Virus World

PARIS, April 6 (Reuters) - France has launched a tender for 80 million doses of bird flu vaccines in order to be ready to start its vaccination programme in the autumn, it said on Thursday, the first member of the European Union to start such a scheme. The announcement came after French health and safety agency ANSES earlier on Thursday endorsed the government's plan to vaccinate millions of poultry birds against bird flu, setting out three scenarios for the campaign. Avian influenza, commonly called bird flu, has killed hundreds millions of birds around the world but governments have been reluctant to roll out vaccination programmes mainly because of the trade curbs these would entail. France - the worst affected European Union country last year, when it culled more than 20 million birds - said in December it aimed to start vaccinations this autumn. The pre-order, to be confirmed if final test results are positive, is to vaccinate ducks only, a spokesperson at the French agriculture ministry said. Ducks are very receptive to the virus and remain asymptomatic for many days, increasing the risk of transmission.

France has mandated two companies, France's Ceva Animal Health and Germany's Boehringher Ingelheim to develop bird flu vaccines for ducks. Ceva said initial results were "very promising", notably by sharply reducing the excretion of the virus by infected birds. ANSES, which the ministry had tasked with presenting a range of vaccination strategies, reported back with three scenarios on Thursday. The most limited plan would involve vaccinating all breeding poultry birds, which would entail millions of doses. A second option to be applied simultaneously or at a later stage, adds foie gras ducks, free-range turkeys and ducks and future free-range layer pullets; and a third all layer hens and web-footed poultry not already covered elsewhere. None of the scenarios involves vaccinating broilers which account for the majority of France's poultry, considered at relatively low risk of catching the virus. The government tends to at least partly follow ANSES recommendations. "In view of the particularly worrying epidemiological context... the agency stresses the importance of implementing the broadest possible vaccination strategy, provided the means are available," the agency advised. ANSES also stressed the capacity for the virus to jump across species barriers, posing a potential risk to human health. Bird flu is transmitted by infected faeces from migrating wild birds or direct contact with contaminated feed, clothing and equipment, or through the air.

Reporting by Sybille de La Hamaide; editing by John Stonestreet and Susan Fenton

France on Friday said under 55s who received a first injection of the AstraZeneca Covid-19 vaccine should be given a jab from a different producer for their second dose, a ruling affecting more than 500,000 people. France's national health authority HAS last month said the AstraZeneca vaccine should only be given to those aged 55 and over because of reports of potentially deadly blood clots in a very small number of those younger people vaccinated. Officials in France initially said that those given the AstraZeneca jab in a first dose should go ahead with the second jab even if aged under 55. But the HAS said that those aged under 55 who had been given the AstraZeneca as their first dose would now get the Pfizer-BioNTech or Moderna vaccine as their second course. France has been injecting health workers as a priority group meaning that many younger people have already received the AstraZeneca jab. Some 533,000 people are affected by the decision, the HAS said.  They include Health Minister Olivier Véran, a neurologist aged 41, who was given the AstraZeneca vaccine live on television on February 8. "It is completely consistent to say that we do not recommend the AstraZeneca vaccine to people under 55 years of age while we learn more," the minister told RTL. "Therefore, if you have received a first injection and are under 55 years old, you will be offered another vaccine 12 weeks after the first injection."

'Records to be broken'

Europe's medicines regulator said this week the AstraZeneca vaccine could cause very rare blood clots among some recipients, prompting several countries to scale up restrictions on the jab. Several clinical trials are looking at the efficacy of combining two types of vaccine. "Based on previous studies which combine different vaccine types, a combination of the AZ and Pfizer vaccines is likely to be safe but it's important that this is tested in the context of a clinical vaccine trial," said Helen Fletcher, professor of Immunology at the London School of Hygiene and Tropical Medicine. The WHO currently recommends the same product be used for both doses but has said further research should be carried out on the interchangeability of vaccines in so-called "mix and match" strategies.  After a sluggish start, France's vaccine campaign is now gaining pace and Prime Minister Jean Castex said Thursday over 10 million people in the country had now received at least their first dose. Veran said a record 437,000 people had been injected in France on Thursday alone. "Records are made to be broken and we will go beyond that in the next days," he said.

Doctors in France are treating a critically ill patient infected with the South African coronavirus variant, four months after he recovered from COVID-19, in what study authors said was the first case of its kind.  The 58-year-old man had a history of asthma and initially tested positive for COVID-19 in September when he presented to medical staff with a fever and shortness of breath. The symptoms persisted only for a few days, and the man tested negative for COVID-19 twice in December 2020. However, he was admitted to hospital in January and diagnosed with the South African variant. The patient's condition worsened, and he is currently in a "critical condition" on a ventilator. 

