At a time when Europe’s beating cancer plan aims to include boys in HPV vaccination programs, vaccine shortages are creating a moral dilemma: Should a shot be given to a boy in the EU or a girl in a low-income country?
Today’s Brief comes between two events that both focus on cancer: We just stepped out of January, the cervical cancer month, and are heading for World Cancer Day on Friday (4 February).
And we chose indeed to talk about something that can prevent most cases of cervical cancer, as well as vaginal, vulvar, anal cancers, and mouth, throat, head and neck cancers in women and men. I’m sure many of you have guessed it right: it is about the Human papillomavirus (HPV) vaccination.
HPV vaccines have been available in the EU since 2006, and have become increasingly accessible over time in Europe and worldwide. “Globally, by 2020, about half of all countries have introduced HPV vaccination, covering about one-third of the eligible population of girls,” as it is stated in last month’s Eurosurveillance report.
In the meantime, all EU member states have introduced HPV vaccination to their national programs. “Yet, inequity and discrepancies persist in Europe,” Vaccines Europe, a specialised group of the EU’s pharma association EFPIA, warned in a statement.
The positive step pointed out in the Eurosurveillance report is that EU/EEA countries are moving towards a gender-neutral HPV vaccination strategy, instead of vaccinating only girls.
But nine EU member states have yet to include boys, Vaccines Europe pointed out.
The Eurosurveillance report highlighted reasons for including boys in HPV vaccination programs.
Firstly, “the indirect protection from vaccination of girls with suboptimal uptake” is not “sufficient to adequately protect males”.
Furthermore, men who have sex with men would be also protected. Finally, it is expected to be a more resilient strategy “against sudden drops in vaccine uptake” and would be more effective in reducing virus circulation in the general public.
But it seems that there might not be enough vaccines to ensure protection for both genders. Moreover, who will get the shot has become rather a moral dilemma.
Vaccine shortages = moral dilemma
Eurosurveillance reported that there is a “global shortage of HPV vaccines, which is mainly affecting girls in low- and middle-income countries (LMIC)”.
The World Health Organisation (WHO) foresees that the current shortage might last at least until 2024.
Extending HPV vaccination to boys implies a substantial increase in the number of doses to be procured and administered. Moreover, extending HPV vaccination to boys in EU/EEA countries might take away vaccines for girls vaccination in low-income countries.
“The average individual health benefit obtained from a dose of vaccine administered to a boy in the EU/EEA is substantially lower than the average individual health benefit obtained from a dose of HPV vaccine given to a girl in LMIC where cervical cancer screening is not implemented or well-established,” Eurosurveillance stated.
Therefore WHO’s Strategic Advisory Group of Experts (SAGE) on immunisation recently recommended “a temporary pause in the implementation of HPV vaccination of boys in those countries that are considering doing so”.
Moreover, it was recommended that “the vaccination of girls and boys older than 15 years and multi-age cohort vaccination strategies should temporarily pause”.
Asked about HPV vaccine shortages, the European Commission told EURACTIV that it has not been notified of such critical shortages of vaccines.
A Commission source added that the European Medicines Agency (EMA) and members of the EU single point of contact (SPOC) Network monitor and share information on shortages and availability issues of authorised medicines to coordinate actions to help prevent and manage shortages.
Shortages created by increase in demand
Sibilia Quilici, executive director of Vaccines Europe, told EURACTIV that COVID-19 did not create vaccine shortages. The main reason for HPV vaccination shortages is the sharp growth in demand.
“There has been a five-year period of stable demand with regards to HPV and, and suddenly, in 2018, the demand doubled,” Quilici said.
She added that vaccine manufacturers need to adjust their production because of the changes in demand and it takes time.
Quilici highlighted that “vaccines are one of the most complex biological products to produce and manufacture” and for HPV vaccines this process might take “up to four years from start to finish”.
This means that products we have in 2022 were planned back in 2018. “Basically, the quantity of products that are going out of the manufacturing side has been actually launched four years ago based on the demand for years ago,” Quilici said.
