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Commission approves contract with BioNTech-Pfizer alliance to ensure access to a potential vaccine

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European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

Today’s contract with the BioNTech-Pfizer alliance builds upon the broad portfolio of vaccines to be produced in Europe, including the already signed a contracts with AstraZeneca, Sanofi-GSK and Janssen Pharmaceutica NV, and the concluded successful exploratory talks with CureVac and Moderna. This diversified vaccines portfolio will ensure Europe is well prepared for vaccination, once the vaccines have been proven to be safe and effective.

President of the European Commission, Ursula von der Leyen, said:  “In the wake of Monday’s promising announcement by BioNTech and Pfizer on the prospects for their vaccine, I’m very happy to announce today’s agreement with the European company BioNTech and Pfizer to purchase 300 million doses of the vaccine. With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials phase. Once authorised, they will be quickly deployed and bring us closer to a sustainable solution of the pandemic.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “A safe and effective vaccine is the only lasting exit strategy from the pandemic, and is at the centre of our European Vaccine Strategy. Today’s agreement follows the encouraging first indications from the clinical trial results and is further evidence of our commitment to putting more Europe in the area of health. It is a very telling example of what the EU can achieve when working together, as a Union, and a case in point of what a future European Health Union will be able to deliver.”

BioNTech is a German company working with US-based Pfizer to develop a new vaccine based on messenger RNA (mRNA). mRNA plays a fundamental role in  biology, transferring instructions from DNA to cells’ protein making machinery. In an mRNA vaccine, these instructions make harmless fragments of the virus which the human body uses to build an immune response to prevent or fight disease.

The Commission has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, the companies’ experience in vaccine development and their production capacity to supply the whole of the EU.

Background

The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements. Funding provided is considered as a down-payment on the vaccines that will actually be purchased by Member States.

Since the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers, these agreements will therefore allow investments to be made that otherwise might not happen.

Once vaccines have been proven to be safe and effective and have been granted market authorisation by the European Medicines Agency, they need to be quickly distributed and deployed across Europe. On 15 October, the Commission set out the key steps that Member States need to take to be fully prepared, which includes the development of national vaccination strategies. The Commission is putting in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies.

The European Commission is also committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it has raised almost €16 billion since 4 May 2020 under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery and has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere. As part of a Team Europe effort, the Commission announced is contributing with €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.

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COVID-19: WHO expresses hope worst of Omicron wave is over

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Omicron continues to sweep the world, but cases seem to have peaked in some countries, which gives the head of the World Health Organization (WHO) hope that the worst of this latest wave of COVID-19 is over. 

Briefing journalists in Geneva, Tedros Ghebreyesus said that more than 18 million cases were reported last week, and the pandemic itself is far from over, so no country is out of the woods yet.

The number of deaths remains stable, but the agency is concerned about the impact the variant is having on already exhausted health workers and overburdened health systems.

“I remain particularly concerned about many countries that have low vaccination rates, as people are many times more at risk of severe illness and death if they’re unvaccinated”, Tedros said. 

Omicron may be less severe, but for the WHO chief “the narrative that it is mild disease is misleading, hurts the overall response and costs more lives.”

Tedros noted that the virus is circulating “far too intensely with many still vulnerable” and argued that, for many countries, the next few weeks remain critical.

COVAX

Over the weekend, the UN-backed COVAX facility delivered its one-billionth dose of vaccine. 

Tedros said he was proud of the milestone, but believes it’s essential to keep forging ahead with distributing shots fairly, across the world. 

“Vaccines may be less effective at preventing infection and transmission of Omicron than they were for previous variants, but they still are exceptionally good at preventing serious disease and death”, he explained. 

For him, immunization continues to be “key to protecting hospitals from becoming overwhelmed.”

Tracking the virus

The WHO chief also highlighted the importance of tracking new variants, like Omicron, in real time.

Tedros believes that the pandemic is “nowhere near over” and, with the incredible growth of Omicron, new variants are likely to emerge

So far, more than 7 million whole genome sequences from 180 countries have been submitted to GISAID, a global mechanism that provides open access to genomic data and was initially set up to track flu.

Using all that data, new formulations of vaccines are being developed and assessed for how they perform against different strains. 

Despite those efforts, Tedros is concerned that the world will enter “a second and even more destructive phase of vaccine inequity”, if it doesn’t change course. 

New treatments 

Last Friday, WHO recommended two new COVID-19 treatmentsto fight severe illness and death: a rheumatoid arthritis drug called baricitinib and a monoclonal antibody called sotrovimab.

For Tedros, the challenge, once again, is that high prices and limited supply means access is limited.

WHO is currently working with its partners in ACT-Accelerator to negotiate lower prices with manufacturers and ensure supply will be available for low- and middle-income countries.

Meeting

Next week, the WHO Executive Board, which is made up of 34 Member States, will meet to discuss the world’s health challenges.

The pandemic will remain at the forefront, but Member States will also be discussing the devastating impact of the pandemic on other health issues, and how the backsliding can be stopped. 

