Definitive results from CureVac’s 40,000-subject international Phase 2b/3 trial with its mRNA-based Covid-19 vaccine candidate, CVnCoV, have confirmed an earlier finding that it is only about 48% effective in preventing infection of any severity across the “unprecedented” 15 strains of the virus encountered during the tests with participants in Latin America and Europe.
South Korea-based CDMO SK Bioscience, with cash in hand from an initial public offering, has announced plans to pour 150 billion won ($132 million) into vaccine production up to 2024, which will mean to adding some 99,130 m2 of production space and equipping its plant at Andong to make newer mRNA- and viral vector-based Covid-19 vaccines.
In conjunction with its American Rescue Plan, the administration of US president Joe Biden has announced its intention to spend $3 billion on building a stockpile of pharmaceuticals that can be used to treat Covid-19 and other viral threats of the future.
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.
In a stunning setback to the company’s ambitions of launching its mRNA-based Covid-19 vaccine in the third quarter, results from CureVac’s Phase 2b/3 trial showed the candidate branded CVnCoV to have an efficacy rate of only 47% against any severity of the disease.
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.
The US Supreme Court has declined to hear Johnson & Johnson’ appeal against a $2 billion judgment in favor of 22 ovarian cancer sufferers who claimed they contracted the cancer from using the healthcare group’s talc products.
India’s Bharat Biotech, which specializes in infectious diseases, has announced it is adding new manufacturing capacity for its Covid-19 shot known as Covaxin, India’s first indigenous vaccine. The expansion will go on stream in this year’s fourth quarter at the Ankleshwar site operated by wholly owned subsidiary Chiron Behring Vaccines.
In 2020, the weakness associated with global chemical supply chains was highlighted in a dramatic manner as Covid-19 was designated a global pandemic. As a result, small modular continuous flow plants are gaining attention as an appropriate solution to secure supply chains whilst ensuring safe, sustainable processes are implemented.
The G 20 global health summit to be held in Rome, Italy, on May 21 is expected to commit to fund the distribution of Covid-19 vaccines and drugs to poorer countries, in an effort to make prevention and treatment of the coronavirus accessible for poorer nations. Press reports said, however, the original language of the commitment had been watered down from a more ambitious plan to commit to “fair and full financing.”
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
Swiss CDMO Lonza and US vaccine maker Moderna have extended and deepened their collaboration on the US biotech’s mRNA- based Covid-19 shot. The new agreement, which calls for the installation of three new production lines and a doubling of existing drug substance production at Lonza’s Visp, Switzerland, site, builds on a 10-year pact signed last year.
As India’s Covid-19 infections soar and the death toll nears 200,000, wealthier countries – including the US, UK, Germany, France and Australia – are rushing supplies of oxygen, ventilators and protective gear to the subcontinent.
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 CPhI executive post-pandemic pharma survey, produced by Informa Markets as part of the CPhI Pharma 2021 Report, predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next 5 years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.
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.
Recent studies show that contract manufacturers for the pharmaceutical industry, so-called CDMOs (contract development and manufacturing organizations), have so far been little involved in the production of vaccines. This is changing with the outbreak of the Covid-19 pandemic.
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.
The European Parliament (EP) has adopted the EU4Health program for 2021-2027 put forward by the European Commission in May 2020 as a response to the Covid-19 crisis. The plenary vote earlier this month confirmed a provisional agreement with the European Council aimed at preparing the EU’s health systems for future health threats and pandemics.
The AstraZeneca Covid vaccine’s brief respite from global negative headlines achieved after it published positive results from its US clinical trial on Mar. 22 was even briefer than usual. Soon after publication, the figures were criticized by the trial’s independent data safety monitoring board (DSMB), a move experts called unprecedented or at least highly unusual. The drugmaker promised to publish more information within 48 hours.
After a day’s deliberation, the European Medicines Agency (EMA) has decided that AstraZeneca’s Covid-19 vaccine is safe and effective and that potential side effects observed across the EU are not too great to run the risk of being infected with the virus.
As the world awaited conclusive words from the European Medicines Agency (EMA) on the safety of the AstraZeneca Covid-19 shot, the vaccine war between the UK and the EU appeared to be intensifying. With manufacturers struggling to meet supply commitments, both sides see their inoculation programs at risk.
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.
AstraZeneca’s Covid vaccine is drawing negative headlines again after several incidences of blood clots have been reported, including the death of a 49-year-old nurse from multiple thrombosis 10 days after receiving the shot. On Mar. 10, eight countries had suspended injections from a batch labeled ABV5300 or halted use of this vaccine pending clarification.
The EU cleared Johnson & Johnson’s Covid-19 vaccine for conditional marketing in all 27member states on Mar. 11 as expected. The single-dose adenovirus shot made by subsidiary Janssen Biotech, under a rolling review since December 2020, is the fourth to be approved by the European Medicines Agency (EMA).
The Russian government has clinched a deal to produce its Sputnik V Covid-19 vaccine in Italy and will proceed with the project even if the European Medicines Agency (EMA) decides not to approve the candidate, the Italian-Russian Chamber of Commerce said. “The innovative production process will help create new jobs and allow Italy to control the entire production of the compound,” it added.
As immunization woes mount, France has done a stunning about-turn and modified age limits it had placed on the AstraZeneca/Oxford vaccine. Germany may be on the brink of following suit, while Spain and Italy have not yet hinted at any moves in that direction. Earlier, French president Emmanuel Macron had labeled the UK-developed vaccine “quasi ineffective” but now says he would get it himself.
For mRNA vaccine maker Moderna, March is gearing up to roar in like a lion, with the tailwind setting the pace for the year ahead. Reporting 2020 financial results on Feb. 25, the US biotech that before last year had not sold a single product said it expects to take in more than $18 billion in revenue from sales of Covid-19 vaccines during 2021.
On the same day that Sanofi and GSK announced the start of a new Phase 2 study of their delayed adjuvanted recombinant protein-based Covid-19 vaccine candidate, Sanofi disclosed it had signed an agreement to manufacture 12 million doses of Johnson & Johnson’s single-dose adenovirus-based Covid vaccine.
For the report "Value Creation in Chemicals 2020: Bouncing Back from a Year of Adversity", Boston Consulting Group (BCG) analyzed the development of the global chemicals market in the Covid-19 crisis in 2020 and in the years 2015 to 2019 using key figures. The result shows: The current crisis is forcing companies to increase their resilience. The entire value chain, exposure to the end industry, and technical, commercial and digital capabilities must be put to the test in order to respond more effectively to changes in the markets in the future.
New US president Joe Biden has pledged to release altogether $4 billion in US funding to support Gavi, the global vaccine alliance. The president was expected to announce an initial $2 billion in funding at the virtual G-7 summit of the world’s largest economies on Feb. 19.
As had been awaited, US healthcare giant Johnson & Johnson has applied to the European Medicines Authority (EMA) for conditional marketing authorization of its Covid-19 coronavirus vaccine throughout the EU.
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.
Johnson & Johnson's Covid-19 vaccine just emerging from Phase 3 clinical trials showed 66% efficacy in moderate to severe disease, and as much as to 85% in severe disease, the US healthcare group said in its first report on trial results.
Vaccines and treatments for Covid-19 continue to dominate global pharma market headlines. As the pandemic drags on, new issues continuously arise, some of them discouraging, such as the emergence of more and more virus mutants or production glitches that threaten to curb supply.
