Elle accueille le plus important des trois centres de fabrication du vaccin Pfizer-BioNtech en Allemagne, qui doit produire 250 millions de doses au cours du premier semestre, 750 millions d’ici à un an.

De grandes tentes en plastique sur un vaste parking à moitié vide. En ce mercredi de mars, il n’y a pas foule devant le centre de vaccination de Marburg. Environ 700 personnes auront reçu une injection ce jour-là. « Quand il y aura assez de vaccins, on pourra accueillir jusqu’à 1 260 personnes par jour », explique un responsable.

A 4 kilomètres de là, au détour d’une petite route de campagne. Des grilles. Des vigiles. Pas question d’entrer. Pas moyen non plus d’engager la discussion avec ceux qui travaillent ici, auxquels la consigne a été donnée de ne pas parler à la presse. Ce que renferme ce lieu si secret ? Le plus important des trois centres de fabrication du vaccin Pfizer-BioNTech en Allemagne. Entré en service mi-février, il doit produire 250 millions de doses au cours du premier semestre, 750 millions d’ici à un an.

Par Thomas Wieder / Le Monde

L’article En Allemagne, comment Marburg est devenue « BioNTech City » est apparu en premier sur زوايا ميادين | Mayadin Columns.

The analysis by the Food and Drug Administration’s (FDA) means it could become the second coronavirus vaccine to be allowed in the US.

It comes one day after Americans across the country began receiving jabs of the Pfizer-BioNTech vaccine.

The news comes as the US coronavirus death toll passes 300,000, according to Johns Hopkins University.

Endorsement of the Moderna vaccine by FDA scientists was announced on Tuesday, two days before the vaccine panel meets to discuss emergency approval.

What were their findings?

The 54-page document said there were “no specific safety concerns” and that serious adverse reactions were rare.

If approved by the team of experts later this week, and by the FDA’s vaccine chief, shipments could begin within 24 hours.

The FDA found a 94.1% efficacy rate out of a trial of 30,000 people, according to the document they released.

The most common side effects included fever, headaches, and muscle and joint pain.

Last week, the FDA released similar data from Pfizer before voting to issue approval.

Moderna was founded in 2010 and so far has never had a product approved by the FDA.

The company’s stocks have seen a nearly 700% increase so far this year.

How does it differ from the Pfizer jab?

The Moderna vaccine requires temperatures of around -20C for shipping – similar to a regular freezer.

The Pfizer jab requires temperatures closer to -75C, making transport logistics much more difficult.

Like the Pfizer jab, the Moderna vaccine also requires a second booster shot. Moderna’s second jab comes 28 days after the first.

The company is based in Cambridge, Massachusetts, and has said that if approved, the “vast majority” of its vaccine would be manufactured there.

Pfizer’s drug is being manufactured in several countries, including Germany and Belgium.

World Opinions News – bbc.com

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The results are in for a forerunner in the race for a COVID-19 vaccine.

United States pharma giant Pfizer Inc and its German partner BioNTech said on Wednesday that final results from the Phase 3 trial of their COVID-19 vaccine showed it to be 95 percent effective – the highest success rate for any pandemic candidate in late-stage trials so far.

The drug companies will now submit an application with the US Food and Drug Administration for Emergency Use Authorization (EUA) “within days” and to share trial data with other regulatory agencies around the globe, said Pfizer.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer chief Albert Bourla in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Before the FDA authorises any COVID-19 vaccine for emergency use, officials will review and discuss the trial data in a public meeting likely to take place next month, said Pfizer.

Pfizer and BioNTech expect to produce up to 50 million vaccine doses globally this year and as many as 1.3 billion doses by the end of 2021.

If the FDA grants emergency use, it will still be months before the vaccine is widely available. Governments though are expected to give priority to groups such as front-line healthcare workers and immunocompromised individuals to receive the vaccine this year.

The Pfizer-BioNTech late-stage trial involved nearly 44,000 volunteers, of which 42 percent globally and 30 percent in the US had diverse backgrounds.

The results showed the vaccine to be consistently effective across people of different ages, races and ethnicities. For people above 65, the vaccine was shown to be 94 percent effective, said Pfizer.

Some 170 infections were observed in the study, eight of which were observed in people who received the vaccine rather than a placebo. One of those eight who received the vaccine developed a severe case of COVID-19.

The trial will continue to collect data on efficacy and safety for two more years.

Wednesday’s announcement comes a week after initial results from the trial showed the vaccine was more than 90 percent effective and days after Moderna Inc released promising preliminary trial data for its COVID-19 vaccine that showed it be 94.5 percent effective.

Neither Pfizer-BioNTech nor Moderna’s vaccines are made with the coronavirus. Instead, they were developed with new messenger RNA (mRNA) technology that relays genetic instructions to teach the human immune system – how to make virus-slaying antibodies.

Logistical concerns have been raised about distribution of the Pfizer-BioNTech vaccine because it needs to be stored in ultracold temperatures of -70 degrees Celcius (-94 degrees Fahrenheit).

The companies sought to assuage those concerns, saying they have developed speciality temperature-controlled thermal shippers that can be used as temporary storage units for 15 days by refilling them with dry ice.

