BioNTech To Ship Mobile COVID-19 Vaccine Labs To Africa

In this file photo taken on March 20, 2020 Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland one of the labs developing a vaccine for the coronavirus, COVID-19. PHOTO: ANDREW CABALLERO-REYNOLDS / AFP

 

Germany’s BioNTech, which together with Pfizer developed the first mRNA vaccine against the coronavirus, said Wednesday it plans to ship mobile vaccine production units to Africa.

“The question was, can we make the process compact enough to fit in a container,” the chief executive and co-founder of BioNTech, Ugur Sahin, told AFP as the company unveiled the new labs, dubbed “BioNTainers”.

BioNTech said it aims to establish the “first manufacturing facility in the African Union” in “mid-2022” and expects to ship the modular production units to Rwanda and/or Senegal.

Rwandan President Paul Kagame and his Senegalese counterpart Macky Sall attended the Vaccine Equity for Africa meeting at BioNTech’s mRNA production site in Marburg, Germany, along with Ghana’s President Nana Akufo-Addo and World Health Organization chief Tedros Adhanom Ghebreyesus.

“The modular system opens up new perspectives for global vaccine equity,” Kagame said.

Tedros said that boosting local production was “essential”, particularly as more than 100 countries worldwide had failed to attain the vaccination rate of 70 percent that the WHO had been targeting for the middle of this year.

READ ALSO: IMF Chief Urges G20 To Move Faster On Debt Relief

Africa is the least-vaccinated continent in the world — more than two years after the start of the pandemic and more than a year after the roll-out of the first coronavirus vaccines, less than 12 percent of Africans have been fully vaccinated.

Earlier this month, South African biotech company Biologics announced it had produced the continent’s first coronavirus vaccine based on mRNA technology using the genetic code that another mRNA vaccine maker, Moderna, had made publicly available.

Sahin said BioNTech, which developed its vaccine with US pharma giant Pfizer, has sold tens of millions of the shot and was aiming to “instal production sites for our mRNA technology on every continent”.

 

– Meticulous production process –

South Africa could “potentially” join the list of recipients of the mobile labs, BioNTech said.

The 12 units in total each comprise two modules — one for the production of mRNA and the other for the vaccine serum — and local partners then take over the filling of the vials.

The manufacturing process is made up of some 50,000 steps, each of which had to be followed meticulously.

But the containers overcome this challenge by having “the process pre-validated” before they are installed, Sahin explained.

Normally, it takes around three years to build a new factory. But using the mobile units, the first doses will be ready after 12 months, Sahin said.

The containers could also be used to produce vaccines against malaria based on mRNA technology, were it to be authorised after clinical trials planned to begin this year.

BioNTech employees will operate the containers to begin with, while training local employees “to hand over the site in the mid- or long-term”, according to the statement.

The vaccine technology will be shared without the patents behind it being waived, as requested by a number of countries and NGOs.

“Patents aren’t the key. When we install the technology and hand it over to a partner, they will also get the license to operate it,” Sahin said, adding that BioNTech would assure the “responsible use.”

AFP

Pfizer To Seek Green Light To Vaccinate Kids Five And Under

The Pfizer Covid-19 vaccine is prepared for administration at a vaccination clinic. Frederic J. BROWN / AFP

 

Pfizer and BioNTech will soon ask US regulators for emergency authorization for a Covid-19 vaccine for children aged five and under, US media reported Tuesday.

This is the last age group in the United States that is not yet eligible for coronavirus shots.

As early as Tuesday, the companies could seek emergency authorization for a two-dose vaccination regimen for children under five and as young as six months, The New York Times and other news outlets said.

The move comes as the Omicron variant wave is waning in the United States but parents are still grappling with school closures and concerns for their unvaccinated children.

New pediatric Covid hospitalizations hit a record high in the United States in December as the Omicron strain spread rapidly.

Last month, the Food and Drug Administration approved Pfizer’s Covid-19 booster shot for children as young as 12.

But vaccination rates among this age group are relatively low — less than 22 percent, according to the Centers for Disease Control and Prevention.

As they seek the green light for children under five to receive two doses of the vaccine, Pfizer and BioNTech will also continue studies on a three-shot regimen, the Times said.

The FDA hopes to approve shots for young kids as early as late February. Data on a three-dose regimen would not be submitted until late March, the daily added.

