The world's first human challenge trial in which volunteers were deliberately exposed to Covid-19 to advance research into the disease was found to be safe in
healthy young adults, one of the companies running the study said on Wednesday.
The data supports the safety of this model which could theoretically provide a "plug and play" platform for testing therapies and vaccines using the original
Covid-19 strain as well as variants of the virus, Open Orphan, which carried out the study, said in a statement.
Open Orphan is running the project, launched a year ago, with Imperial College London, the UK government's vaccines task force and the clinical company hVIVO.
The trial infected 36 healthy male and female volunteers aged 18-29 years with the original SARS-CoV-2 strain of the virus and closely monitored them in a controlled
quarantined setting. They will be followed up for 12 months after discharge from the quarantine facility.
British drugmaker AstraZeneca says it's confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all
known virus variants.
Laboratory studies show the antibody, called AZD3152, neutralises all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment
available by the end of this year, the company's vaccines head Iskra Reic said on Tuesday (April 18).
AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023.
These types of therapies are most needed for people with compromised immune systems, either because of underlying conditions or because they are undergoing immune
suppressing treatments. They account for nearly 2% of the global population.
AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio.
The British drugmaker will likely make future investments like its current partnerships with RQ Bio but did not have any deals to announce, said Reic, a long-time
AstraZeneca executive who has led the company's vaccines and immune therapies unit since it was formed in late 2021, during the pandemic.
Even as the UK agrees deals for 14 million additional vaccine doses from Moderna and Pfizer, the Royal Pharmaceutical Society has renewed its calls for community pharmacies in England to play an increased role in delivering booster jabs for Covid-19.
"Pharmacists and pharmacy teams across the health service in England have been crucial to the success of the flu and Covids-19 vaccination programmes from the outset," said Thorrun Govind, chair of the RPS in England, who has been making a case on national television for an increased role of the profession.
She added: "They continue to go above and beyond to support patient care, engaging with local communities and helping to overcome vaccine hesitancy.
"They've already done so much this year to look after patients in really difficult circumstances, but many will be ready to rise to the challenge of this new national effort."
An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights
for Covid-19 interventions between the pharmaceutical industry and developing nations endures.
At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries
when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected.
In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry
collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA).
The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved
in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck.
The declaration is not legally binding.
However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.
The National Health Service will begin its autumn Covid vaccine program next week, a month earlier than planned in response to the spread of a new variant
dubbed Pirola. Covid vaccines will be administered to care home residents and housebound individuals from Monday onwards, while over-65s and other vulnerable
groups will receive their appointments the week after.
On Aug. 30, NHS England shifted the autumn vaccination drive to start on September 11 in response to the new Covid-19 variant, BA.2.86, detected on August 18.
The primary groups can book through a national system upon receiving an invitation from the NHS. Some people may get an earlier call from their GP, and a few have
already scheduled Covid vaccinations alongside their flu jabs.
The NHS will begin inviting other eligible groups from Sept. 18. However, it is important to note that not everyone will receive a call at the same time. These
groups will include individuals aged 65 and over, those aged six months to 64 years in a clinical risk category, frontline health and social care workers, and
individuals aged 12 to 64 who are carers or household contacts of those with immunosuppression.
US biotech firm Moderna will build a new research and manufacturing centre in Britain to develop vaccines against new Covid-19 variants, other respiratory
illnesses and help improve readiness for any future pandemics.
The facility is expected to start producing shots in 2025 and Britain has made a commitment to buy Moderna's vaccines for the next decade under the agreement.
Moderna's Covid-19 vaccines, which use messenger RNA (mRNA) technology, were among those deployed in Britain to tackle the crisis and enable prime minister Boris
Johnson to reopen the economy from stringent lockdowns.
Moderna chief executive Stephane Bancel said the priority was to develop a shot combining refreshed boosters against Covid, flu and Respiratory Syncytial Virus (RSV).
"By building a plant in the UK, we are also providing the UK Government - which has a long term partnership with us, with this agreement - with the ability to be
pandemic ready," Bancel said on Wednesday.
There is a realistic possibility of large waves of Covid-19 infection in the future in Britain and such waves might even be considered likely, epidemiologists who model the Covid-19 pandemic to inform government advice have said.