According to the WHO chief, the agency willbe working to accelerate progress on negotiations around a global pandemic accord.

Cervical Cancer Awareness

On a final note, Tedros noted that January is Cervical Cancer Awareness month.

In 2020, an estimated 604,000 women were diagnosed with cervical cancer worldwide and about 342, 000 women died from the disease.

The main cause of the disease is infection with high-risk types of human papillomavirus (HPV), an extremely common family of viruses that are transmitted through sexual contact.

There are, however, vaccines that protect against high-risk HPV types, which means it should be one of the most preventable and treatable forms of cancer.

On Monday, Serbia announced that this year,it will introduce a vaccination programme against HPV, joining the 116 nationswho already do it. 

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UN-backed COVAX mechanism delivers its 1 billionth COVID-19 vaccine dose

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photo © UNICEF/Aimable Twiringiyima

With a 1.1 million jab delivery in Rwanda this weekend, the World Health Organization’s multilateral initiative to provide equal access to vaccines for all reached the one billion milestone.

Along with the Coalition for Epidemic Preparedness Innovations (CEPI), the Vaccine Alliance GAVI, and partners, WHO has led the largest vaccine procurement and supply operation in history with deliveries to 144 countries to date.

According to a press release published on Sunday, as of 13 January 2022, out of 194 countries members of WHO, 36 have vaccinated less than 10% of their population, and 88 less than 40%.

COVAX’s ambition was compromised by hoarding/stockpiling in rich countries, catastrophic outbreaks leading to borders and supply being locked. And a lack of sharing of licenses, technology, and know-how by pharmaceutical companies meant manufacturing capacity went unused”, the agency explained.

On 24 February 2021, Ghana became the first country in the world to receive vaccines through COVAX when 600,000 doses of the Oxford–AstraZeneca vaccine were delivered to Accra. 

The work that remains

COVAX is currently working with governments, manufacturers and partners to ensure that when countries receive vaccines, they can get them to people quickly.

“The work that has gone into this (1 billion) milestone is only a reminder of the work that remains”, the UN’s health agency underscored.

They added that with updated vaccines in the pipeline, citizens should demand that governments and pharmaceutical companies share health tools globally and “bring an end to the death and destruction cycles of this pandemic, limit new variants and drive a global economic recovery”.

COVAX is one of three pillars of the Access to COVID-19 Tools (ACT) Accelerator, which was launched by WHO in April 2020 in response to the pandemic.

The ACT Accelerator is a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. 

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WHO recommends two new drugs to treat patients with COVID-19 

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Around two million doses of Sotrovimab are being produced globally in the first half of 2022. © GlaxoSmithKline

The World Health Organization (WHO) on Thursday reccommended two new drugs to treat patients with COVID-19, one for patients with critical disease, and another deemed effective for non-severe cases.

The first drug, baricitinib, is a Janus kinase (JAK) inhibitor- a class of drugs used to treat autoimmune conditions, blood and bone marrow cancers, and rheumatoid arthritis.

According to the WHO Guideline Development Group, it is “strongly recommended” for patients with severe or critical disease in combination with corticosteroids.

The group of international experts based their recommendation on “moderate certainty evidence” that it improves survival and reduces the need for ventilation.

There was no observed increase in adverse effects.

The experts note that it has a similar effectas other arthritis drugs called interleukin-6 (IL-6) inhibitors. Because of that, when both drugs are available, they suggest choosing the best option based on cost, availability, and clinician experience.

It is not recommended to use both drugs at the same time.

The experts also advise against the use of two other JAK inhibitors (ruxolitinib and tofacitinib) for patients with severe or critical cases of COVID-19 infection.

According to them, trials undergone using these drugs failed to show any benefits arising using either drug,and suggested a possible increase in serious side effects with tofacitinib.

Non-severe cases

In the same update, WHO makes a conditional recommendation for the use of a monoclonal antibody known as sotrovimab in patients with non-severe cases.

According to them, the drug should only be administered to patients at the highest risk of hospitalisation. In those at lower risk, it onlyshowed “trivial benefits”. 

A similar recommendation has been madepreviously, for another monoclonal antibody drug, casirivimab-imdevimab, and the experts say there is insufficient data to recommend one over the other.

For both, the effectiveness against new variants, like Omicron, is still uncertain. 

The group will update their guidelines for monoclonal antibodies when more data becomes available.

Recommendations

These recommendations are based on new evidence from seven trials involving over 4,000 patients with non-severe, severe, and critical infections.

Developed by WHO with the methodological support of MAGIC Evidence Ecosystem Foundation, the guidelinesprovide trustworthy guidance and help doctors make better decisions with their patients.

According to the agency, the guidelines are useful in fast moving research areas, because they allow researchers to update evidence summaries as new information becomes available.

The latest guidance also updates recommendations for the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19; conditional recommendations for the use of casirivimab-imdevimab (another monoclonal antibody treatment) in selected patients; and against the use of convalescent plasma, ivermectin and hydroxychloroquine, regardless of disease severity.

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