The WHO has set the plan to eliminate cervical cancer, followed by the goal of 90% of girls and increasing vaccination for boys by 2030 set in Europe’s Beating Cancer Plan launched by the Commission at the end of 2020.
Asked, when manufacturers might catch up with this increased demand for vaccines, Quilici said she cannot provide the date but she added that what is important is that targets set by both WHO and EU are needed indicators for manufacturers for planning their vaccine production.
“The programs give signals to the manufacturers as they need to be ready. So they will anticipate,” she said, adding that “if [manufacturers] don’t have signals they just basically cannot anticipate.”
(By Giedre Peseckyte)
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Ombudsman decision. The European Commission’s denial of access to text messages between Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla amounts to ‘maladministration’, the EU Ombudsman found. Ombudsman Emily O’Reilly, who made her verdict clear on Friday (28 January), stressed that the European Commission must “do a more extensive search for the relevant messages.”
HERA needs ‘democratic control’. European lawmakers must be both present and involved in the work of the newly established Health Emergency Preparedness and Response Authority (HERA), according to the body’s head Pierre Delsaux.
EMA repowering. The regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU on Monday (31 January). This officially concludes the legislative process for an important pillar of the European Health Union. The new regulation enters into force on the day following this publication and becomes applicable as of 1 March 2022, except for the provisions on shortages of critical medical devices which will apply as of 1 February 2023, as stated in the press release.
European hospital label. French Health Minister Olivier Véran detailed the key health priorities of the French EU Council presidency on Thursday (27 January), highlighting the launch of a new label called “European Hospital” to strengthen health systems and support cooperation across Europe. EURACTIV France reports.
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COVID waste. A report from World Health Organisation (WHO) found that COVID-19 response resulted in ‘tens of thousands of tonnes’ of additional medical waste, calling for better management of health care waste at all levels, from hospitals to landfills.
Omicron. The BA.2 subvariant of the Omicron coronavirus variant, which is dominant in Denmark, appears more contagious than the more common BA.1 sub-lineage, Danish Health Minister Magnus Heunicke said on Wednesday (26 January) in a national address.
Oral treatment. The European Medicines Agency (EMA) has recommended the conditional marketing authorisation of Pfizer’s new COVID antiviral drug Paxlovid, with the official authorisation by the European Commission expected imminently.
MEPs call for abortion to be included in the Charter of Fundamental Rights is supported by the French presidency, but according to an EU law expert, this is “not going to happen” – and having an anti-abortion Parliamentary president is not the only obstacle.
The new Clinical trial regulation (CTR) – which entered into force on 31 January – and the Accelerating clinical trials initiative (ACT EU) aim to gain back the EU’s position among clinical research leaders worldwide.
Blood and plasma
US plasma shortage. The US is facing its worst blood and plasma shortage in more than a decade due to a combination of the COVID pandemic and bad weather conditions, which stakeholders have warned could have ripple effects across the pond.
Blood optimal use. Health experts and European lawmakers suggest that new approaches to blood use could have ‘healing’ effects on the EU’s blood supply recently put under additional pressure due to the COVID pandemic.
Innovative Health Initiative
The €2.4 bn public-private partnership ‘Innovative Health Initiative’ (IHI), built on 14 years of experience from the previous ‘Innovative Medicines Initiative’(IMI), expands its scope, focusing less directly on pharmaceuticals and more broadly on health care.
On 26 January the first Antimicrobial resistance surveillance in Europe report was published. The report calls for robust investments in interventions to address AMR as they “would have a significant positive impact on population health and future healthcare expenditures in the region,” as is stated in the press release.
New treatment. On 28 January EMA has recommended granting a marketing authorisation in the EU for Breyanzi, a gene therapy for the treatment of adult patients with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, whose cancer has come back or who have not responded to treatment after two or more lines of systemic therapy.
More on HPV. A systematic review published by Eurosurveillance indicated that “absolute Risk of Guillain–Barré syndrome (GBS) after HPV vaccination is low”. From a public health point of view, up to one million people would need to be vaccinated to generate one additional case of GBS, as it is stated in the release.
