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.
Astra Zeneca’s relationship with the EU is at rock bottom. Within three days, news emerged of deaths from blood clots in people receiving the UK drugmaker’s vaccine, and drugs regulator European Medicines Agency (EMA) said it was studying reports that 41 people receiving the shot in the UK had suffered an anaphylaxis reaction. What’s more, the company just took back another supply commitment.
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.
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.
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.
The World Health Organization (WHO) has granted emergency use authorization (EUA) to the AstraZeneca/ Oxford University coronavirus vaccine, in an attempt to distribute doses to more Third World countries. The vaccine will be produced by the Serum Institute of India and AstraZeneca-SKBio of South Korea.
As expected, the Europe Medicines Agency (EMA) on Jan. 29 gave the green light for AstraZeneca’s Covid-19 vaccine for use in the Covid-19 vaccine for use in the 27-member EU. Rather than this news, however, the political fallout over the bloc’s response to the drugmaker’s delivery delays announced at the beginning of the week continued to dominate the conversation.
AstraZeneca’s viral vector vaccine candidate for Covid-19, AZD1222, moved back into the spotlight again this week after giving up headlines recently to the mRNA candidates of Pfizer-BioNTech and Moderna.
AstraZeneca’s paused Phase 3 US clinical trial with its Covid-19 adenovirus vaccine candidate could resume as early as this week, sources have told both Reuters and the Wall Street Journal. The drugmaker initially paused all global trials in early September, after a participant in the UK Phase 3 test suffered a spinal inflammatory disorder. The purported diagnosis of transverse myelitis was never officially confirmed.
Korean CMO Samsung Biologics has signed on with AstraZeneca to support the UK drugmaker’s biologics therapeutics. The company will produce bulk drug substance and drug product for its customer at its new $2 billion Plant 3 facility in Incheon, South Korea, set to go on stream in 2022.
The US Food and Drug Administration (FDA) is deliberating whether to allow AstraZeneca to resume its recently begun Phase 3 US clinical trial of the adenovirus-based Covid-19 vaccine it is developing for Oxford University. An adverse event last week caused the – meanwhile resumed – UK study to be paused,
AstraZeneca has resumed Phase 2/3 clinical trials with Oxford University’s Covid-19 vaccine candidate in the UK, days after halting the tests due to an “adverse neurological event” that CEO Pascal Soriot said occurred in the UK trial and involved an inflammatory spinal cord disorder.
AstraZeneca has temporarily paused Phase 2/3 global clinical trials of the adenovirus-viral vector-based Covid-19 candidate it is developing for Oxford University. The Anglo-Swedish drugmaker initially cited “a serious suspected adverse reaction” in a participant without revealing details.
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.
After months of uncertainty and anxious glances across the water as potential Covid-19 vaccine manufacturers made deal after deal with other political blocs, the EU over the past four weeks has made rapid strides toward securing supplies for its 27 member states.
Catalent Cell & Gene Therapy, a unit of US-based CDMO Catalent, has signed on to provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, known as AZD1222. Financial details were not disclosed.
The government of Australia has sealed a deal with AstraZeneca to supply enough doses of the adenovirus vector-based vaccine being developed on behalf of Oxford University to inoculate 95% of the country’s entire population of 25 million. The two sides have signed a Letter of Intentm but details on how the ambitious vaccination plan would be financed have not been revealed.
In a much heeded licensing deal, AstraZeneca (AZ) has awarded Chinese pharma BioKangta sole commercial rights to its AZD1222 Covid-19 vaccine candidate in the People’s Republic. The UK drugmaker is developing the adenovirus vector-based vaccine on behalf of Oxford University, which created it.
UK-Swedish drugmaker AstraZeneca has entered into a global development and commercialization agreement with Daiichi Sankyo, which could be worth up to $6 billion for the Japanese pharma.
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.
