COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves
J&J resumes roll-out of COVID-19 vaccine in EU
21st April 2021
EMA's safety committee has confirmed the overall benefit-risk profile of the jab
Johnson & Johnson (J&J) is planning to resume the roll-out of its COVID-19 vaccine in the EU following updated guidance from the European Medicines Agency’s (EMA) safety committee.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.
According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.
The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.
J&J will now resume shipments of its COVID-19 vaccine in the European Union, Norway and Iceland, with updated EMA and Healthcare Professionals guidance to become available to national healthcare authorities.
"The safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment," said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson.
"We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally. We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use,” he added.
In the US, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are currently reviewing the same blood clot cases.
Following an initial meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), another meeting has been scheduled for 23 April for further discussion of the blood clot cases.
NHS extends ‘COVID-friendly’ at-home cancer care
31st March 2021
Funding for effective, 'less risky' treatments extended until summer 2021
The NHS has announced that thousands of people will benefit from the extension of ‘COVID-friendly’ cancer treatments which can be taken at home.
Since April, approximately 8,000 people have benefitted from treatment swaps, to enable cancer treatment to continue during the COVID-19 pandemic, with over 250,000 people beginning treatment for cancer since the start of the pandemic.
The NHS will continue to fund effective and ‘less risky treatment[s]’ for patients during the pandemic, with access to these drugs now extended until summer and potentially continuing until the end of March 2022.
Among the options available are targeted hormone therapies such as enzalutamide (Xtandi; Astellas/Pfizer) for prostate cancer and broadened use of lenalidomide (Revlimid; Bristol Myers Squibb) for myeloma.
Some ovarian cancer patients will also be able to receive trametinib (Mekinist; Novartis) as a tablet alternative to chemotherapy, to help reduce the impact on their immune systems.
“Cancer has been a priority throughout the pandemic which is why NHS staff have fast-tracked patient access to more convenient and kinder treatments to provide as many people as possible with safe and effective care, even as the NHS cared for more than 380,000 people seriously ill with COVID-19,” said Peter Johnson, NHS clinical director for cancer.
“Extending the use of ‘Covid friendly’ treatments for cancer is another example of how we are embracing the full range of treatment options and bringing the NHS to patients at home in many cases,” he added.
GSK agrees to support manufacture of Novavax' COVID-19 vaccine
30th March 2021
British drugmaker will help to produce up to 60 million doses for use in the UK
GlaxoSmithKline (GSK) has agreed in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate – NVX-CoV2373 – for use in the UK.
GSK has agreed with Novavax and the UK government Vaccines Taskforce to provide fill and finish manufacturing capacity at its Barnard Castle facility in the North East of England, starting as early as May 2021.
Fill and finish is the completion stage of vaccine manufacturing – during this stage, vials of the final vaccine are prepared and packaged for distribution and use.
According to GSK, the parties will negotiate a final agreement to include additional terms and conditions, although technology transfer between the two companies is set to begin ‘immediately’.
The protein antigen component of NVX-CoV2373 is produced by Novavax’ manufacturing partner FUJIFILM Diosynth Biotechnologies at its site in Billingham, Stockton-on-Tees.
“I’m delighted by GSK’s investment, which shows the strength of UK manufacturing, and will further boost our vaccine rollout,” said Prime Minister Boris Johnson.
“The Vaccines Taskforce has worked hand in glove with business to successfully deliver vaccines to the whole of the UK, and this agreement will continue to support our approach. We remain on track to offer a first jab to all over 50s by 15 April, and all adults by the end of July, and I want to once again encourage everyone to come forward for a vaccine when you’re called,” he added.
The UK government has signed an advance purchase agreement with Novavax for 60 million doses of NVX-CoV2373.
GSK, Vir Biotech seek emergency use authorisation for COVID-19 antibody
29th March 2021
Companies are requesting emergency approval of drug for the early treatment of COVID-19
GlaxoSmithKline (GSK) and Vir Biotechnology have submitted a request to the US Food and Drug Administration (FDA), seeking an emergency use authorisation (EUA) for their COVID-19 antibody VIR-7831.
The EUA application is seeking authorisation for VIR-7831, an investigational dual-action monoclonal antibody (mAb), for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk of progression to hospitalisation or death.
The submission is based on an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial, which demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831 compared to placebo.
Following this positive result, the independent data monitoring committee recommended that the trial be stopped for enrolment, due to evidence of ‘profound efficacy’.
GSK and Vir Biotech added that data from the COMET-ICE trial will also form the basis of a biologics license application (BLA) submission to the FDA.
The companies are also continuing discussions with the European Medicines Agency (EMA) and other global regulators for the potential approval of VIR-7831 to treat patients with COVID-19.
