AZD1222

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab

South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been …

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AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19

Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III data from the Oxford University-led clinical trial in the UK, Brazil and South Africa, and a P-I/II trial in Japan PMDA recommends the use of Vaxzevria should be limited to …

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EMA backs safety of AZ COVID-19 jab in all age groups

The head of the EMA has reiterated that there is no evidence to limit the use of AstraZeneca’s COVID-19 vaccine in any age group, after Germany and Canada imposed restrictions in younger patients.  “Our position has not changed” from a safety update two weeks ago, said Emer Cooke at an EMA press conference today. “According …

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AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

Shots: The P-III D8110C00001 study involves assessing AZD1222 vs PBO in 32,449 participants in a ratio (2:1) aged ≥18yrs. across 88 trial centers in the US, Peru and Chile to prevent COVID-19. his primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from total participants The study showed 76% efficacy against symptomatic …

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AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: The P-III D8110C00001 study assessing AZD1222 (2 doses either 5 x1010 viral particles or saline PBO 4 wks. apart) vs PBO for the prevention of COVID-19. The interim analysis for efficacy was based on 32,449 participants aged ≥18 yrs. accruing 141 symptomatic infections in a ratio (2:1) across ~88 trial centers in and outside …

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States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme

The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the response to the pandemic in Europe.  Germany, France, Italy and Spain are among the member states that have announced a suspension of dosing with AZD1222 in the last 24 hours …

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AZ COVID jab efficacy debate is hindering EU’s vaccine drive

The spat between the EU and AstraZeneca over access to the company’s COVID-19 shot led to scathing remarks about its efficacy that now threaten to undermine the EU’s vaccination targets.  The European Commission approved AZ’s AZD1222 vaccine for use in the EU in all adults aged over 18 at the end of January, more than …

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EMA approves AZ’s COVID-19 vaccine – including for over-65s

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. The conditional marketing authorisation makes AZD1222 the third coronavirus vaccine to be approved for EU use after the Pfizer/BioNTech and Moderna shots, and …

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EU eyes tighter COVID-19 vaccine exports as access gets ugly

The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where supplies have been delivered so far.   Moreover, it plans to rush through legislation requiring that all companies producing vaccines against COVID-19 in the EU have to notify the Commission …

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EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month. The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting …

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AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday. The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million …

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AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Shots: The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses administered with an interval of between 4 & 12wks The authorization is based on independent advice from its CHM following a rolling review of trial data that included an interim …

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AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Shots: The results of an interim of P-III program demonstrated that AZD1222 is safe & effective at preventing symptomatic COVID-19 and hospitalization. The interim analysis for efficacy was based on ~11,636 participants accruing 131 symptomatic infections from the P-III UK and Brazil trials The 1EPs based on the pooling of two dosing regimens showed vaccine …

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‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot

AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident. According to Reuters, the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222. Results announced earlier this week showed that by giving …

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Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot. Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from …

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AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose …

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AZ, J&J COVID-19 vaccine trials okay to restart in US

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of  its coronavirus candidate JNJ-78436735, …

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AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A voluntary pause across all global studies was triggered on Sept …

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European regulators begin rolling review of AZ’s COVID-19 vaccine

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. …

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Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Shots: Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation The two companies may enter additional commercial manufacturing agreement as the candidate progresses over three years through Emergent’s …

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AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK The study demonstrated …

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