Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the...
The Pfizer/BioNTech COVID-19 vaccine – which requires ultra-cold storage – will now be allowed to be transported and stored at standard freezer temperatures for up to two weeks in the US.
Pfizer and BioNTech have begun evaluating the safety and immunogenicity of a third dose of their mRNA vaccine, to understand the effect of a booster on immunity against current and emerging virus variants.
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions....
Pfizer and BioNTech have submitted new stability data to the US Food and Drug Administration (FDA), showing that their vaccine can be stored at standard freezer temperatures for two weeks.
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
Three COVID-19 vaccine manufacturing sites are set to start production in France in the coming weeks: while the French government is seeking to boost further production with a €300m ($363m) initiative announced on Monday.
Johns Hopkins Medicine researchers have studied the reaction of nearly 200 solid organ transplant recipients to their first COVID-19 vaccine shot. The findings, they say, suggest that the Moderna and Pfizer/BioNTech mRNA vaccines can be safely given to...
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.
Australia’s Therapeutics Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine: making it the first available in the country.
The World Health Organization’s Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.
Pfizer and BioNTech have re-iterated that their COVID-19 vaccine appears to be effective against the UK strain, with the publication of new data today.
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.
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 FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.
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.
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
With the Pfizer/BioNTech COVID-19 vaccine authorized in the UK yesterday, the roll out of the first 800,000 doses will begin next week. 'We have spent months preparing for this day, so that as soon as we got the green light we would be ready to go,'...
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.
It’s been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates. Here's five key takeaways from this week's developments.
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.
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.
Pfizer’s CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate ‘soon after’ a safety milestone is reached in the third week of November.
The European Commission has concluded exploratory talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.
