Tag: Biontech

EU regulator authorises Moderna Covid-19 vaccine

EU regulator authorises Moderna Covid-19 vaccine

Moderna Covid-19 vaccine: On Wednesday, European Union regulator authorised the use of Moderna Covid-19 vaccine for the bloc. It is the second vaccine approved by the 27-member Union. The decision came amidst the rising criticism regarding slow pace of vaccination, which was required to shield 450 million population of the region. The announcement was made after European Medicines Agency gave a go ahead to the Moderna vaccine with an aim to increase number of vaccination doses available for the bloc.

European Commission President Ursula von der Leyen said, “We are providing more COVID-19 vaccines for Europeans. With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will come.”

“This vaccine provides us with another tool to overcome the current emergency,” said EMA Executive Director Emer Cooke. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

Last month, EU provided similar authorisation to US vaccine developer Pfizer and Germany’s BioNTech. In case of both the vaccines, people are required to take two shots at the gap of about two-three weeks. As per the existing deal with Pfizer-BioNTech, EU would be purchasing 300 million doses. But with the current approvals granted to Moderna, EU would avail 80 million more doses, with an option to further extend the order to 80 million extra doses. Besides, Moderna gained an upper hand over rest of the vaccines as it is easier to handle, transport and did require ultra-frozen temperatures for the storage.

Both Moderna and Pfizer-BioNTech have been labelled safe to use as they both employ mRNA vaccine technology, which imply that the vaccine doesn’t contain any coronavirus. Instead, the medicine uses a certain type of genetic code which signals the immune system when it contacts a spike protein on the surface of the virus, about to attack.

Welcoming the move, Commissioner for Health and Food Safety Stella Kyriakides said that the vaccine authorization “will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come. Member States have to ensure that the pace of vaccinations follows suit.”

Austrian Chancellor Sebastian Kurz also commended the decision and wrote on Twitter that approval of the Moderna vaccine “is another important step in the fight against the pandemic. This means we have more vaccine available in the EU and can fight the pandemic faster.”

Moderna said that it was working towards producing about 500 to 600 million doses in 2021 to meet the global demand. On Monday, the pharmaceutical company said it is “continuing to invest and add staff to build up to potentially 1 billion doses for 2021.”

Covid-19 vaccine, between geopolitics and science

Covid-19 vaccine, between geopolitics and science

Geopolitics and Science: The disastrous 2020 is about to end. Among the wishes for the new year, also the anticipation for the vaccine to be received for all. December 8, 2020, will be remembered as the day 90-year-old Margaret Keenan was the first person in England to receive an mRNA vaccine outside of a clinical trial. But the historical moment we are about to live in is full of dark questions that have little to do with science. So, what story should we prepare to tell the new-born from next year? The story of the Covid-19 pandemic has unveiled issues never dormant in human history.

While the now ex-US President Donald Trump was trying to grab European companies at the forefront in the field of vaccines, other nations proceeded to vaccinate essential people in this war on the virus, like hospital staff, police, public transport drivers at home. We remember that Europe has always been and still is at the forefront in this sector worldwide. According to several reports, China had already started in spring 2019 with its self-sufficient vaccines. Also, Russia has already begun using its Sputnik V for some time and is now proceeding with mass vaccination. In the West, things follow different paths. There are precise rules agreed internationally in Europe and the USA that observe this way.

The European Commission still underlines that vaccines are the best opportunity we have to end the Covid-19 pandemic and officially proclaims that it is working to ensure that vaccines are safe, effective, and available for all following a rigorous procedure that includes: validation tests in the laboratory, studies in large clinical trials, evaluation by the European Medicines Agency, and authorization by the European Commission for the whole of Europe after consultation with all member countries. But even in democratic Europe, nationalism influences voters. So, Boris Johnson asked the British regulatory authorities to approve the Pfizer & BioNtech vaccine. Mass vaccination started from the first in the Western world. We read that Boris’s political situation a few days after Brexit is not the best. Therefore, one can imagine why he did it, as well as perhaps the risk of having to pay duties if everything had happened after the breakup.

Phase 3 studies must take place where the infection affects many people. For example, in China, the cases are practically eliminated except in people who come from other countries, so a study that follows the rules of a correct clinical trial it is not technically possible. Consequently, the vaccines are going tested in other nations where the virus is doing more victims like Brazil. In the United States, which has the largest number of cases in the world, Chinese vaccines are not tested, of course. But China, in its great power, has started collaborations with many other countries, poor and rich, like the United Arab Emirates to penetrate those markets, using the vaccine as a Trojan horse. The same for Russia with Turkey and perhaps in the future also with Hungary, feeling part of the European Union and a little not.

