Pharmaceutical Market Europe • October 2023 • 10-11

CORONAVIRUS NEWS

Moderna’s updated COVID-19 vaccine approved by MHRA

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Moderna’s updated COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in individuals aged six months and older.

In line with previous recommendations from regulators and global public health bodies, the company’s monovalent ‘Spikevax’ vaccine has been adapted to target the XBB.1.5 Omicron variant.

In addition to XBB sub-lineages XBB.1.5, XBB.1.16 and XBB.2.3.2, the vaccine has also demonstrated an 8.7 to 11-fold increase in neutralising antibodies against other currently circulating variants, including BA.2.86, which is currently being tracked by global health authorities, and the EG.5 and FL.1.5.1 strains.

Stephen Hoge, president of Moderna, previously said that the promising results shared by the company demonstrate that its updated vaccine “generates a strong human immune response against the highly mutated BA.2.86 variant”.

“Taken together with our previously communicated results showing a similarly effective response against EG.5 and FL.1.5.1 variants, this data confirms that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the [autumn] vaccination season,” he said.

Moderna’s vaccine has also recently been recommended by the European Medicines Agency’s human medicines committee for use in those aged six months and older.


FDA approves updated COVID-19 vaccines to target XBB.1.5 Omicron variant

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The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer/BioNTech and Moderna to more closely target currently circulating variants.

In line with previous recommendations from the FDA’s vaccines advisory committee, the vaccines have both been adapted to include a monovalent component that corresponds to the XBB.1.5 Omicron variant.

The mRNA vaccines are each approved for individuals aged 12 years and older and are authorised under emergency use for those aged six months to 11 years.

The FDA said it is “confident in the safety and effectiveness” of the updated vaccines and that the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals aged six months and older outweigh their risks.

Unless a significantly more virulent variant emerges, the FDA said it expects that COVID-19 vaccines will need to be updated annually, as is done for the seasonal flu vaccine.

Pfizer and Moderna said previously that their updated vaccines were effective against the BA.2.86 subvariant that is currently being tracked by global health authorities.

The vaccines have also been shown to generate strong responses against other currently circulating variants, including the EG.5 ‘Eris’ strain, which was designated by the World Health Organization as a ‘variant of interest’ in August.


Pfizer and BioNTech’s adapted COVID-19 vaccine approved by MHRA

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Pfizer and BioNTech’s Omicron XBB.1.5-adapted COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in individuals aged six months and older.

The approval comes after the vaccine, known as Comirnaty Omicron XBB.1.5, met the MHRA’s standards of safety, quality and effectiveness against the circulating Omicron XBB.1.5 subvariant.

The vaccine also showed effectiveness against EG.5.1 – otherwise known as ‘Eris’, the ‘variant of interest’ listed by the World Health Organization – as well as other currently circulating strains.

Working in the same way as the original vaccine, the updated vaccine causes the immune system to produce antibodies and blood cells that work against the virus.

The new approval came shortly after the European Commission approved the updated vaccine. The EU regulator’s decision followed a positive opinion from the European Medicines Agency’s human medicines committee.

The decision was based on results from preclinical data, which showed that the adapted vaccine generated a substantially improved response against multiple XBB sub-lineages of the SARS-CoV-2 virus variants in comparison to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said: “The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalisation.”


NHS starts winter programme
early for COVID-19 vaccinations

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NHS England has announced that bookings for COVID-19 vaccines have now opened as part of its winter vaccination programme to tackle the new COVID-19 variant.

Millions of eligible people in England can now book their vaccine via the NHS website, the NHS app or by calling 119 for free if they do not have access online.

People aged 65 and over, pregnant women and those with underlying health conditions are now receiving invitations from the NHS to get their COVID-19 and flu vaccines.

The programme was previously set to begin in October, but was brought forward following the emergence of a new COVID-19 variant, BA.2.86.

Currently, over 30 million people in England are eligible to receive a flu vaccine and over 20 million are able to get a COVID-19 vaccine.

On 11 September, care home residents and individuals who are housebound began receiving their COVID-19 and flu vaccinations.

Other groups who are eligible for this year’s vaccination campaign include frontline health and social care staff, unpaid carers and household contacts of those at risk.

For individuals aged under 18 years, COVID-19 vaccinations will begin later this year, and the NHS will notify eligible families when bookings are open.


US CDC recommends updated COVID-19 vaccines for autumn/winter season

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The US Centers for Disease Control and Prevention (CDC) has recommended that everyone aged six months and older get an updated COVID-19 vaccine to protect them against COVID-19 illness over autumn and winter.

This is the first autumn and winter virus season in the US where vaccines are available for COVID-19, respiratory syncytial virus (RSV) and influenza – the three viruses responsible for most hospitalisations.

Unlike other countries, including the UK, the US has not prioritised the vaccines specifically for high-risk populations.

Due to new strains of COVID-19 appearing, protection from previous COVID-19 vaccines has declined over time.

The updated vaccines are set to restore protection and provide enhanced protection against currently circulating variants.

For most people in the US, COVID-19 vaccines are free to receive and covered by the majority of health insurance plans.

Those who do not have health insurance or have health plans that do not cover COVID-19 vaccine costs can receive a free vaccine from their local health centres, state, local, tribal or territorial health departments, and pharmacies participating in the CDC’s Bridge Access Programme.

As part of the Vaccines for Children programme, eligible children can receive the vaccine from a provider enrolled in the programme.


MIT researchers design more powerful RNA vaccines for COVID-19

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Researchers at the Massachusetts Institute of Technology (MIT) have designed a more powerful COVID-19 RNA vaccine to produce a stronger immune response at a lower dose.

In the study funded by the National Institutes of Health and Translate Bio, the researchers engineered both the nanoparticles used to deliver the COVID-19 antigen and the antigen itself to boost immune response without needing a separate adjuvant.

After testing on mice, the new vaccine produced ten times more antibodies compared to mice given the unadjuvanted COVID-19 RNA vaccines and provoked a stronger response in T cells, which play an important role in combating the SARS-CoV-2 virus.

When administered intranasally, the researchers discovered a similarly strong immune response in the mice when compared to the traditional intramuscular vaccination.

Intranasal vaccination could potentially eradicate COVID-19 at the mucous membrane before it enters the body and “may also be easier to administer to many people since they don’t require an injection”, explained senior author of the study, Daniel Anderson.

The researchers are now planning to test the effectiveness and safety of the new vaccine formulation alongside healthcare companies in large animal models, with the view to eventually test on human patients.

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