AstraZeneca’s updated COVID-19 vaccine trial results show 76% efficacy
25th March 2021
Initial results from US trial published earlier this week said the vaccine was 79% effective
AstraZeneca (AZ) has published updated results from a US-based trial of its COVID-19 vaccine, after receiving criticism that initial data published earlier this week may have included ‘outdated information'.
On Monday, AZ said that its vaccine demonstrated 79% efficacy in the US trial, following a pre-specified interim analysis of the data, which had a cut-off of 17 February.
Following this, the US National Institute of Allergy and Infectious Diseases (NIAID) issued a statement saying that the trial’s data and safety monitoring board (DSMB) had expressed concerns about the initial data from AZ’s COVID-19 vaccine trial.
The DSMB expressed concerns that AZ may have included outdated information from the trial, which could have provided an ‘incomplete’ image of the efficacy data.
In response, AZ said it would ‘immediately’ engage with the DSMB to share the primary analysis with the up-to-date efficacy data.
The primary analysis demonstrated at 76% efficacy at preventing symptomatic COVID-19 – slightly lower than the previously reported 79% – although the updated results showed the vaccine was consistent at preventing severe or critical disease and hospitalisation, demonstrating 100% efficacy on this marker.
The updated results were comparable across age groups, with vaccine efficacy of 85% in adults aged 65 years and older.
“The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.
“We look forward to filing our regulatory submission for emergency use authorisation in the US and preparing for the rollout of millions of doses across America,” he added.
AZ to issue primary analysis for COVID-19 vaccine following ‘outdated information’ concerns
24th March 2021
US data and safety monitoring board expressed ‘concern’ over initial trial data
AstraZeneca (AZ) is planning to share the primary analysis from a US-based phase 3 trial of its COVID-19 vaccine following a statement issued by the US National Institute of Allergy and Infectious Diseases (NIAID) yesterday.
In the statement, NIAID said that the trial’s data and safety monitoring board (DSMB) had expressed concerns about the initial data from the COVID-19 vaccine trial.
According to the NIAID statement, the DSMB expressed concerns that AZ may have included outdated information from that trial, which could have provided an ‘incomplete’ image of the efficacy data.
NIAID urged AZ to engage with the DSMB to review the efficacy data and ensure the most up-to-date efficacy data is made public as soon as possible.
In response, AZ said that the data published on Monday for its vaccine were based on a pre-specified interim analysis cut-off of 17 February.
The company added that it had reviewed the preliminary assessment of the primary analysis, with the results being consistent with the interim analysis.
AZ is now completing the validation of the statistical analysis and will ‘immediately’ engage with the DSMB to share the primary analysis with the up-to-date efficacy data.
“We intend to issue results of the primary analysis within 48 hours,” said AZ.
AstraZeneca’s COVID-19 vaccine shows 79% efficacy in US trial
23rd March 2021
Jab was also found to have 100% efficacy at preventing severe disease and hospitalisation
The US-based Phase III trial of AstraZeneca’s (AZ) vaccine – AZD1222 – has demonstrated a vaccine efficacy of 79% at preventing symptomatic COVID-19.
In addition, the jab was also found to have 100% efficacy at preventing severe disease and hospitalisation in the late-stage study.
This efficacy was consistent across ethnicity and age – in participants aged 65 years and over demonstrating the vaccine efficacy was 80%.
AZ added that the vaccine was well tolerated, with no safety concerns related to the vaccine highlighted by the independent data safety monitoring committee (DSMB).
The DSMB also conducted a specific review of thrombotic events and cerebral venous sinus thrombosis (CVST).
They found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants who had received at least one dose of the vaccine, with no CVST events found in the trial.
The US Phase III trial included two doses administered at a four week interval, however previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy.
“We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.
“We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use,” he added.
UK and EU regulators reaffirm the safety of AZ/Oxford Uni’s COVID-19 vaccine
19th March 2021
MHRA and EMA conclude the vaccine's benefits continue to outweigh risks
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have reconfirmed the safety and efficacy of AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine.
The MHRA reviewed a small number of thromboembolic events in over 11 million people who have received AZ/Oxford’s vaccine in the UK.
The regulatory agency concluded that the benefits of the jab ‘far outweigh’ any risks following a ‘rigorous’ scientific review, AZ said in a statement.
Following this review, the MHRA added that there is no evidence that blood clots in veins are occurring more than what would be expected in the absence of vaccination.
A ‘detailed’ review of five reports in the UK of a rare and specific type of blood clot – known as sinus vein thrombosis – occurring with lowered platelets (thrombocytopenia) is ongoing.
However, the MHRA said that this has been reported in less than one in one million people vaccinated in the UK so far and can occur naturally, with no causal association with the vaccine established.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) also shared its conclusions, finding that there was no increase in the overall risk of blood clots with the AZ/Oxford vaccine.