The companies concluded last fall that low doses of the vaccine provided protection in children up to two years old but not in kids aged two to five, announcing in December they would add a third dose to their trials.

“We know that two doses isn’t enough, and we get that,” a source told The Washington Post.

“The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”

Pfizer/Biontech Says Three Doses ‘Effective’ Against Omicron

A health worker shows a vial of the Pfizer-BioNTech vaccine against COVID-19 at the Pascual Guerrero Olympic stadium, in Cali, Colombia, on April 26, 2021. Luis ROBAYO / AFP

 

The coronavirus vaccine developed jointly by BioNTech and Pfizer is “still effective” against the Omicron variant of the virus after three doses, the companies said in a statement on Wednesday.

A laboratory study by its makers found the vaccine “is still effective in preventing Covid-19, also against Omicron, if it has been administered three times”, but warned that “the Omicron variant is probably not sufficiently neutralised after two doses”.

According to the study “a third dose provides a similar level of neutralising antibodies to Omicron as is observed after two doses” for other variants.

Pfizer and BioNTech also said that an Omicron-specific version of the anti-coronavirus vaccine, currently in development by BioNTech, would be available by March.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” Pfizer chief executive Albert Bourla said in a statement.

The new study comes after dozens of nations re-imposed border restrictions in response to the spread of the new virus variant and raised the possibility of a return of economically punishing lockdowns.

The detection of the first Omicron cases two weeks ago coincided with jumping infection numbers across the world, and the variant added fuel to concerns about a global Covid resurgence.

Omicron has so far been found in 57 countries, the WHO said. No deaths have yet been associated with the variant.

Scientists from the World Health Organization and the United States government told AFP this week the Omicron variant appeared to be no worse than other coronavirus strains but said more research was still necessary.

Pfizer, BioNTech And Moderna Make $65,000 Every Minute – Report

This file photo taken on April 20, 2021, shows an empty vial of the Moderna Covid-19 vaccine among empty vials of different other vaccines by Pfizer-BioNTech (Comirnaty) and AstraZeneca at the vaccination center in Rosenheim, southern Germany, amid the novel coronavirus
Christof STACHE / AFP

 

 

Pfizer, BioNTech and Moderna are making combined profits of $65,000 every minute from their highly successful Covid-19 vaccines while the world’s poorest countries remain largely unvaccinated, according to a new analysis.

The companies have sold the vast majority of their doses to rich countries, leaving low-income nations in the lurch, said the People’s Vaccine Alliance (PVA), a coalition campaigning for wider access to Covid vaccines, which based its calculations on the firms’ own earning reports.

The Alliance estimates that the trio will make pre-tax profits of $34 billion this year between them, which works out to over $1,000 a second, $65,000 a minute or $93.5 million a day.

“It is obscene that just a few companies are making millions of dollars in profit every single hour, while just two percent of people in low-income countries have been fully vaccinated against coronavirus,” Maaza Seyoum of the African Alliance and People’s Vaccine Alliance Africa said.

“Pfizer, BioNTech and Moderna have used their monopolies to prioritise the most profitable contracts with the richest governments, leaving low-income countries out in the cold.”

Pfizer and BioNTech have delivered less than one percent of their total supplies to low-income countries while Moderna has delivered just 0.2 percent, the PVA said.

Currently, 98 percent of people in low-income countries have not been fully vaccinated.

The three companies’ actions are in contrast to AstraZeneca and Johnson & Johnson, which provided their vaccines on a not-for-profit basis, though both have announced they foresee ending this arrangement in the future as the pandemic winds down.

PVA said that despite receiving public funding of more than $8 billion, Pfizer, BioNTech and Moderna have refused calls to transfer vaccine technology to producers in low- and middle-income countries via the World Health Organization, “a move that could increase global supply, drive down prices and save millions of lives.”

“In Moderna’s case, this is despite explicit pressure from the White House and requests from the WHO that the company collaborate in and help accelerate its plan to replicate the Moderna vaccine for wider production at its mRNA hub in South Africa,” the group said.

While Pfizer CEO Albert Bourla has dismissed technology transfer as “dangerous nonsense,” the WHO’s decision to grant emergency use approval to the Indian-developed Covaxin earlier this month proves that developing countries have the capacity and expertise, PVA added.