"This is, to our knowledge, the first description of reinfection with the South African (variant) causing severe COVID-19, four months after a first mild infection," said authors of a study published this week in the journal Clinical Infectious Diseases. The 501Y.V2 coronavirus variant emerged late last year in South Africa and immediately provoked alarm among disease specialists. It has eight key mutations, one of which affects the virus' spike protein, making it more effective at binding to human cells and therefore more infectious. Vaccine manufacturers Pfizer/BioNTech and Moderna say their mRNA vaccines retain their effectiveness against the South African variants and another that emerged last year in Britain. However a study last week showed that AstraZeneca's vaccine failed to prevent mild and moderate cases of infection of the South African variant. "The impact of 501Y.V2 mutations on the effectiveness of vaccines developed based on earlier SARS-CoV-2 strains is still unknown," said the authors of the reinfection study.

Case study published in Clinical Infectious Diseases (Feb. 10, 2021):

https://doi.org/10.1093/cid/ciab129

The World Health Organization (WHO) has warned that coronavirus cases are surging alarmingly in Europe, as a "very serious situation" unfolds across the continent. As Covid-19 infections spike to record numbers, European governments are imposing strict local measures and weighing up further lockdowns in a bid to halt a second wave of the pandemic. But WHO regional director Hans Kluge said at a Thursday news conference that the increase in cases should serve as a warning of what is to come. "Weekly cases have now exceeded those reported when the pandemic first peaked in Europe in March," Kluge said. "Last week, the region's weekly tally exceeded 300,000 patients."

Below are excerpts from an interview with Dr. Didier Raoult, who published the first report of a small clinical trial with results showing clinical benefit of a combination therapy of hydroxychloroquine together with azithromycin.

...Despite the echo given to the political and medical distrust regarding his clinical trial, the head of the IHU is convinced of the relevance of hydroxychloroquine to treat patients with Covid-19. Despite the media psychosis and his daily death toll, he repeats: we are more likely to die from something other than "Chinese coronavirus". 

24 patients are followed in the clinical trial, how many people have been treated since ...
Pr Didier Raoult:  We have treated others, but I won't tell you how many. I will first notify the department.

After six days of treatment, the viral load of 75% of the patients is negative, are they cured?

Pr Didier Raoult:  They are cured of the virus. But if you have lung damage, it won't go away in three days. We also don't know at the moment whether  if once cured, you can fall ill again, this has not been described by the Chinese who are two months ahead of us.

What about the 25% who are still positive? Does their situation worsen as we say around the 7th and 8th days?

Pr Didier Raoult:  We have not had any aggravation in the cases treated but we do not see people in serious condition. For the moment, serious cases are those that are neither detected nor treated and arrive with very serious respiratory failure. They go straight to resuscitation and they will die there. If we screen and treat people early, there is  a better chance of saving them than if we treat them 48 hours before the terminal phase.

Your strategy since the beginning of the epidemic is to mobilize all the IHU to make massive screening, why, it was not a national strategy from the beginning?

Pr Didier Raoult:  It's not my strategy, it's common sense. I do not know why it is not a national strategy, it is a political choice. Me, I do my duty, period. I do what I have to do, I play my score in a room. But I I who invented the theater, nor the text. I am the only one with a classic thought on infectious diseases when everyone is losing their nerves ...

What about the side effects of treatment with hydroxychloroquine?

Pr Didier Raoult:  What people say about side effects is simply delusional. These are people who haven't opened a medical book in years. Over a billion people have taken it, people who suffer from lupus take it for decades ... I know these drugs very well, I have treated 4,000 people with Plaqenil for 20 years. It's not me who's weird, it's people who are ignorant. I'm not going to be told the toxicity of this drug.

(Translated from French)

Jab does not offer complete protection against illness but usually prevents infection. French health authorities have launched an investigation after 59 per cent of people in a new mpox cluster said they were fully vaccinated. Vaccination does not offer complete protection against the virus – though only one in four French cases are usually in immunised people. Mpox, formerly known as monkeypox, can cause and unusual spots, ulcers or blisters anywhere on the body; fever; headaches; muscle aches; chills; fatigue and swollen glands. Though most people have a mild illness, with recovery within three weeks, some cases can cause severe illness and occasionally result in death. Mpox is not normally a sexually-transmitted infection, but it can be passed on by direct contact during sex. The cluster in France’s Centre-Val de Loire comes despite the region having a high vaccination rate, with experts warning of a potential mutation in the virus.