Prime minister Boris Johnson has ditched legal restrictions in England, saying that, while the pandemic was not over, Britain needs to learn to live with Covid.
The Scientific Pandemic Influenza Group on Modelling, Operational sub-group (SPI-M-O) said the emergence of new viral variants was the biggest unknown factor in the medium-to-long term, along with waning population immunity and changes in mixing patterns.
"Large future waves of infection that need active management to prevent detrimental pressure on the health and care sector are, at least, a realistic possibility (high confidence) or likely (medium confidence)," SPI-M-O said in a consensus statement published on Friday.
Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus.
Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults.
The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original
2020 virus, it said.
The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4
and BA.5.
"The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive
June Raine said in a statement.
"What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."
Deviating from the initial schedule to kick off the flu and Covid-19 vaccination campaigns in October, the NHS England has announced that the autumn
vaccination drive will commence sooner than expected in England, starting on September 11. This decision was taken as a precaution in response to a new Covid-19
variant.
The precautionary measure is being taken as the Department of Health and Social Care and the UK Health Security Agency examined the variant BA.2.86, which was first
detected in the UK on Friday, August 18, 2023, the NHSE said on Aug. 30.
While NHS England had previously announced that vaccinations for both NHS programmes would begin on October 2 for residents of older adult care homes, appointments
for other eligible groups were scheduled for the following week, starting on October 7. This decision prompted community pharmacy leaders to denounce the delayed
start of the flu service as 'unacceptable'.
UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old.
The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory
Agency (MHRA) announced on Wednesday (December 22).
Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data.
These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said.
Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.
Covid-19 booster jab can now be administered sooner than six months after the second dose to certain vulnerable people as guideline in the UK Health Security
Agency (UKHSA) Green Book has been updated.
With the change in the guidance, care home residents who have been given their second vaccine dose at different times will be able to be jabbed in the same session,
as long as it has been at least five months since their last dose.
It may also help with other vulnerable groups, such as housebound patients to have their flu and Covid-19 vaccines at the same time.
The move will also benefit those who are about to receive immunosuppressive treatment as they can get the booster from a minimum of four months after their second dose.
Health secretary Sajid Javid said: "This updated guidance will ensure healthcare professionals have the necessary flexibility in the booster programme, allowing more
vulnerable people to be vaccinated where it makes operational sense to do so."
Vaccines minister Maggie Throup also encouraged eligible people to book their booster jab and secure protection.
The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday authorised a Covid-19 vaccine for infants as young as six months, opening the door
for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees.
The regulator authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on
an ongoing clinical trial involving 4,526 participants.
Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be
used as part of the national vaccination programme.
The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections
in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.
A new study has revealed that the risk of death from COVID-19 decreases significantly after vaccination, but this protection diminishes after six months,
providing evidence for continued booster doses.
Researchers from the UK Health Security Agency (UKHSA), who analysed more than 10 million cases of COVID-19 in adults in England between May 2020 and February
2022, found a clear association between vaccination and reduced mortality.
But they also highlighted a crucial timeframe - within six months of the last vaccine dose - when Case Fatality Risk (CFR) - the proportion of cases that resulted
in death - was consistently at its lowest across all age groups. After this, the protective benefit of the vaccine began to wane and CFR increased.
Britain's Covid booster campaign is set to kick off this September, after the country became the first in the world to approve an Omicron-adapted shot.
Around 26 million people in Britain are estimated to be eligible for an autumn Covid-19 booster, having had at least two Covid vaccine doses already, a UK Health
Security Agency (UKHSA) spokesperson said.
The preference is to deploy what is known as a "bivalent vaccine" that targets both the original virus and the Omicron variant through the autumn campaign, but that
will depend on the health regulator (MHRA) approving such shots and the state of vaccine supplies.
The UK's Joint Committee on Vaccination and Immunisation (JCVI) has advised boosters should be given to over-50s, individuals in clinical risk groups, frontline
workers and care-home staff ahead of the winter, when respiratory viruses are typically at their peak.
On Monday (August 15), the MHRA gave Moderna's bivalent shot conditional approval.
The endorsement of the vaccine is based on data that showed it produced a marginally better immune response against some Omicron variants, versus the original novel
coronavirus - although whether that translates into stronger protection against serious disease is unclear.