PVA, whose 80 members include the African Alliance, Global Justice Now, Oxfam, and UNAIDS, is calling for pharmaceutical corporations to immediately suspend intellectual property rights for COVID vaccines by agreeing to a proposed waiver of the World Trade Organisation’s TRIPS agreement.

More than 100 nations, including the United States, back that move, but it is being blocked by rich countries including the UK and Germany.

-AFP

No Need To Adapt Pfizer Vaccine For COVID-19 Variants, Says BioNTech Chief

File: JOEL SAGET / AFP

 

The first generation vaccine developed by BioNTech-Pfizer works against coronavirus variants such as the Delta strain and does not need to be modified for the moment, the chief executive of German company BioNTech said Monday.

“It is quite possible that in the next six to 12 months, further variants will emerge and that would require adaptation of the vaccine but it is at the moment not yet the case,” Ugur Sahin told journalists.

A decision to make a switch should be made only if it is clear that the vaccine failed to work or is only offering sub-par protection against the virus.

The fast-changing situation meant that getting the timing for the change right was also crucial.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating. Therefore the timing of the decision must be appropriate,” he said.

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“At the moment we have a good understanding that the booster vaccine with the parental strain is completely sufficient,” stressed Sahin.

BioNTech’s partner Pfizer has also repeatedly amplified the case for booster shots amid the latest wave of infections.

Countries including France and Germany have said they will begin offering the additional shot to the elderly and the most vulnerable from September.

BioNTech-Pfizer have shipped around one billion doses of their vaccines to more than 100 countries or territories around the world.

They are expecting their annual manufacturing capacity to reach three billion doses by year’s end, before climbing to four billion doses in 2022.

AFP

After COVID-19 Jab, BioNTech Sets Sights On Malaria Vaccine

A health worker shows a vial of the Pfizer-BioNTech vaccine against COVID-19 at the Pascual Guerrero Olympic stadium, in Cali, Colombia, on April 26, 2021. Luis ROBAYO / AFP

 

Germany’s BioNTech, which developed a coronavirus vaccine with US giant Pfizer in record time, said Monday it aimed to start trialling a malaria vaccine next year using the same breakthrough mRNA technology.

If successful, the vaccine could be a crucial step in the fight against the mosquito-borne disease, which kills more than 400,000 people a year — mainly young children in Africa.

“We will do whatever it takes to develop a safe and effective mRNA-based malaria vaccine that will prevent the disease, reduce mortality and ensure a sustainable solution for the African continent and other regions affected by this disease,” BioNTech CEO Ugur Sahin said in a statement.

The company said it will assess several vaccine candidates and begin clinical trials by the end of 2022.

The project is backed by the World Health Organization, the Africa Centers for Disease Control and Prevention and the European Union.

READ ALSO: World Bank To Finance Extra COVID-19 Jabs For Poorer Nations

BioNTech said it was also looking at setting up an mRNA hub in Africa so that future vaccines can be manufactured and distributed on the continent.

The planned malaria vaccine would use the same messenger RNA method that made its debut with the Pfizer/BioNTech coronavirus vaccine, which was the first jab against Covid to be approved in the West in late 2020.

The coronavirus jab developed by US rival Moderna also uses mRNA technology.

Scientists believe mRNA vaccines, which provoke an immune response by delivering genetic molecules containing the code for key parts of a pathogen into human cells, could be a game-changer against many diseases.

They also take less time to develop than traditional vaccines.

BioNTech’s Covid-19 shot was developed and approved by regulators in less than a year.

– ‘Realistic goal’ –

“We are witnessing the start of a revolution in medical science, the revolution of messenger RNA,” European Commission President Ursula von der Leyen said at Monday’s online launch event.

“Eradicating malaria is now a realistic goal and now we know that it can be achieved already in this generation.”

In a conference call with reporters, Sahin said he believed BioNTech’s malaria efforts have “a high likelihood for success”.

The fight against malaria received a boost in April when researchers from Britain’s Oxford University announced that their Matrix-M vaccine candidate had become the first to surpass the WHO’s threshold of 75-percent efficacy, in a study on infants in Burkina Faso.

A large-scale, final stage trial is ongoing.

