For months, pandemic watchers have weighed in on the potential inequity of vaccine distribution, focusing mainly on the First World hoarding supplies that Third World wouldn’t receive. Unexpectedly, it is now Europe that has its boxing gloves on, ready to claw back what it sees as its fair share.
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.
In another move to boost its position in diagnostics for Covid-19 and other infectious diseases, Thermo Fisher Scientific has signed a definitive agreement to acquire privately held molecular diagnostic company Mesa Biotech for $450 million in cash. The business will become part of its Life Sciences Solutions segment.
Members of the European Parliament (EP) at a Jan. 19 plenary debate on the EU’s strategy for Covid-19 vaccine procurement and deployment for the most part expressed support for the common approach to purchasing a common supply for the 27 member states. At the same time, they urged more solidarity in access to inoculation and transparency in contracts with pharmaceutical companies.
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.
Marching to the tune of the groundswell generated by Western Covid-19 vaccines approved, distributed and administered in the US, UK and the EU in recent weeks, Chinese vaccine manufacturers have been beating the drum for their candidates in countries in Latin America and the Middle East as well as at home.
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.
Alexis Pey, Global SHE & Process Safety Manager at Dutch holding Stahl, talks about the company’s safety culture involving the whole organization.
Despite “encouraging” signs of a recovery of chemical production in May from the coronavirus-related “historic slump” in March and April, progress is now slowing, the European Chemical Industry Council (CEFIC) said in its report on the first nine months of 2020.
On Dec. 2, the UK was jubilant about being the first country to issue an Emergency Use Application (EUA) for the Western world’s first coronavirus vaccine, developed by the American-German team of Pfizer and BioNTech. A day later the country was being looked upon as somewhat of a pariah by authorities in the US and EU that saw the move as overly hasty.
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.
US chemistry remains in demand around the world despite ongoing trade tensions and Covid-19. In 2019, the US chemical industry was one of the world’s largest exporters, at $136 billion. The industry has a large and growing trade surplus, reaching more than $35 billion in 2019.
Chinese biotech Sinovac has published data from the Phase 1/2 trial with its Covid-19 vaccine candidate in the journal Lancet Infectious Diseases. The results are said to show that the candidate is capable of inducing a quick antibody response within four weeks of immunization if given in two doses at a 14-day interval.
Sean Diver, president of DCAT speaks about the pharmaceutical industry’s role during the Covid-19 pandemic, trends in drug manufacturing, and key issues for the EU pharmaceutical industry.
Results from the Phase 3 trial of US biotech Moderna’s mRNA-1273 Covid-19 vaccine candidate unveiled on Nov. 15 showed it to be 94.5% effective against the novel coronavirus, with few side effects.
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.
The coronavirus crisis caused by the Covid-19 pandemic has uncovered problems that have been smoldering beneath the surface of the pharmaceutical industry — including CMOs/CDMOs and CROs — and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
NGO Public Citizen has filed a lawsuit against the US Department of Health and Human Services (HHS), seeking to force disclosure of the terms of contracts worth billions of dollar that have been awarded to drugmakers for Covid-19 vaccine development and manufacturing.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.
Johnson & Johnson has temporarily paused all clinical trials of its adenovirus-based vaccine candidates, including the recently begun US Phase 3 trial, due to safety concerns after a study participant suffered an unexplained illness. A two-dose regimen was being tested separately.
Through its subsidiary Janssen Pharmaceutical Companies, US healthcare giant Johnson & Johnson has agreed to provide 200 million doses of its Covid-19 vaccine to the European Union, should the candidate win approval from the US Food and Drug Administration (FDA).
The administration of US president Donald Trump said on Oct. 6 it planned to override the tightening of safety precautions for Covid-19 vaccine proposed by the Food and Drug Administration (FDA) two weeks ago, over fears these could delay approval. Later in the day, it did an unexplained about-turn after the FDA published the guidelines on its own website as part of a briefing for outside vaccine advisers.
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.
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.