It is important to note that the largest vaccine experiment in history is starting. Thanks to modern technologies, it will be possible to evaluate and ascertain the safety of vaccines in an extremely superior way compared to when the two vaccines for polio were introduced in the 1950s. A few weeks ago, the World Health Organization declared Africa polio-free. This infection could be declared eradicated if pockets do not persist where there is fighting, where there are religious exploitation and where those who go to vaccinate children risk their lives. The combination of interests to keep the arms market profitable and religious fanaticism play on the ignorance of poor people and leave us insecure that we are not all defended. Then the bill is paid by the most vulnerable patients or the immunosuppressed.

Highest Efficacy Vaccine Regulatory Documents Hacked From EMA Server

Highest Efficacy Vaccine Regulatory Documents Hacked From EMA Server

Highest Efficacy Vaccine: The regulatory submission by the two prominent companies in race to get their respective vaccine candidate a go-ahead were accessed in a cyberattack, confirmed the European Medicines Agency (EMA). While this does not affect the timeline of the approvals to come in and respective dosage deliveries, it does pose a certain worry. 

EMA has not said anything explicitly about the attack but BioNtech has expressed concern over the fact that their documents were indeed accessed. Both documents pertaining to the regulatory submission of Pfizer and BioNtech were accessed. 

It is however known that EMA has made this news public in the interest of the world in order the data is not reused inappropriately. EMA is also assessing the viability of the Moderna vaccine, whose records apparently were not accessed in the cyber-attack. 

A few months back, a similar cyber-attack disturbed the trials of the Oxford University vaccine candidate. It was later discovered that indeed, Kremlin might have instigated the attack indirectly through well-known Russian cyber attackers. 

The Pfizer and BioNtech doses are both being considered the most effective in fighting the corona virus. Inoculations have already started in the UK. European Union has not been happy about Britain’s stand to go all out in the dissemination of a vaccine that had not received a full clearance from EMA anyway. 

The cyber-attack comes the day before the agency is due to update the European Parliament on the progress of the vaccine assessments.

The only big worry now is that if the documents have been downloaded or copied in the attack, they could be extremely valuable to other countries and companies rushing to develop vaccines. At the moment ,Russia is struggling to make its Sputnik V vaccine to work for its country, while the vaccine has only been tried and tested on a few participants and its efficacy isn’t effective. 

Elaborating on the risks of information being misused, Marc Rogers, founder of a volunteer group fighting Covid-related breaches, CTI-League made a media statement stating that, “When it comes to the data submitted to these kinds of regulatory bodies, we are talking confidential information about the vaccine and its mechanism of action, its efficiency, its risks and known possible side effects and any unique aspects such as handling guidelines.” Further,  ‘it can also provide detailed information on other parties involved in the supply and distribution of the vaccine and potentially significantly increases the attack surface for the vaccine.’

Why Should EU Be Vehement Of UK Emergency Vaccine Authorisation Move?

Why Should EU Be Vehement Of UK Emergency Vaccine Authorisation Move?

EU Be Vehement Of UK: The European counterparts are not happy with the way Britain has become the first western country to have fast tracked licensing of a Covid-19 virus vaccine. They feel the country has prioritized speed over the authenticity and efficacy of the vaccine, without taking into consideration public opinion.

According to EU European Medicines Agency, UK has not won the public confidence, and gone through the speedy approval route (emergency authorization), something even the European Union could have also adopted.  But “we worked on the premise that the idea is not that we’re the first to give to the world a vaccine, but the idea is to have safe and effective vaccines in the pandemic and that we can create confidence, and nothing is more important than confidence with respect to vaccines,” said German Health Minister  Jens Spahn.

UK has approved of the Pfizer and BioNTech led vaccine candidates to be rolled out into the market from next week.  Ironically, the second one has been developed in Germany itself, which holds the stance that in solidarity of being with the EU, all the nations believe in ‘moving together in unity’. 

The EU bloc isn’t happy with the way UK is calling this a win for the UK only because of their Brexit decision. They are also turning away their faces from claims that this is an historic win for the UK itself. Alok Sharma, the UK business secretary, might have carelessly claimed that the emergency authorisation was a British success story. “In years to come, we will remember this moment as the day the UK led humanity’s charge against this disease,” he said.

German Ambassador to UK, Andreas Michaelis, in a re-tweet had to set the record straight when he said, “Why is it so difficult to recognise this important step forward as a great international effort and success? I really don’t think this is a national story. In spite of the German company BioNTech having made a crucial contribution, this is European and transatlantic.”

Indeed the EU isn’t happy with the way Britain is siding for its own. But then, they should let go off Britain, as quickly as Boris Johnson has resumed a new identity and is taking all the steps he must to ensure the welfare of his own turf. 