Research published in Lancet found that Over 1.2 million additional opioid overdose deaths are expected in North America by 2029. The authors warn that the opioid epidemic will expand globally. Several countries outside North America targeted by the industry have already seen sharp increases in opioid prescribing, including the Netherlands, Iceland, England, Brazil, and Australia.
Access to medicines
Surveys carried out by consumer groups in 2019-20 in five European countries show that consumers face serious difficulties in getting some of the medicines they need, as is stated in The European Consumer organisation’s (BEUC) press release. BEUC has released a factsheet looking at what the most striking results from these five surveys show, and is calling on the EU to solve the problem of medicine shortages in its upcoming pharma legislation.
Overmedicalisation of death
According to a new Lancet Commission, published on Tuesday (1 February), today’s overemphasis on aggressive treatments to prolong life, vast global inequities in palliative care access, and high end-of-life medical costs have led millions of people to suffer unnecessarily at the end of life. The Commission calls for public attitudes to death and dying to be rebalanced, away from a narrow, medicalised approach towards a compassionate community model, where communities and families work with health and social care services to care for people dying.
Romania eases rules for people entering country. People arriving in Romania without a green pass or a negative PCR test will have to quarantine for only five days regardless of where they are coming from, according to new rules decided Monday. By Bogdan Neagu | EURACTIV.ro
Amnesty slams Spanish prosecution for ‘poor’ investigation of COVID-deaths in nursing homes. Amnesty International on Monday denounced the “poor performance” of the Spanish Public Prosecutor’s Office in clarifying over 35,000 deaths of elderly people in nursing homes during the peak of the COVID-19 outbreak in March-April 2020, EURACTIV’s partner EFE reports. By Fernando Heller | EuroEFE.EURACTIV.es
Italy continues mandatory face masks outdoor and closure for discos for ten days. The Italian government extended the use of compulsory face masks outdoors and the closure of clubs for ten days. According to a government source, Prime Minister Mario Draghi intends to keep restrictions to contain the spread of COVID-19 infections. By Eleonora Vasques | EURACTIV.com
Austria scraps lockdown for unvaccinated. Austria’s unvaccinated will no longer have to be in lockdown from Monday as COVID-19 vaccines will be made mandatory the following day on Tuesday, the government announced last week. By Nikolaus J. Kurmayer | EURACTIV.de
COVID-19 and jobs. The potential introduction of mandatory COVID-19 vaccines in Germany could have repercussions on the job market, as unvaccinated people would lose their claim to unemployment benefits and employers would be allowed to turn down applicants if they are not vaccinated. By Oliver Noyan | EURACTIV.de
German lawmakers split over mandatory vaccines. Lawmakers are divided beyond party divides following the Bundestag’s first debate about mandatory vaccines on Wednesday. By Julia Dahm | EURACTIV.de
ZAGREB | SARAJEVO
Croatia gives Mostar hospital €5.3 million to curb pandemic. Croatia will give the Mostar University Hospital in Bosnia and Herzegovina 40 million kuna or €5.3 million this year to help deal with the COVID-19 pandemic, the government decided on Thursday. By Zeljko Trkanjec | EURACTIV.hr
Protests in Warsaw as death toll related to Polish abortion ruling rises. Hundreds of people gathered on Wednesday evening at the Constitutional Tribunal and the headquarters of the ruling Law and Justice (PiS) party to protest against the Tribunal’s 2020 anti-abortion ruling after another woman died due to the doctors’ refusal to perform an abortion on time. By Aleksandra Krzysztoszek | EURACTIV.pl
2/4 February – Meeting of the Heads of Medicines Agencies (HMA) Network
3 February – Oslo Medicines Initiative 2022 webinar series – Non-financial incentives for stimulating affordable innovation
4 February – World Cancer Day
8 February – 10th ACCELERATE Paediatric Oncology Conference.
17-18 February – European Union/African Union summit