Archive


Category: Comirnaty

  • Pfizer makes non-profit pledge for low-income nations

    US pharma giant Pfizer has said it will sell some of its patented medicines at non-profit prices to 45 of the world’s poorest countries – including new launches. The initiative will focus on infectious diseases, cancer, inflammation, rare diseases and women’s health, and will include its BioNTech-partnered COVID-19 vaccine Comirnaty as well as oral antiviral […]

  • EU says not enough evidence to warrant fourth COVID jabs

    It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty  or Moderna’s SpikeVax – the preferred […]

  • Moderna follows Pfizer in asking FDA for second COVID booster okay

    Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech which filed their Comirnaty shot earlier this week. There’s one big difference though – Pfizer is seeking a green light for second booster dose of Comirnaty for people aged 60 […]

  • COVID vaccines not linked to excess deaths, says CDC

    There is no evidence that vaccination with either the Pfizer/BioNTech or Moderna’s mRNA-based COVID-19 vaccines led to the death of patients, says a study by researchers at the Centres for Disease Control and Prevention (CDC). The analysis of data from US adverse event monitoring systems comes from the first six months after vaccination with the […]

  • COVID jabs now offered to all children aged 5 to 11 across UK

    England and Northern Ireland have followed Wales and Scotland in offering healthy children aged between five and 11 a low-dose COVID-19 vaccine, making vaccination an option for a younger age group across the UK. Health Secretary Sajid Javid says the rollout will be “non-urgent”, and parents would be able to decide whether or not the […]

  • Pfizer’s COVID boom goes on, as it eyes $22bn in Paxlovid sales this year

    Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. The massive windfall revenues will drive its sales up towards the $100 billion mark – it’s estimating a range of $98 to $102 billion – up […]

  • FDA clears Pfizer, BioNTech COVID booster for younger teens

    The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses […]

  • Patients ‘29% less likely to be hospitalised with Omicron’

    Data from a real-world study South Africa has indicated that the Omicron variant of COVID-19 is 29% less likely to cause hospitalisation among infected adults than other strains – although the researchers behind the work stress the findings are preliminary. The results – released by healthcare insurance group Discovery SA and the South African Medical […]

  • Omicron may evade Pfizer/BioNTech COVID jab, says study

    Preliminary study results from South Africa have suggested that antibodies stimulated by Pfizer and BioNTech’s Comirnaty are less effective against the new COVID-19 variant Omicron. A study by the African Health Research Institute (AHRI) has found that the less of immune protection was “extensive but incomplete,” meaning that some level of immunity was retained against […]

  • EU authorises first COVID-19 vaccine for 5 to 11 year olds

    The European Medicines Agency (EMA) has approved Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children between the ages of five and 11, as EU countries struggle to cope with rising infection rates. The EU regulator said that the under-12s should get a lower dose of the vaccine – 10 mcg rather than 30 mcg – […]

  • FDA delays review of Moderna COVD jab in adolescents

    The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation in people receiving the shot. The decision leaves Moderna playing catch-up with Pfizer and BioNTech, whose Comirnaty vaccine was approved for […]

  • CDC director backs COVID-19 jab for 5 to 11s, plus a fourth shot

    The US looks set to see a big expansion of the country’s COVID-19 vaccination drive, with shots looking likely for children aged five to 11 as well as a fourth dose for adults who are immunocompromised. FDA advisors gave a green light to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children in that younger age […]

  • FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids

    FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending […]

  • EU backs broader use of Comirnaty as COVID booster than US

    The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. The regulator’s human medicines committee (CHMP) said that a third […]

  • FDA approves Pfizer COVID booster jabs for higher-risk groups

    Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech’s COVID-19 vaccine, the FDA has followed through and cleared the shot. The FDA has amended the emergency use authorisation (EUA) for Comirnaty in line with its experts’ advice – for people aged over 65 and other adults at […]

  • Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

    With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this […]

  • Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

    With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this […]

  • EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

    The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes […]

  • FDA grants full approval to Pfizer/BioNTech COVID jab

    Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, […]