The mpox vaccine is not tailored to the disease and was originally created to protect against smallpox. Last year, the UK Health Security Agency (UKHSA) recommended offering Imvanex to those at increased risk of exposure to the virus. Dr Michael Marks, Associate Professor at the London School of Hygiene and Tropical Medicine, told the Telegraph that health authorities may need to investigate whether a mutation has affected the vaccine’s efficacy. He also noted that many mpox cases have been reported in people with HIV. “HIV may modify how effective the vaccine is. We don’t know the HIV status of this cluster at the moment.”

France’s public health body, Sante Publique France, have said they are investigating the cluster and are waiting for “robust data” on the efficacy of the vaccine. Mpox can also be spread through touching clothing, bedding or towels used by someone with the mpox rash, and through the coughs and sneezes of somebody with the infection. An outbreak of the disease in London and other British cities made headlines last year – though infections have slowed following a targeted vaccination programme. The outbreaks raised alarm because the viral disease, which spreads through close contact and was first found in monkeys, mostly occurs in west and central Africa and only occasionally spreads elsewhere. Over 25,800 cases have been reported in Europe since spring 2022, mostly among men who have sex with men.

The French company said its vaccine generated a stronger immune response than the Oxford/AstraZeneca vaccine.  Based on a U.K. trial of 4,012 participants, Valneva said that its vaccine stimulated the creation of protective antibodies at around a 40 percent higher rate compared with AstraZeneca’s vaccine and was better tolerated. The vaccine also prevented coronavirus infections at a similar rate to the Oxford/AstraZeneca shot, and there were no serious cases across both groups, the company said. A placebo-controlled trial was not possible on ethical grounds, given the arrival of authorized vaccines.  Chief Medical Officer Juan Carlos Jaramillo told journalists in a briefing that Valneva is positioning the jab as a first-vaccination course for people in the U.K., Europe, North America and around the world. “I think there's very much a role for this vaccine, even in places where the programs are well advanced,” added Adam Finn, chief investigator. The biotech began a rolling review in August with the U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) and plans to finalize its submission in November. It expects an initial approval, “hopefully by the year-end,” Jaramillo said. A European decision is anticipated early next year. This will initially be for those aged 18 to 55, based on the trial participants. The company anticipates expanding its use to older and younger people based on ongoing trials. Valneva is also carrying out a booster study with its inactivated virus vaccine. Investors reacted positively to Valneva's announcement, sending its shares 36% higher in European trading.

Bittersweet pill

While it’s positive news for the French company, which chose the U.K. for its clinical development as well as for manufacturing its vaccine, it’s tainted by a lack of buyers.  Britain last month terminated its contract to buy 190 million doses; the first 60 million doses were expected in the first quarter of 2022. The U.K. alleged that Valneva was in breach of its obligations under the supply agreement, which the company said it strenuously denied. A Department of Health and Social Care spokesperson said on Monday in an emailed statement that they had "received the latest interim clinical trial data,” but did not address whether the contract was still salvageable. Meanwhile, the company has been in prolonged talks with the European Commission but has not completed an agreement due to issues over agreeing to a supply schedule. Jaramillo said he was unable to comment on the U.K.’s contract but said EU discussions “are happening as we speak.” Meanwhile, MHRA approval could pave the way for World Health Organization pre-qualification, Finn pointed out. Valneva is preparing to submit a rolling review with the European Medicines Agency and anticipates a decision in the first quarter of 2022.

Promising data

The Valneva shot is the only vaccine in clinical development in Europe based on a whole inactivated, adjuvanted virus — a more traditional form of vaccine than mRNA or adenoviral-vector shots. Similar technology is used in the Chinese vaccines from Sinopharm and Sinovac. In terms of safety, Valneva said that participants who received its vaccine reported “significantly fewer” adverse side-effects when compared with Oxford/AstraZeneca. In addition, analysis shows that the shot provoked the creation of a broad spectrum of T-cells, which, along with antibodies, give protection against the coronavirus and are understood to be linked with long-term immunity. Given that the vaccine contains the whole inactivated virus, T-cell immune responses were detected not only against the S (spike) protein but also against other parts of the virus known as M and N proteins. To date, all EU authorized vaccines only target the spike protein. This broader approach “theoretically provide[s] you with some security if you like against viral evolution,” said Finn.