UK approves Pfizer-BioNTech’s Covid-19 vaccine, to be rolled out next week

UK approves Pfizer-BioNTech’s Covid-19 vaccine, to be rolled out next week

UK approves Pfizer: United Kingdom has lodged its name in history by becoming the first country to have authorized the use of a Covid-19 vaccine. MHRA (Medicines and Healthcare Products Regulatory Authority) has approved emergency use of the Pfizer-BioNTech’s Covid-19 vaccine from next week. The 95% efficient vaccine against coronavirus will be rolled out next week for those most at risk. MHRA was given authority by government of UK to approve Covid-19 vaccine before January 1 as it gains complete power to authorize medicines in UK post Brexit. 

Pfizer has relayed of first vaccine lot to arrive in few days. UK, like many other first world nations, had bought 40 million doses of the Pfizer vaccine when it was showing high probability of success. These doses are targeted to immunize 20 million people in UK. Final trials have shown the vaccine to be 95% efficient with no adverse effects. 

Spokesman from Department of Health and Social Care said, “The government has today accepted the recommendation from the MHRA to approve Pfizer/BioNTech’s Covid-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.”

Commencing next week, the vaccine jabs will be given to people in high risk category, including elderly, immunocompromised patients, and frontline workers. The pharma giant has told that 10 million of vaccine doses will soon be available. First 800,000 doses will be supplied to UK in coming days. Covid-19 vaccine by Pfizer and BioNTech is the first vaccine to have completed its journey from concept to final approval in a short period of 10 months. It is to be noted that no regulatory step or developmental phase has been skipped in development of this highly anticipated vaccine. 

UK Prime Minister Boris Johnson posted a tweet on the historic development “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”

On the protocol of immunization to be followed next week onwards, Health Secretary Matt Hancock said that people will be contacted by NHS on their turn to receive the immunization. He said, “I’m confident now with the news today that from spring, from Easter onwards, things are going to be better and we’re going to have a summer next year that everybody can enjoy.” 

Following the approval, at least 50 hospitals across the country along with vaccination centre venues are being set up for the immunization drive. NHS Chief Executive, Sir Simon Stevens has said that the country’s healthcare system is preparing for “the largest scale vaccination campaign in our country’s history.”

UK authorities have prepared a “provisional priority list” to draw in people at maximum risk of contracting the virus. These include on priority the residents and staff of care home facilities, people over 80 years of age, and healthcare and social workers. These groups will receive the first stock of jabs starting as early as next week. Experts indicate that as more stocks of vaccine would be procured in 2021, mass immunization of other groups will initiate. These will include people over 50 years and young people with pre-existing conditions. This will ensure equitable distribution of vaccine across the demography and geographies. 

The vaccine is to be given in two shots and 21 days apart. Second dose is given as a booster to the first. Experts say that it takes few days for the body to develop immunity against the SARS-CoV-2 virus, and thus the booster dose is necessary. 

The ideal temperature requirement of this vaccine storage is -70C but the firms say that for up to 5 days the vaccine can be stored in refrigerator at 2-8C temperature. This will make transportation of vaccines easier logistically.

Even after getting vaccinated people still must stay vigilant and follow all the guidelines and regulations set up by the authorities in relation to the coronavirus infection. This implies that following social distancing, wearing face masks, testing, contact tracing, and isolation on being exposed are still to be followed with utmost diligence. 

A big challenge for Pfizer-BioNTech’s Covid-19 vaccine

A big challenge for Pfizer-BioNTech’s Covid-19 vaccine

A Big challenge for Pfizer-BioNTech’s Covid-19 vaccine: The week commenced with a positive note as American pharma giant Pfizer and its partner German firm BioNTech announced that their Covid-19 vaccine is 90% efficient with no major side effects. The news brought good news for stock markets as the numbers raised amid hopes of return to normalcy with an effective Covid-19 vaccine. Governments across the world have started scrambling to procure, store and prepare for vaccine roll-out. But equitable distribution of vaccine to all the nations, especially poorer and more vulnerable, will pose as a major hurdle. 

The biggest challenge with this particular vaccine is storage – it requires to be stored at -70C (-94F). This is a bitter news for low economy nations, like Africa, which is already plummeting with vaccine storage infrastructure. 

Major economies like US and European Union are already on track with establishing logistics for the vaccine once it is procured by the manufacturing giant. Two huge facilities, equipped with bulk freezers have been set up in Kalamazoo, Michigan in US, and in Puurs, Belgium. These facilities will function as the central point of storage and shipping of coronavirus vaccine by Pfizer-BioNTech. 