AFP

Pfizer/BioNTech To Produce COVID-19 Vaccine In South Africa

In this file photo taken on December 8, 2020 a member of staff draws the Pfizer-BioNTech COVID-19 vaccine out of a phial at the Southmead Hospital, Briston. The US Food and Drug Adminstration on December 11, 2020 granted the Pfizer-BioNTech Covid-19 vaccine an emergency use authorization, paving the way for its imminent rollout across the country.
Graeme Robertson / AFP / POOL

 

COVID-19 vaccine makers BioNTech and Pfizer said Wednesday they will produce their jab in South Africa from 2022, a first for the continent that could see much-needed immunisation drives pick up speed. 

The move comes amid growing criticism of vaccine inequality that has seen poor countries fall behind richer ones in the race to protect people from the coronavirus.

Under the agreement, Cape Town-based Biovac will complete the last step in the manufacturing process of the Pfizer/BioNTech vaccine, known as “fill and finish”, the companies said in a statement.

The project will take time to get off the ground, however, with the first African-finished Pfizer vaccines not expected before next year.

Once up and running, Biovac is set to churn out more than 100 million doses annually that will be distributed to the 55 countries in the African Union.

“This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic,” said Biovac chief executive officer Morena Makhoana.

“Technical transfer, on-site development and equipment installation activities will begin immediately,” the statement added.

South African President Cyril Ramaphosa called the partnership “a breakthrough” for African nations.

The reaction from the World Health Organization was more muted.

“We welcome all initiatives to increase Covid-19 vaccine production in the future but immediate action is needed now,” a spokesman said.

In low-income countries, “only one percent of people have received at least one dose, compared with more than half of people in high-income countries,” he added.

The coronavirus vaccine developed by Germany’s BioNTech and its US partner Pfizer, based on experimental mRNA technology, was the first to be approved in the West late last year.

Studies have shown it is highly effective against Covid-19, including against newer variants.

Another plant in South Africa is already handling the fill and finish process for the Covid-19 shot developed by pharmaceutical firm Johnson & Johnson, which uses a traditional viral vector-based method.

– Debate over patents –
Calls have grown for pharma companies to waive patents on their life-saving jabs to speed up the pace of inoculations globally.

Washington and Paris have backed the suggestion, but the vaccine companies themselves are fiercely opposed.

German Chancellor Angela Merkel has also said that suspending intellectual property rights could stifle innovation and would not resolve the lack of manufacturing capacity in the short term.

She has instead argued for licensing agreements and partnerships between vaccine makers and local firms, the approach taken by BioNTech and Pfizer.

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses,” said Ugur Sahin, BioNTech’s co-founder and CEO.

Pfizer CEO Albert Bourla said weakening intellectual property “will only discourage the type of unprecedented innovation which brought vaccines forward in record time and make it harder for companies to collaborate going forward”.

– Vaccine hub –
Pfizer/BioNTech said they have so far shipped more than one billion Covid-19 vaccine doses to over 100 countries or territories, including through the Covax vaccine-sharing programme.

The Covax scheme, backed by the WHO and heavily relied on by African countries, has so far delivered far fewer doses than expected, however.

South Africa has the highest number of Covid-19 cases and fatalities in Africa, recording more than 2.3 million infections and over 67,000 deaths.

The country is currently battling a third wave of the pandemic, fuelled by a lack of vaccines, public fatigue with Covid restrictions and the highly contagious Delta variant.

South African President Ramaphosa last month announced a plan to turn his country into an mRNA vaccine hub, saying Africans “cannot continue to rely on vaccines that are made outside of Africa because they never come”.

BioNTech Co-founder ‘Confident’ Vaccine Works Against Indian COVID-19 Variant

A health worker shows a vial of the Pfizer-BioNTech vaccine against COVID-19 at the Pascual Guerrero Olympic stadium, in Cali, Colombia, on April 26, 2021.
Luis ROBAYO / AFP

 

BioNTech co-founder Ugur Sahin on Wednesday voiced confidence that the vaccine that his company jointly developed with Pfizer works against the Indian variant of the coronavirus. 

“We are still testing the Indian variant, but the Indian variant has mutations that we have already tested for and which our vaccine works against, so I am confident,” said Sahin.

“The vaccine is cleverly built and I’m convinced the bulwark will hold. And if we have to strengthen the bulwark again, then we will do it, that I’m not worried about,” he added.

India is facing surging new cases and deaths in the pandemic, and fears are rising that the variant could be contributing to the unfolding catastrophe.

The World Health Organization has said the B.1.617 variant of Covid-19 first found in India had as of Tuesday been detected in “at least 17 countries”.