“We have confidence in our vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world,” said Pfizer.

The better than expected results from late-stage trials of Pfizer-BioNTech’s vaccine as well as Moderna’s have ignited hopes that a gamechanger is within grasp to conquer a pandemic that has claimed more than 1.3 million lives around the world, decimated the global economy, obliterated livelihoods, and exacerbated inequalities between and within nations.

Pfizer’s final results come as new infections are raging across the world, with surges of new cases straining healthcare systems that are dealing with record spikes in hospitalisations.PUBLICITÉ

Dozens of drug companies and research groups are working to develop a safe and effective vaccine against COVID-19.

SOURCE : AL JAZEERA

L’article Pfizer ends COVID-19 vaccine trial with 95% success rate est apparu en premier sur زوايا ميادين | Mayadin Columns.

Le chef de l’Organisation mondiale de la santé (OMS) a salué ce lundi des “nouvelles encourageantes” sur le front des vaccins. Moderna a en effet annoncé, dans la journée, une efficacité de son vaccin contre le Covid-19 de l’ordre de 94,5%. Un record jusqu’ici, alors que Pfizer/BioNTech tablait sur une efficacité de 90%, contre 92% pour Spoutnik-V, le sérum russe. Tedros Adhanom Ghebreyesus a cependant souligné que “l’heure n’est pas à la complaisance”.

“C’est un virus dangereux, qui peut attaquer tous les systèmes du corps. Les pays qui laissent le virus circuler librement jouent avec le feu”, a rappelé le directeur général de l’OMS, lors d’une conférence de presse. “Nous continuons à recevoir des nouvelles encourageantes sur les vaccins et restons prudemment optimistes quant à la possibilité que de nouveaux outils commencent à arriver dans les prochains mois”, a-t-il dit.

L’UE approuve un contrat de vaccin avec CureVac

La Commission européenne a annoncé ce lundi avoir approuvé un nouveau contrat de vaccin contre la Covid-19, le cinquième de ce type, avec le groupe pharmaceutique allemand CureVac, pour 405 millions de doses, et espère en signer un sixième “bientôt” avec l’américain Moderna. 

Bruxelles avait annoncé mercredi un contrat avec l’américain Pfizer et l’allemand BioNTech prévoyant “jusqu’à 300 millions de doses” achetées. Trois autres contrats ont été conclus avec AstraZeneca, Johnson & Johnson (400 millions de doses chacun) et le duo le duo franco-britannique Sanofi-GSK (jusqu’à 300 millions de doses). 

De nouvelles restrictions aux Etats-Unis

Face à la flambée de nouveaux cas aux Etats-Unis, États et métropoles ont réintroduit des restrictions ces derniers jours. Le nombre de cas recensés aux Etats-Unis dépasse désormais les 11 millions, avec plus de 246 000 morts depuis le début de la pandémie. 

A l’approche de la fête de Thanksgiving, le 26 novembre, habituellement occasion de grandes réunions familiales, une série de mesures ont été annoncées, très variables selon les Etats, sans aller jusqu’au confinement sauf au Nouveau-Mexique, où la gouverneure démocrate Michelle Grisham a instauré un ordre de confinement pour deux semaines. A New York, où le taux de positivité des tests reste inférieur à 3%, le gouverneur Andrew Cuomo a imposé depuis vendredi un couvre-feu aux bars et restaurants, qui doivent fermer à 22h00.  

Différence notoire par rapport au printemps : une majorité d’Etats – 31 sur 50, dont des Etats aux gouverneurs républicains généralement plus hostiles aux restrictions que les démocrates – imposent désormais le port du masque. Y compris le très rural Dakota du Nord, où le républicain Doug Burgum a imposé la mesure samedi après s’y être longtemps refusé.  

World Opinions News – AFP

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« L’efficacité du vaccin développé par Pfizer-BioNTech contre le COVID-19 est une bonne nouvelle. Cependant, il est préoccupant que savoir que Pfizer-BioNTech a déjà passé des accords avec les pays riches pour plus d’un milliard de doses de ce vaccin, et qu’il ne reste donc plus qu’un quart de son approvisionnement prévisionnel pour le reste du monde. Ce type d’accord bilatéral risque de saper les éventuels bénéfices de découvertes scientifiques ; l’enrichissement de Big Pharma ne doit pas passer avant la santé de milliards de personnes.

« Pfizer-BioNTech doit de toute urgence indiquer clairement comment il va procéder pour maximiser l’accès à son vaccin pour les pays à faible revenu ou à revenu intermédiaire afin des sauver des vies. Ce laboratoire doit également partager sa technologie concernant le vaccin avec d’autres fabricants au moyen du Groupement d’accès aux technologies contre la COVID-19 (ou C-TAP) créé par l’OMS, afin que les milliards de vaccins nécessaires soient produits aussi rapidement et à bon marché que possible. La pandémie ne sera pas terminée tant qu’elle n’aura pas pris fin pour toutes les personnes. »

Contexte

Pfizer-BioNTech a d’ores et déjà passé un accord pour la fourniture de plus d’un milliard de doses potentielles de son vaccin, y compris avec une première livraison de 100 millions de doses aux États-Unis, de 30 millions de doses au Royaume-Uni, de 120 millions de doses au Japon, de 20 millions de doses au Canada, de 1,5 million de doses à la Nouvelle-Zélande, et de 200 millions de doses à l’Union européenne (UE). Il a également passé un accord pour la fourniture de 500 millions de doses supplémentaires avec les États-Unis et de 100 millions de doses supplémentaires avec l’UE.

