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.
The more things change, the more they stay the same, at least in pandemic times, in Europe. After its second look at an unusual string of rare blood clotting incidents, mostly in younger women receiving AstraZeneca's Covid-19 vaccine, the European Medicines Agency (EMA), the EU’s drugs regulator, said on Apr. 7 it believes there is probably a “strong association” but stressed once again that the benefits of vaccination outweigh any risks.
Germany’s BioNTech and US drugmaker Pfizer have again corrected upward the 2021 production forecast for their Covid-19 vaccine marketed as Comirnaty. The partners now say they will manufacture an additional 500 million doses this year, lifting the output target to 2.5 billion doses. After last year’s pledge to produce 1.3 billion doses this year, in January they raised the target to 2 billion.
As one glitch after another at Covid vaccine suppliers upends deliveries, the German federal government is drawing up plans to build up production within its borders, federal health minister Jens Spahn said at a weekly news conference, thereby confirming remarks made by future vaccine commissioner Christoph Krupp in a pre-published newspaper interview.
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.
BioNTech this week kicked off production at the Marburg, Germany, plant it acquired last year from Novartis. The plant will focus on making mRNA batches, the beginning of the manufacturing chain for the Covid-19 vaccine Comirnaty that BioNTech is producing and marketing together with US drugmaker Pfizer.
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.
Expanding its supply relationship with compatriot BioNTech, Germany’s Merck said it will “significantly accelerate” the supply of urgently needed lipids to vaccine maker BionTech at Mainz and increase the volume of deliveries up to the end of 2021.
Following initial euphoria over conditional marketing approval of two Covid-19 vaccines by the European Medicines Agency (EMA) in recent weeks, EU countries are turning sour on the first-past-the-post team, as Pfizer and BioNTec have informed authorities of what in a worst case scenario could be a massive shortfall in near-term deliveries.
US drugmaker Pfizer and partner BioNTech have confirmed they will temporarily reduce Covid deliveries to Europe as Pfizer revamps its designated plant in Belgium to lift production capacity to 2 billion doses per year, as announced earlier.
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.
Germany-based BioNTech and its Chinese partner Shanghai Fosun Pharmaceutical have agreed to provide an initial 100 million doses of the Mainz-headquartered company’s mRNA-based Covid-19 vaccine candidate to the People’s Republic of China in 2021, subject to regulatory approval. Initial supply will be from BioNTech’s production facilities in Germany.
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.
In a move that was not on the world’s radar, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has become the first Western regulatory body to issue an Emergency Use Authorization EUA) for a Covid-19 vaccine, Pfizer-BioNTech’s BNT162b2 candidate.
As planned, US drugmaker Pfizer and German biotech BioNTech filed an Emergency Use Authorization (EUA) request with the US Food and Drug Administration (FDA) for their mRNA-based Covid-19 vaccine candidate BNT162b2 on Nov. 20.
US drugmaker Pfizer and its German development partner BioNTech have reached a final agreement with the European Commission to supply 200 million doses of their mRNA-based Covid19 vaccine candidate to the EU’s member states at an undisclosed price.
Phase 3 clinical trials with the mRNA vaccine candidate BNT162b2 being developed by US pharma giant Pfizer and German biotech partner BioNTech have shown it to be more than 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced in a preliminary look at efficacy.
German CDMO Rentschler Biopharma has reached agreement with Pfizer and BioNTech to handle the downstream purification process for the partnership’s mRNA-based COVID-19 vaccine. No price tag was disclosed for the deal that also calls for the CDMO to handle small-batch manufacturing for a range of BioNTech's other mRNA clinical-stage projects.
Only a few weeks ago, the race to bring Covid-19 vaccines was in high gear. Now some think the pace should be slower, amid AstraZeneca’s much commentated adverse event during its UK Phase 3 trial and US president Donald Trump’s haste to have a vaccine ready for deployment before the Nov.3 US elections.
German biotech BioNTech has signed a share purchase agreement with Novartis to acquire the Swiss drugmaker’s GMP-certified manufacturing facility in Marburg, Germany. The deal will expand the Mainz-based company’s Covid-19 vaccine production capability by up to 750 million doses per year, or over 60 million doses per month, when fully operational.
The Covid-19 initiative of the German Federal Ministry of Education and Research (BMBF) has awarded a milestone-based grant of up to €375 million for BioNTech, the Mainz, Germany-based biotech, to support its efforts to develop a commercially available vaccine against the virus.
With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.
The Covid-19 vaccine partnership of Germany’s BioNTech and US drugs giant Pfizer inked its third supply pact in a week on Jul. 31. This deal, with the Japanese Ministry of Health, Labor and Welfare (MHLW), follows separate agreements with the US and UK signed in the two preceding days.
European officials recently began talking to companies developing Covid-19 vaccines about supplying the EU’s 27 member states, in hope that none would fall behind bigger markets such as the US, which began making exclusive deals early on. Now Reuters suggests the talks may have hit a snag.
The world’s governments are signing vaccine supply pacts fast and furiously now, as the world continues to hope an effective prevention against Covid-19 will be found soon. Days after signing on with the UK government, German biotech BioNTech – working with American drugs giant Pfizer – has inked a deal with the US and is reportedly also talking to the EU.
The UK has signed an agreement to secure 90 million doses of Covid-19 vaccines developed by Germany’s BioNTech and France’s Valneva. The deals, for which financial terms were not disclosed, foresee taking 30 million doses from the German and 60 million from the French company.
Germany’s BioNTech is confident it will be ready to seek regulatory approval for its mRNA-based Covid-19 vaccine by the end of this year, its co-founder and chief executive Ugur Sahin said in an interview with the Wall Street Journal (WSJ).
German biotech BioNTech, which is working on developing an mRNA vaccine against Covid-19 and has aligned itself with US pharma major Pfizer, this week raised $250 million (€223 million) in an offering that attracted Singapore state-owned private equity investor Temasek and other unnamed accredited investors.
To save manufacturing space for its growing vaccines plans, Pfizer has said it will outsource production of some of its pharmaceutical portfolio. The work is planned to be shared out with a network of 200 contractors in the US and Europe.
Paul-Ehrlich-Institut (PEI), Germany’s federal institute for vaccines and biomedicines, has given the go-ahead for Germany’s first clinical trial of a vaccine candidate to prevent COVID-19.
