pfizer-BioNTech mRNA-based Covid-19 vaccine. The green light followed a recommendation hours earlier by the US health regulator’s advisory panel, which voted 17 to 4 in favor – with one abstention – to offer the shot to people 16 years of age and older.