Compte tenu du fait que l’entreprise prévoit de fabriquer 50 millions de doses en 2020 et 1,3 milliard de doses 2021, il ne reste plus qu’une petite partie de ces doses potentielles pour les autres pays. Deux doses de ce vaccin seraient nécessaires pour protéger une personne contre le COVID-19.

L’Organisation mondiale de la santé a mis en place le Groupement d’accès aux technologies contre la COVID-19, ou C-TAP, un système permettant aux entreprises pharmaceutiques de partager volontairement leur technologie, les données et les droits liés à la propriété industrielle pour les vaccins contre le COVID-19. Jusqu’à présent, aucune entreprise n’a participé à cette plateforme, et le PDG de Pfizer l’a qualifiée d’« absurdité » au moment de son lancement, en mai.

World Opinions Freedom – amnesty.org

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The developers – Pfizer and BioNTech – described it as a “great day for science and humanity”.

Their vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised.

The companies plan to apply for emergency approval to use the vaccine by the end of the month.

No vaccine has gone from the drawing board to being proven highly effective in such a short period of time.

There are still huge challenges ahead, but the announcement has been warmly welcomed with scientists describing themselves smiling “ear to ear” and some suggesting life could be back to normal by spring.

“I am probably the first guy to say that, but I will say that with some confidence,” said Sir John Bell, regius professor of medicine at Oxford University.

How effective could it be?

A vaccine – alongside better treatments – is seen as the best way of getting out of the restrictions that have been imposed on all our lives.

The data shows that two doses, three weeks apart, are needed. The trials – in US, Germany, Brazil, Argentina, South Africa and Turkey – show 90% protection is achieved seven days after the second dose.

However, the data presented is not the final analysis as it is based on only the first 94 volunteers to develop Covid so the precise effectiveness of the vaccine may change when the full results are analysed.

Dr Albert Bourla, the chairman of Pfizer, said: “We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”

Prof Ugur Sahin, one of the founders of BioNTech, described the results as a “milestone”.

When will the vaccine be available?

A limited number of people may get the vaccine this year.

Pfizer and BioNTech say they will have enough safety data by the third week of November to take their vaccine to regulators.

Until it has been approved it will not be possible for countries to begin their vaccination campaigns.

The two companies say they will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. Each person needs two doses.

The UK should get 10 million doses by the end of the year, with a further 30 million doses already ordered.

Who would get it?

Not everyone will get the vaccine straight away and countries are each deciding who should be prioritised.

Hospital staff and care home workers will be near the top of every list because of the vulnerable people they work with, as will the elderly who are most at risk of severe disease.

The UK is likely to prioritise older resident in care homes and the people that work there.

But it says a final decision has not been made, saying it will depend on how well the vaccine works in different age-groups and how the virus is spreading.

People under 50 and with no medical problems are likely to be last in the queue.

Are there any potential problems?

There are still many unanswered questions as this is only interim data.

We do not know if the vaccine stops you spreading the virus or just from developing symptoms. Or if it works equally well in high-risk elderly people.

The biggest question – how long does immunity last – will take months or potentially years to answer.

There are also massive manufacturing and logistical challenges in immunising huge numbers of people, as the vaccine has to be kept in ultra-cold storage at below minus 80C.

The vaccine appears safe from the large trials so far but nothing, including paracetamol, is 100% safe.

How does it work?

There are around a dozen vaccines in the final stages of testing – known as a phase 3 trial – but this is the first to show any results.

It uses a completely experimental approach – that involves injecting part of the virus’s genetic code – in order to train the immune system.

Previous trials have shown the vaccine trains the body to make both antibodies – and another part of the immune system called T-cells to fight the coronavirus.

What has the reaction been?

The UK’s chief medical advisor Prof Chris Whitty said the results showed the “power of science” and was a “reason for optimism” for 2021.

Preliminary news that the Pfizer/BioNTech vaccine is effective demonstrates the power of science against COVID. We must see the final safety and efficacy data, but it is very encouraging.

It is essential we continue to suppress COVID, but it is a reason for optimism for 2021.

— Professor Chris Whitty (@CMO_England) November 9, 2020

The US president-elect Joe Biden said it was “excellent news”.

“It is also important to understand that the end of the battle against Covid-19 is still months away,” he added.

The UK Prime Minister’s official spokesman said the results were “promising” and that “the NHS stands ready to begin a vaccination programme for those most at risk once a Covid-19 vaccine is available”.

Prof Peter Horby, from the University of Oxford, said: “This news made me smile from ear to ear.

“It is a relief… there is a long long way to go before vaccines will start to make a real difference, but this feels to me like a watershed moment.”

World Opinions News – bbc.com

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