The EU regulator also concluded that for the very rare cases of serious thromboembolic events with thrombocytopenia, a causal link with the jab is not ‘proven’, but is possible and so warrants further analysis.
The EMA’s safety committee PRAC reviewed in ‘extreme detail’ records of disseminated intravascular coagulation (DIC) and clots in the vessels draining blood from the brain (CVST) reported from EU member states – nine of which resulted in death and mostly occurred in people under 55, with the majority being women.
The committee’s experts said that because these events are rare and COVID-19 itself often causes blood clotting disorders in patients, it is ‘difficult’ to estimate a background rate for these events in people who have not received the jab.
They concluded, based on pre-COVID figures, that less than one reported case of DIC might have been expected by 16 March among people under 50 within 14 days of receiving the vaccine – whereas five cases had been reported.
For CVST, on average 1.35 cases could have been expected among this age group – by the same cut-off date there had been 12.
Ultimately, the committee concluded that the AZ/Oxford vaccine’s proven efficacy in preventing COVID-19-associated hospitalisation and death outweighs the ‘extremely small’ chance of developing either DIC and CVST.
In light of the findings, however, the EMA added that patients should be aware of the remote possibility of such conditions, and should seek immediate medical attention if symptoms associated with clotting problems occur.
The PRAC will conduct an additional review of these risks, including looking at the risks with other types of COVID-19 vaccines.
“Our thorough and careful review, alongside the critical assessment of leading, independent scientists, shows that there is no evidence that that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine,” said June Raine, chief executive of the MHRA.
“Given the extremely rare rate of occurrence of these CSVT events among the 11 million people vaccinated, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects.
“You should therefore continue to get your jab when it is your turn,” she added.
GSK, Medicago launch late-stage trial of plant-derived COVID-19 vaccine
17th March 2021
Vaccine candidate has previously been granted FDA fast track designation
GlaxoSmithKline (GSK) and Canadian biopharma company Medicago have launched a Phase III trial of their adjuvanted plant-derived COVID-19 vaccine candidate.
The vaccine candidate uses Coronavirus-Like-Particle (CoVLP) technology, composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) administered alongside GSK’s pandemic adjuvant.
Medicago said it has received approval from Canadian and US regulatory authorities to begin enrolment of healthy adults into the Phase III trial based on ‘positive interim Phase II results’.
The adjuvanted plant-derived vaccine candidate received a fast track designation from the US Food and Drug Administration (FDA) in February 2021.
The Phase III portion of the study will evaluate the efficacy and safety of the adjuvanted CoVLP formulation and will enrol up to 30,000 participants.
Initially, the trial will enrol healthy adults aged 18 to 65 years old, followed by elderly adults aged 65 and over and adults with comorbidities.
The companies added that the Phase II trial of the vaccine is nearing completion, with results expected to be made public in April 2021.
“We are pleased to take the significant step of initiating the Phase III clinical trial at sites around the world,” said Takashi Nagao, chief executive officer and president of Medicago.
“This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK,” he added.
Frontline charities sign open letter backing COVID-19 vaccination drive
16th March 2021
Over 20 charities are encouraging people with underlying conditions to receive a jab
A partnership of frontline health charities has signed an open letter encouraging people with underlying conditions to book in for a COVID-19 vaccine.
The charities, including Mencap, Diabetes UK and Lupus UK, have urged people with conditions including cancer, diabetes and heart disease to protect themselves and others around them from the coronavirus by receiving a vaccine.
Although over half of those in this priority group – known as cohort six – have already received their first vaccine dose, the charities’ letter is ‘hoped’ to further increase take-up among this group.
Cohort six includes individuals aged 16 to 64 years old who have certain long-term conditions, identified by the Joint Committee on Vaccination and Immunisation (JCVI), that puts them at a higher clinical risk from COVID-19.
It also includes carers who are eligible for a carer’s allowance, as well as those who are the sole or primary carer of an elderly or disabled person who has a higher risk of COVID-19 mortality.
“This open letter should help to reassure those with any concerns the vaccine is safe and supported by more than twenty of our most trusted charities,” said Nadhim Zahawi, Minister for Vaccines.
“I would like to thank them all for backing this life-saving campaign and offering their expertise and assistance to support the largest medical deployment in British history,” he added.
The Department of Health and Social Care (DHSC) said that the charities who have signed the open letter are among 22 organisations that have joined a partnership in support of the safety and effectiveness of the vaccine.
“The vaccines that have been approved for use in the UK have met the strict safety standards set by the medicines regulator on safety, quality and effectiveness,” the charities wrote in the open letter.
“To protect yourself and your family, friends and colleagues, you still need to follow the current government guidance on social contact after receiving your vaccine.
“Please come forward to have the jab. It will help save lives and offers the best form of protection from this terrible virus,” they added.