Kroll, a risk consulting firm’s Managing Director, Nick Doyle underlines, “It’s going to be a monumental challenge. We do have a duty of care for international populations. The poorer countries in the world, especially in sub-Saharan Africa, South America and Asia, are going to find this challenging.”

Though the development of promising and efficacious Covid-19 vaccine is extremely gratifying, the problem isn’t solved for poorer nations of Africa and Southeast Asia who are struggling to even have one functioning vaccine refrigerator. 

Pfizer and BioNTech, post affirming more data, are planning to apply for emergency approval of vaccine in US and regulators by the end of this month, and then commence shipping to other nations by December. US has already blocked a bulk of 100 million doses, while EU has ordered for 200 million and UK 40 million. Pfizer is under process to accomplish supply of 50 million doses of its coronavirus vaccine by the end of this year and 1.3 billion doses by next year. The centres in Puurs and Kalamazoo have already started manufacturing thousands of doses. More “freezer farms” are on stand-by to provide storage for vaccines in Pleasant Prairie, Wisconsin, and in Karlsruhe, Germany. 

Customized storage boxes have been prepared by Pfizer that can keep the vaccines at a maintained ultra-cold temperature using dry ice (solid carbon dioxide). These re-usable suitcase-sized boxes will be used to transport 1000 to 5000 doses and can maintain the temperature for up to 10 days. Pfizer has said that the vaccine can be then stored at fridge temperatures of 2-8C for up to 5 days. 

The custom-made boxes can be GPS tracked and also inform the Pfizer control station of temperatures being maintained in the transport trucks. Pfizer is hoping to transport about 25 lorries a day full of these boxes to enable rapid distribution from these centres to airports, moving round 7.6 million doses per day. 

Logistic firms like FedEx, UPS and DHL are also working to strengthen and streamline their operations and logistics for smooth transportation of vaccines. UPS has built storage freezer farms, one each in US and Netherlands, which can hold around 800 deep freezers and keep vaccines at -80C temperature. DHL and FedEx are also building storage units and keeping refrigerated lorries on stand-by. 

Germany has also set up 60 vaccination centres which are equipped with freezers for vaccine storage at ultra-low temperatures. 

Other Covid-19 vaccines that are being developed and are under phase 3 of clinical trials do not require such low temperatures. Vaccine by US firm Moderna can be kept at -20C temperatures, like in home refrigerators. AstraZeneca-Oxford vaccine can be stored and shipped in unfrozen state. 

Following couple of weeks and months will keep governments and pharma giants Pfizer and BioNTech on their toes as they scramble to manufacture and roll out the vaccine in a most unhinged and smooth fashion to all nations in an equitable way. 

Why Is South America Becoming Ideal Ground For Covid-19 Vaccine Trials?

Why Is South America Becoming Ideal Ground For Covid-19 Vaccine Trials?

South America in Covid-19 Vaccine Trials. Imagine being chosen as the ideal place for testing and developing a vaccine because there are the highest number of cases of infections there. It is a pity but this exactly the reason that pharmaceutical companies are heading to South America. 

As soon as a vaccine comes out, most residents of the smaller provinces of South America feel they will not be on the priority list for the vaccine. Most locals’ complaint is that they seem to have been forgotten and feel used for the trails. 

Companies like German Biontech and Curevac are preferring to be in South only because the high local infection rates makes it for an ideal testing ground. The world continues to races to find an effective vaccine against the coronavirus. 

The various administrations in Panama and Peru for example see an economic advantage in being chosen as a trial ground. Peru for example has become the first testing ground. Belavista district of Peru has reasons not to be bothered about a possible vaccine because they say that they have not even received support from their government in the time of the pandemic. 

Brazil has already seen many pharmaceutical companies set up shop too. In Sao Polo for example, America giant Pfizer and Germany company Biontech are busy testing people. They are using volunteer subjects that are being administers with candidate vaccines or a placebo. None of them paid for being used as Guinee pigs. 

Cepic is a Portuguese company that undertakes specialized clinical trials.  According to the Director of Cepic, Cristino Zerbini, “Most of our subjects are commoners working to make ends meet. We think this vaccine will be effective.” They feel proud to be associated with these clinical trials. 

Trials seem to be most aggressively underway in Brazil that anywhere else. This is again because the country has the largest number of Corona virus cases. Biontech is confident that it can receive approval for its vaccine before the end of 2020. Curevac is still going to carry out trials in Panama too. This is another country thathas high infection rates, a fact that is helping to ascertain the effectiveness of the vaccine. For Panama, this is an economic advantage over the rest of the world.

Sharing technology is also a part of the important deal between pharma
companies and countries holding such trials. But whether the common man who is participating in the trial will be let down by their respective government, or will they get a dose to protect themselves first; is something that will have to be left for time to tell.

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