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.
For its annual report "Value Creation in Chemicals 2021 – Ten Years of Steady Growth – and a Few Superstars," the strategy consultancy Boston Consulting Group examined the performance of leading international chemical companies from 2011 to 2020. The long-term perspective shows that the industry has mastered serious market downturns with astonishing confidence.
The Covid-19 vaccine Covifenz made by Canada’s Medicago, approved for use in the country in February, has been rejected for review by the World Health Organization (WHO) on grounds that the company is partly owned by tobacco company Philip Morris.
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.
Health Canada has approved the recombinant Covid-19 vaccine produced by Canadian biotech Medicago that uses the pandemic adjuvant made by British pharma giant GlaxoSmithKline. The shot marketed as Covifenz uses a plant-based virus-like particles technology to imitate the coronavirus’ spike protein.
After several delays, Sanofi and GlaxoSmithKline are preparing to submit data to regulatory authorities to support approval of their adjuvanted protein vaccine against Covid-19.
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.
As wealthy countries with ample supplies of Covid-19 vaccine struggle to convince more people to get the shot, and poorer countries struggle to nail down supplies, two US vaccine makers are making negative headlines. While EU and UK approval of the Novavax vaccine was just celebrated with fanfare, that company as well as Johnson & Johnson is now said to face delivery delays.
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.
In a 6:3 vote, the US Supreme Court has temporarily blocked the Biden administration from implementing its executive order requiring companies with more than 100 employees to have their staff vaccinated against Covid-19 or tested weekly. At the same time, it voted 5:4 to let stand the order requiring that all of the more than 10 million healthcare workers be vaccinated.
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.
US biotech Amyris has formed a 50:50 joint venture with compatriot clinical-stage immunotherapy firm ImmunityBio to accelerate the commercialization of a next-generation Covid-19 vaccine. The companies signed a binding agreement for the venture last November.
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.
The Life Science business segment of Germany’s Merck has won a €121 million US government contract to build a new plant for its “Hi-Flow" Plus lateral flow membranes used in rapid diagnostic test kits, including those for Covid-19.
US Army scientists working at the Walter Reed Army Institute of Research attached to the US military medical center of the same name have hinted at promising results from early stage clinical trials with a newly developed vaccine they believe could be capable of targeting all coronaviruses, including mutations of the virus currently causing Covid-19.
Following a recommendation by the European Medicines Agency (EMA), the European Commission has granted conditional marketing authorization to the protein-based Covid-19 vaccine made by US biotech Novavax. It is the fifth shot to be made available in all 27 member states and the first protein-based.
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.
The US Senate has narrowly voted, 48 to 52, in favor of a Republican Party resolution to block president Joe Biden’s Covid-19 vaccine mandate for companies employing 100 people or more. Two conservative senators from Biden’s Democratic Party voted with the opposition.
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.
Fujifilm Diosynth Biotechnologies is investing £400 million to expand its Teesside site in northeast England, where it makes the active ingredient for the Novavax Covid-19 vaccine. The Japanese company said the expanded facilities are set to open in 2023 or early 2024, creating as many as 350 “highly skilled jobs” in contract manufacturing.
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.
The UK has “pipped the US at the post”, as one commentator noted in typical British colloquialism on the news that the country’s health regulator MHRA has approved the Covid-19 antiviral pill molnupiravir developed by US Merck & Co together with US biotech Ridgeback Biotherapeutics.
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.
Diverse developments taking place simultaneously in Covid-19 vaccines and treatments, especially in the US, are making it difficult for the average market watcher – and anti-vaccine enthusiasts – to keep up. While the past ten days have seen some concrete progress on boosters, following weeks of discussion, uncertainty lingers on some topics.
AstraZeneca has provided the US Food and Drug Administration (FDA) with encouraging study evidence that its antiviral cocktail candidate AZD7442 can prevent Covid-19 infections in vulnerable people, such as those who are unlikely to respond well to vaccines. This followed disappointing results from an earlier study.
A year ago unthinkable, the market for mRNA-based Covid-19 vaccines appears to be headed for saturation, even though, or perhaps because, there now seem to be more products on the market than first-world consumers want or need.
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.”
German biotech CureVac has canceled manufacturing contracts with two prospective partners for its Covid-19 vaccine CVnCoV while retaining others. The company said on Sept. 14 it would end the arrangements with Germany’s Wacker Chemie and Switzerland’s Celonic Group, but leave the deals with Rentschler Biopharma and Novartis intact.
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.
As it continues to grapple with documentation issues, US biotech Novavax has again altered its timeline for seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its two-dose Covid-19 vaccine. Concurrently, the US government is curbing some of the funding awarded last year by the administration of former president Donald Trump.
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.
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.
