Novavax has started sharing early clinical data for its COVID-19 vaccine with health authorities in the UK, EU, US and Canada as it starts the rolling review process in these jurisdictions.
Pfizer and BioNTech now plan to manufacture two billion doses of their mRNA COVID-19 vaccine in 2021: up from the previous goal of 1.3 billion doses. Pfizer is forecasting $15bn in sales from the vaccine this year.
Johnson & Johnson intends to file for US Emergency Use Authorization (EUA) for its COVID-19 vaccine in early February, having reported the vaccine is 66% effective at preventing moderate to severe COVID-19.
Novavax’s COVID-19 vaccine showed 89.3% efficacy in its Phase 3 UK trial: including against the UK variant. Meanwhile a Phase 2b trial suggests 60% efficacy against the South African variant. “Our vaccine is the first to demonstrate significant clinical...
Advice published by the World Health Organization today says the two doses of the Moderna vaccine should be administered 28 days apart; but this interval can be extended up to 42 days if necessary.
The British Medical Association (BMA), the trade union and professional body for doctors in the UK, is calling for the delay between Pfizer/BioNTech COVID-19 vaccine doses to be reduced from 12 weeks to six weeks.
Australia’s Therapeutics Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine: making it the first available in the country.
VBI Vaccines is due to start a Phase 1/2 study of a coronavirus vaccine candidate in Q1 2021, after a preclinical hamster challenge study demonstrated ‘robust immunogenicity and efficacy’.
We take a look at some of the COVID-19 vaccine candidates moving through Phase 1 and 2 clinical trials - and how they could offer a point of difference to authorized vaccines.
The European Commission has set out steps to ramp up production of COVID-19 vaccines; tackle issues in the supply chain; and boost vaccination campaigns.
At the end of December, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated its advice on the Pfizer/BioNTech vaccine: saying that those with unrelated allergies could receive it. But this announcement did not receive as...
The World Health Organization’s vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
Akston Biosciences has announced a strategic partnership with LakePharma to manufacture commercial quantities of its COVID-19 vaccine candidate, as the room temperature stable vaccine gears up to begin Phase 1/2 clinical trials this month.
The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a ‘significant risk’ of undermining vaccination efforts.
People who have been infected with SARS-CoV-2 retain immune memory to protect against reinfection for 'at least eight months', according to Australian scientists. "This research is the strongest evidence for the likelihood that vaccines...
More than 360,000 people have signed up to the UK’s registry of people interested in participating in vaccine trials: the world’s first database of its kind. The UK is also exploring other measures – such as human challenge trials - to boost clinical...
BioNTech's CEO says it is highly likely that the Pfizer/BioNTech vaccine will be able to deal with the new variant that has emerged in the UK. And a new vaccine could be developed within six weeks if needed.
The European Medicines Agency (EMA) has recommended authorization of the Pfizer/ BioNTech COVID-19 vaccine: paving the way for the first marketing authorization of a COVID-19 vaccine in Europe.
New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
The US has started COVID-19 vaccinations this morning: after the Pfizer/BioNTech vaccine was granted Emergency Use Authorization (EUA) by the FDA on Friday.
The UK’s MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.
AstraZeneca and the University of Oxford's COVID-19 vaccine candidate threw up a surprise last month when a lower initial dose of the two-dose vaccine showed higher efficacy. More detailed results from this interim analysis, now peer-reviewed and...
Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.
Pfizer and BioNTech announced on Friday [20 November] they are submiting a request for Emergency Use Authorization for their COVID-19 vaccine to the US FDA: saying the vaccine could be in use by mid-December.
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
Pfizer has revised the efficacy figures for its COVID-19 vaccine candidate – now stating the vaccine is 95% effective – with its Phase 3 study meeting all primary efficacy endpoints.
The European Commission has reached an agreement with CureVac for up to 405 million doses of its mRNA-based COVID-19 vaccine candidate: representing the biggest COVID-19 vaccine deal the Commission has inked so far.
Moderna’s mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
Sinovac’s Phase 3 COVID-19 vaccine trial has been put on hold in Brazil after a serious adverse event. But in a statement this morning, the company says the event is not related to the vaccine.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavax’s COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. “Today is a great day for science and humanity,” says the company’s CEO.