Valneva's Press Release (Oct. 18, 2021):

https://valneva.com/press-release/valneva-reports-positive-phase-3-results-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/ 

The French capital and various other areas will have movement restricted as cases rise.  Some 21 million people in 16 areas of France will be placed under the measures from midnight on Friday. These measures will not be as strict as the previous lockdown, Prime Minister Jean Castex said, with people allowed to exercise outdoors. France has recorded more than 35,000 new infections within the past 24 hours. Mr Castex said a "third wave" of infections in the country was looking increasingly likely. The situation in Paris is particularly worrying with 1,200 people in intensive care there, more than at the peak of the second wave in November, Health Minister Olivier Véran said. Under the new measures, non-essential businesses will be forced to close, but schools will remain open, along with hairdressers if they follow a "particular sanitary protocol". Government spokesman Gabriel Attal stressed there would be differences with the two earlier lockdowns and said further details would be given of which business could stay open or would have to shut. People will be allowed to exercise outdoors within 10km (6 miles) of their home and are not allowed to travel to other parts of the country unless they have a valid reason. Those in the affected areas will have to fill out a form to explain why they have left their homes.

PARIS (AP) — France will only administer the AstraZeneca coronavirus vaccine to people under age 65, President Emmanuel Macron said Tuesday after the government's health advisory body cited a lack of sufficient data about its effectiveness in older people.  The decision could shake up the French vaccination strategy, because the country has prioritized nursing home residents and people over 75. France had counted on the AstraZeneca vaccine for a large part of its upcoming inoculations, until the company announced delays affecting countries around Europe and the world. “For this AstraZeneca vaccine, we will not propose it to those older than 65,” Macron told TF1 television Tuesday night. Instead, the vaccine the British-Swedish company developed with Oxford University will be given to medical personnel under 65, individuals with health vulnerabilities or those facing high exposure, he said.  The French practice differs from the guidance given by the European Medicines Agency, which authorized AstraZeneca’s vaccine for use in all adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population. Health authorities in Germany and other countries have raised concerns that the Anglo-Swedish company didn’t test the vaccine in enough older people to prove it works for them, and indicated they would not recommend it for people over 65. In guidance issued Tuesday, France’s High Authority for Health said it “recommends that the vaccine ... be given preferentially to people under 65.” It says it will review this guidance when AstraZeneca has more data on the vaccine’s effectiveness in older people.

The French government depends on the High Authority’s guidance and is adapting its strategy based on the announcement. Health officials have said they constantly adapt vaccine strategy based on availability of doses, demand and regulatory guidance. Macron said France still aims to offer the vaccine to anyone who wants it by the end of the summer.  Macron met Tuesday night with international vaccine producers and major pharmaceutical companies that have an industrial site in France to discuss ways to “quickly” and “significantly” boost short-term production capabilities in France and in Europe. The meeting came amid criticism of the EU’s handling of its collective vaccine strategy across the bloc’s 27 member nations. Macron said he sent a scientific team to Russia several weeks ago to study that country’s vaccine efforts and “the exchanges were very positive.” The French leader noted early results of an advanced study of Russia’s Sputnik V published in The Lancet medical journal that showed the vaccine was about 91% effective.  Macron said that if and when the European Medicines Agency decides approve the Russian vaccine, it will not be a “political decision. It’s a decision that is scientific.” France has seen some of the world’s highest numbers of confirmed virus cases and deaths, which have been steadily rising in recent weeks.

The new rule comes as France starts lifting its coronavirus lockdown on Monday. It has reignited a debate over a 2010 ban on religious face coverings. From Monday, all people in France must now wear a face mask in public to avoid further spread of the COVID-19 disease. However, the burqa, niqab, and other religious face and head coverings remain banned — reigniting a debate over the government's 2010 ban on religious coverings.

France mandated face masks in public to coincide with a gradual easing of its strict coronavirus lockdown, which started Monday. Under these new rules, people can now travel 60 miles from home, and some businesses and schools can reopen. However, bars and restaurants — which have been closed on March 17 — remain shuttered. Those using public transport, entering certain shops, or attending schools must now wear a mask, the government said. The issue of face coverings is especially sensitive in France, and has been a major political issue on at least two occasions since the new millennium. In 2010, the government imposed a ban on Muslim head coverings, namely the burqa or niqab. Those in favor of the bill protected gender equality and women's dignity, and encouraged assimilation into secular French culture. Critics saw it as an attack on religious freedom. 

Flouting the law can result in a 150-euro ($162) fine and/or participation in so-called French citizenship education.  When asked whether the new coronavirus face mask regulations affected the 2010 law, France's interior ministry told The Washington Post: "Wearing a mask intended to prevent any risk of contagion by COVID-19 does not constitute a criminal offense."...