COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves

 

Positive topline results for Pfizer/BioNTech jab in five to 11-year-olds

21st September 2021

Results showed vaccine has favourable safety profile in this age group

Pfizer and BioNTech have announced that their COVID-19 vaccine is safe for use in children aged five to 11 years old.

Results from a Phase II/III trial showed a favourable safety profile and ‘robust’ neutralising antibody response in children aged five- to 11-years-old using a two-dose vaccine regimen, administered 21 days apart. The study tested a smaller dose – 10 µg – in this study compared to the higher dose – 30µg – used for people aged 12 years and older.

According to the companies, the antibody responses in the participants given the smaller dose were comparable to those seen in a previous study in people aged 16- to 25-years-old who were immunised with 30µg doses.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.

“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose,” he added.

Pfizer and BioNTech are planning to submit the data to the US Food and Drug Administration, European Medicines Agency and other regulators ‘as soon as possible’.

 

Novavax joins Oxford mix-and-match COVID-19 vaccine study in adolescents

17th September 2021

The Phase II clinical trial will include at least 360 adolescents aged 12-16 years old

Biotech company Novavax will participate in the Oxford University-led Com-COV3 study, which is comparing a mixed COVID-19 vaccine schedule in adolescents.

The Phase II clinical trial, funded by the UK Vaccines Taskforce (VTF) and National Institute for Health Research (NIHR), will include at least 360 adolescents aged 12-16 years old.

Participants will receive the Pfizer/BioNTech vaccine as a first dose and then will receive one of three different vaccines as a second dose at least eight weeks later.

This includes either a full or half standard dose of the Pfizer vaccine, a full dose of the Novavax vaccine NVX-CoV2373 or a half dose of the Moderna vaccine.

Pfizer and Moderna’s vaccine are licensed for emergency use, whereas Novavax is licensed only for use in clinical studies.

The study volunteers will be followed for safety and immune responses, with results expected within a few months.

“Expanding our understanding of how different COVID-19 vaccines can be used to implement flexible vaccine programmes across all age groups will be vital to ultimately controlling the pandemic,” said Gregory M. Glenn, president of research and development, Novavax.

“A mixed vaccination series could offer the potential to maximise the use of existing vaccine supply, increase the total number of individuals who can ultimately be vaccinated and accelerate rapid and equitable access across the globe,” he added.

 

UK terminates Valneva COVID-19 vaccine supply agreement

13th September 2021

Gov has alleged that the company breached its obligations under the agreement

The UK government has terminated its supply agreement with French firm Valneva for its COVID-19 vaccine candidate VLA2001.

According to Valneva, the UK government has alleged that the company breached its obligations under the agreement, which it ‘strenuously’ denies.

Previously, the UK government had ordered 60 million doses of VLA2001, with another deal penned in February taking the total ordered to 100 million doses.

On top of this, the UK government also retained options for a further 90 million doses of VLA2001 for supply between 2023 and 2025.

As pat of the Valneva deal, the UK government was set to expand the firm’s Scottish facility in Livingston.

“This is a blow for the facility in Livingston. We are very keen and will be reaching out to the company to try to get security and secure a future for that facility in Livingston; we hope that would be with Valneva,” Humza Yousaf, Scotland’s health secretary, told BBC Good Morning Scotland.

“Clearly, when it comes to their supposed alleged failure to meet their contract obligations, we obviously are looking for more information from the UK government and would expect that shortly,” he added.

VLA2001 is currently in Phase III clinical testing, with results expected early in the fourth quarter. These results will form part of the company’s rolling submission for condition approval of the vaccine with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

 

Gov’t consultation to consider mandatory COVID-19 vaccination for health staff

9th September 2021

Consultation will also ask for views on whether flu vaccines should be a requirement for health and care staff

The government has launched a six week consultation to consider mandatory COVID-19 vaccination for frontline staff working in health and care settings, the Department of Health and Social Care announced today.

The consultation will consider if requirements should apply for health and wider social care staff – i.e. those who work in contact with patients and people receiving care.

This would mean that only fully vaccinated staff – unless medically exempt – could be deployed to deliver health and care services.

On top of that, the consultation will also ask for views on whether flu vaccines should be a requirement for health and care staff.

In a statement, the DHSC said the proposals are being considered in a bit to protect vulnerable patients and staff.

“Many patients being treated in hospitals and other clinical settings are most at risk of suffering serious consequences of COVID-19, and we must do what we can to protect them,” said Health and Social Care Secretary Sajid Javid.