70 per cent of community pharmacies still waiting for government nod to start Covid booster jabdesc-Nearly 70 per cent of community pharmacies in England that offered to participate in the Covid-19 booster programme are still waiting for approval or have
been refused, ministers admitted on Monday (December 13).
The Liberal Democrats' health spokesperson, Daisy Cooper, exposed the low approval rate and long delays through a written parliamentary question to the health secretary as to "how many community pharmacies were providing Covid-19 vaccinations as of 3 December 2021."In response vaccines minister Maggie Throup said: "As of the end of September 2021, 4,733 contractors submitted 5,376 expressions of interest to take part in the booster vaccination programme, with 1,454 accepted."She added: "As of 3 December 2021, 1,336 community pharmacy vaccination sites were actively providing the service."
Some applications were decided by NHS England rather than the Department of Health and Social Care (DHSC).
Britain has approved a new coronavirus vaccine by the Austrian-French drugmaker Valneva.
"An approval has been granted after the Valneva Covid-19 vaccine was found to meet the required safety, quality and effectiveness standards," the Medicines and
Healthcare products Regulatory Agency said in a statement on Thursday (April 14), adding: "It is also the first, whole-virus inactivated Covid-19 vaccine to gain
regulatory approval in the UK."
In vaccines such as Valneva's VLA2001, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response. It is seen by some as having the potential to win over people wary of some which use new mRNA technology.
Valneva CEO Thomas Lingelbach said that "this authorisation could pave the way for the availability of an alternative vaccine solution for the UK population."
Covid-19 vaccines made by Pfizer and Moderna that use mRNA technology provide the biggest boost to antibody levels when given 10-12 weeks after the second dose, a new study has found.
The "COV-Boost" study was cited by UK officials when they announced that Pfizer and Moderna were preferred for use in the country's booster campaign, but the data has only been made publicly available now.
The study found that six out of the seven boosters examined enhanced immunity after initial vaccination with Pfizer-BioNTech's vaccine, while all seven increased immunity when given after two doses of AstraZeneca's vaccine.
"A third dose will be effective for many of the vaccines we've tested and in many different combinations," Professor Saul Faust, an immunologist at the University of Southampton and the trial's lead, told the media.
Pharmacy teams are being encouraged to support the ground-breaking Platform Adaptive trial of Novel antivirals for early treatment of Covid-19 In the Community (PANORAMIC) study by raising awareness among patients.
The study aims to find out whether new antiviral treatments can help Covid-19 patients avoid hospital admission and support a quicker recovery.
The PANORAMIC trial will allow researchers to gather data on the potential benefits of treatments to patients and will help the NHS to develop plans for rolling out the products to further patients in 2022.
Anyone over the age of 50 or between 18 to 49 with certain underlying health conditions can participate in the trial after receiving a positive PCR or lateral flow test result for Covid-19.
People who wish to participate in the trial can sign up themselves through the study's website and may be contacted by a member of the clinical team in a general practice that has been set up to deliver the PANORAMIC trial.
Britain will offer a Covid-19 booster shot to all adults and could halve the dose interval for booster jabs from six to three months in a bid to accelerate its vaccination programme amid concern over the new Omicron coronavirus variant, as number of new cases found in the country rise.
The move, backed by a scientific advisory body and Health Secretary Sajid Javid, comes as ministers scramble to react swiftly to the new variant, which was first detected in South Africa.
Prime minister Boris Johnson has responded to the emergence of Omicron by making mask-wearing compulsory in shops and on public transport in England.
Until now, only adults in the UK aged 40 and above were eligible for a booster dose six months after their last.
But that timeframe will now be halved to three months, alongside the programme's expansion to all over-18s, with priority given to older people.
"These measures will protect more people, more quickly and make us better protected as a nation," Javid told MPs.
Labour Party leader Keir Starmer leader has tested positive for Covid-19 for a second time, a spokesperson confirmed on Wednesday (January 5).
Starmer had been due to face prime minister Boris Johnson at a question and answer session in parliament later today. His deputy, Angela Rayner, will take his place, the spokesperson added.
Starmer had tested positive for Covid-19 last October and self-isolated four times after coming into contact with other positive cases on several occasions.