The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and Moderna, combining protection against the original Omicron variant as well as the wild type that emerged in China in early 2020.
Days before the FDA approved the new bivalent Covid-19 vaccine boosters, Pascal Soriot, CEO of AstraZeneca, offered his own assessment of the need for such.
As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA vaccine makers Pfizer-BioNTech and Moderna.
BioNTech and Pfizer are facing another lawsuit claiming that their Comirnaty-branded Covid-19 vaccine infringes another company’s patent. The latest to sue is US rival Moderna, which claims the German-American duo copied the original mRNA technology it used for its first-generation shot Spikevax.
To meet surging global demand for its Jynneos-branded monkeypox vaccine, Danish biotech Bavarian Nordic (BN) is pulling out all stops. Strategies include outsourcing production of other vaccines to CDMOs and exploring the reuse of millions of doses that have technically expired but are still viable.
CureVac and GSK have announced they are launching a Phase 1 clinical trial with their modified mRNA-based Covid 19 vaccine CV051, which would be recommended as a booster to protect against the omicron variant.
It took longer than expected, but the US Food and Drug Administration (FDA) on July 13 finally granted an Emergency Authorization (EUA) to Nuaxovid, the protein-based sCovid-19 shot developed by Novavax.
The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have ordered 3.2 million doses of Novavax’s Covid-19 vaccine, even before the protein-based and adjuvanted shot has cleared the US Food and Drug Administration.
UK specialty chemical company Croda International will receive up to $75 million from the US government to expand its US capacity to produce ingredients for lipid systems used in novel therapeutic drugs, such as mRNA vaccines.
Sanofi and GSK are touting their latecomer protein-based Covid-19 vaccine as a potential game changer in the fight against the Omicron variant.
Pfizer is to invest $95 million and take an equity share of 8.1% in in Valneva in order to further support development of a vaccine for Lyme disease.
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.
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.
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.
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.
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.
US biotech Novavax has again delayed filing for approval of its protein-based Covid-19 vaccine at least until July this year, citing issues related to an assay needed to show that its manufacturing process is consistent across different sites. CEO Stanley Erck said the company now aims to submit data to regulators in the UK, US and EU in the third quarter of 2021 rather than in the second quarter as previously planned. The vaccine is currently in a rolling review with the European Medicines Agency (EMA).
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
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 rollout of Johnson & Johnson’s Covid-19 vaccine could be resumed starting Apr. 23, Anthony Fauci, the top US infectious-disease expert and chief advisor to US president Joe Biden on pandemic-related issues, has told US media.
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.
Denmark has taken what it said was a final decision to discontinue using the AstraZeneca Covid-19 vaccine in its national inoculation campaign after an unusual string of rare blood clots. A discussion has begun over what to do with the remaining supply.
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.
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.