“It’s so clear to see the impact vaccines have against respiratory viruses which can be fatal to the vulnerable, and that’s why we’re exploring mandatory vaccines for both COVID-19 and flu.

“We will consider the responses to the consultation carefully but, whatever happens, I urge the small minority of NHS staff who have not yet been jabbed to consider getting vaccinated – for their own health as well as those around them,” he added.

Individuals working in care homes regulated by the Care Quality Commission (CQC) already now need to be fully vaccination as a condition of deployment, following a recent government consultation.

 

JCVI does not recommend COVID-19 vaccination for all 12 to 15-year-olds

6th September 2021

UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) announced last Friday (3rd September) that it does not recommend universal COVID-19 vaccination for healthy 12 to 15-year-olds ‘at this time’.

According to the JCVI, although the health benefits from COVID-19 vaccinations are marginally greater than the potential known harms, this margin of benefit is ‘too small’ to recommend vaccinations for this age group currently.

The JCVI added that considering the wider societal impacts of vaccination – including educational benefits – are outside its remit.

As such, the JCVI said the government may wish to seek further input on the wider impacts of vaccination in this age group from the UK’s chief medical officer.

The Department of Health and Social Care has since announced that the four chief medical officers will provide further advice on the vaccination of 12 to -15-year-olds.

The UK’s chief medical officer will launch the process of assessing the wider impact of universal COVID-19 vaccination in this population.

“People aged 12 to 15 who are clinically vulnerable to the virus have already been offered a COVID-19 vaccine, and today we’ll be expanding the offer to those with conditions such as sickle cell disease or type 1 diabetes to protect even more vulnerable children,” said Health and Social Care Secretary Sajid Javid.

“Along with Health Ministers across the four nations, I have today written to the Chief Medical Officers to ask that they consider the vaccination of 12 to 15-year-olds from a broader perspective, as suggested by the JCVI. We will then consider the advice from the Chief Medical Officers, building on the advice from the JCVI, before making a decision shortly,” he added.

 

JCVI advises booster COVID-19 jab for severely immunosuppressed

2nd September 2021

Offer is separate to potential booster programme

The Joint Committee on Vaccination and Immunisation (JCVI) has advised that people with severely weakened immune systems should have a third vaccine dose as part of their primary COVID-19 vaccination schedule.

According to the JCVI, this third dose should be offered to people over 12 who were severely immunosuppressed at the time of their first or second dose, including those with leukaemia, advanced HIV and recent organ transplants.

The decision is based on preliminary data from the OCTAVE trial, which showed that while almost everyone who was immunosuppressed mounted an immune response after 2 doses, in around 40% of people, the levels of antibodies were low.

The JCVI is awaiting further evidence to inform a decision on a potential booster programme for those with less serious immunosuppression.

Professor Wei Shen Lim, chair of COVID-19 immunisation for the JCVI, said: “We want people with severely suppressed immune systems to have the best chance of gaining protection from COVID-19 via vaccination. Therefore, we are advising they have a third vaccine dose on top of their initial two doses, as we hope this will reduce their risk of severe outcomes such as hospitalisation and death.”

 

GSK, SK to compare COVID-19 vaccine candidate to AZ’s jab

31st August 2021

Phase III trial will use AZ’s COVID-19 vaccine as an active comparator

GlaxoSmithKline (GSK) and SK bioscience have launched a Phase III trial of their adjuvanted COVID-19 vaccine candidate, which is set to compare the jab to AstraZeneca’s (AZ) vaccine.

The trial, which will enrol around 4,000 participants from various countries, will aim to evaluate SK’s COVID-19 vaccine candidate GBP510 in combination with GSK’s pandemic adjuvant.

The study will investigate GBP510’s safety and immunogenicity compared to AZ’s Oxford University-partnered COVID-19 vaccine, which will act as an active comparator in the trial.

According to GSK/SK, the study is one of the first global Phase III trials to compare two different COVID-19 vaccine candidates.

The launch of the Phase III trial comes following positive interim Phase I/II trial data, which showed that all participants who received the jab developed strong neutralising antibody response, with a 100% seroconversion rate.

On top of that, neutralising antibody titres were found to be between five and a maximum of eight times higher in individuals who had received GSK/SK’s vaccine compared to the sera from people who had recovered from COVID-19.

“While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world,” said Thomas Breuer, chief global health officer, GSK.

"We are grateful that we were able to advance to the Phase III study with the unprecedented support of global initiatives, including GSK, Coalition for Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda Gates Foundation (BMGF). Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510,” added Jaeyong Ahn, chief executive officer of SK bioscience.

GSK and SK are expecting results from the late-stage study in the first half of 2022 – if the trial yields positive results and wins regulatory approval, the companies are hoping the jab can be supplied ‘at scale’ through the COVAX vaccines sharing facility.

 

Home antibody tests for COVID-19 to be made available in UK

26th August 2021

Up to 8,000 people per day can access the tests

Up to 8,000 adults a day will be given free access to antibody tests through a new national surveillance programme, which will be launched by the UK Health Security Agency next week.

The aim is to help improve understanding of immunity against COVID-19 from vaccination and infection. This is the first time antibody tests have been made available to the general public. Until now, antibody testing has only been available to specific cohorts for clinical or research purposes.

From Tuesday 31 August 2021, anyone aged over 18 years old will be able to opt in to take part when booking a PCR test through NHS Test and Trace.

Individuals who opt in will then receive a positive PCR result will be sent two finger prick antibody tests to be completed at home and sent back to a lab for analysis.

The UK Health Security Agency, alongside NHS Test and Trace testing services, will monitor levels of antibodies in positive cases across the UK.

The data collected will be used to help estimate the numer of those who were infected with COVID-19, despite developing antibodies as a result of having a vaccine or previously catching coronavirus.

The initiative may also provide insight into any groups of people who do not develop an immune response.

Health and social care secretary Sajid Javid commented: “Our new national antibody testing will be quick and easy to take part in, and by doing so you’ll be helping strengthen our understanding of COVID-19 as we cautiously return to a more normal life.”

 

Study finds protection against COVID-19 ‘waning’ in fully vaccinated people

25th August 2021

The ZOE COVID Study app assessed data on positive COVID-19 PCR test results between May and July 2021

New real-world study data has found that protection against COVID-19 is ‘waning’ in individuals who have received two vaccine doses.

The ZOE COVID Study app assessed data on positive COVID-19 PCR test results between May and July 2021, with over a million people included having had two doses of either the Pfizer/BioNTech or AstraZeneca (AZ) vaccines.

Researchers found that protection following two doses of the Pfizer/BioNTech jab fell from 88% at one month to 74% at five to six months. A similar decrease was observed for those vaccinated with the AZ vaccine, with protection dropping from 77% to 67% within the same timeframe.

"Waning protection is to be expected and is not a reason to not get vaccinated. Vaccines still provide high levels of protection for the majority of the population, especially against the Delta variant, so we still need as many people as possible to get fully vaccinated,” said professor Tim Spector, lead investigator on the ZOE COVID Study app.

Interim advice issued in June by the Joint Committee on Vaccination and Immunisation (JCVI) outlined that any potential COVID-19 booster programme should be offered in two stages from September.

Under this proposal, the most at risk from serious disease would be the first to be offered the booster jabs, including care home residents, those over the age of 70 years old, frontline health and social care workers, the clinically extremely vulnerable and immunosuppressed adults.

Currently, the JCVI is reviewing ‘emerging scientific data’ before making its final recommendations for the booster COVID-19 vaccination programme.

 

Pfizer/BioNTech’s COVID-19 vaccine wins first full FDA approval

24th August 2021

Biologics License Application approved to prevent COVID-19 in individuals 16 years of age and older

Pfizer/BioNTech’s Comirnaty has become the first COVID-19 vaccine to win full approval from the US Food and Drug Administration (FDA).

In December 2020, the FDA approved an emergency use authorisation (EUA) for the Pfizer/BioNTech COVID-19 vaccine, based on preliminary data from a pivotal Phase III clinical trial.

As part of their Biologics License Application (BLA) for Comirnaty, Pfizer and BioNTech submitted a ‘comprehensive’ data package, including long-term follow-up data from the Phase III trial as well as manufacturing and facilities data.

The companies are also planning to submit an application for approval of a third booster dose of Comirnaty in individuals 16 years of age and older via a supplemental BLA.

On top of that, Pfizer and BioNTech also intend to submit another supplemental BLA to support full FDA approval of the vaccine in children aged 12 to 15-years-old, once the required data is available.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60% of eligible Americans are fully vaccinated, and infection, hospitalisation and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, chairman and chief executive officer, Pfizer.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the US since December 2020, and we look forward to continuing to work with the US government to reach more Americans now that we have FDA approval,” he added.

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