The health agency recently listed B.1.617 — which counts several sub-lineages with slightly different mutations and characteristics — as a “variant of interest”.

But so far it has stopped short of declaring it a “variant of concern”, which would have indicated that it is more dangerous than the original version of the virus by, for instance, being more transmissible, deadly, or able to dodge vaccine protections.

The BioNTech-Pfizer vaccine was the first to win authorisation in the West and has since been deployed in dozens of countries worldwide.

Giving an update on the authorisation process in China, Sahin said the approval was “very possible in July”.

“We are almost through with all questions,” he said.

-AFP

EU To Get Four Million Extra Pfizer Doses For ‘Hotspots’

Files: JOEL SAGET / AFP

 

The EU will receive an extra four million BioNTech/Pfizer vaccine doses over the next two weeks to be deployed to Covid-19 “hotspots”, European Commission chief Ursula von der Leyen said Wednesday.

The delivery — over and above already agreed supplies from the vaccine-maker — will go to affected border regions within the bloc to “help ensure or restore free movement of goods and people,” she said in a statement.

The announcement came as von der Leyen’s commission attempted to persuade at least six member states — including her home country Germany — to lift virus-related border restrictions deemed by Brussels to be excessive.

It also follows a trip by the leaders of Austria and Denmark to Israel to form a vaccine-producing alliance that exemplified broad criticism of the lack of deliveries so far under the commission’s pre-purchasing scheme.

Von der Leyen said the four million extra BioNTech/Pfizer doses will be delivered “before the end of March” and will help member states deploy “their targeted use where they are most needed, in particular in border regions”.

She said they would go to “tackle aggressive variants of the virus and to improve the situation in hotspots”.

Von der Leyen pointed to steep rises in infections and hospitalisations in Austria’s Tyrol region, France’s Nice and Moselle regions, Bolzano in Italy, and parts of Germany’s Bavaria and Saxony regions.

Those had led to “stringent measures and even in certain cases to impose new border controls,” it said.

The statement noted that BioNTech/Pfizer’s mRNA vaccine was showing itself to be “highly effective” against the new variants.

It added that the four million extra doses would be made available for member states to buy on pro-rata basis according to their population size.

Von der Leyen called the additional agreement “quick and decisive action” on the part of her commission, and emphasised that restoring freedom of movement within the EU was “key for the functioning of health systems and the Single Market”.

AFP

BioNTech/Pfizer Say Vaccine Can Stand Warmer Temperatures

A health worker prepares a dose of the Pfizer-BioNTech vaccine against COVID-19 at Colombia University Clinic in Bogota, on February 18, 2021.
Raul ARBOLEDA / AFP

Germany’s BioNTech and its US partner Pfizer on Friday said tests have shown that their coronavirus vaccine can stand warmer temperatures than initially thought, potentially simplifying the jab’s complex cold-chain logistics.

The companies said they have asked the US Food and Drug Administration to allow for the vaccine to be stored for up to two weeks at minus 25 to minus 15 degrees Celsius (minus 13 to five degrees Fahrenheit), temperatures commonly found in pharmaceutical freezers and refrigerators.

Under the existing guidelines, the BioNTech/Pfizer jab needs to be stored at a frigid minus 80 to minus 60 C until five days before use, a delicate process that requires special ultra-cold containers for shipping and dry ice for storage.

READ ALSO: 31 Dead In DR Congo Plague Outbreak

“If approved, this new storage option would offer pharmacies and vaccination centres greater flexibility in how they manage their vaccine supply,” said Pfizer CEO Albert Bourla in a statement.

The BioNTech/Pfizer jab, based on novel mRNA technology, was the first vaccine against Covid-19 to be approved in the West late last year.

It was soon followed by US firm Moderna’s vaccine, which uses similar technology but can remain stable at minus 20 C for six months and at normal fridge temperature for up to 30 days.

Another approved shot, developed by AstraZeneca/Oxford, uses more traditional vaccine methods and can be stored and shipped at standard fridge temperatures.

BioNTech CEO Ugur Sahin said BioNTech and Pfizer were continuing to work on “new formulations that could make our vaccine even easier to transport and use”.

The firms have also started testing their Covid-19 vaccine on healthy pregnant women.

The trial involves some 4,000 pregnant women in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Britain and Spain.

Those in the US have already received their first dose, BioNTech and Pfizer said earlier this week.

Separately, a study focused on more than 9,000 medical staff at Sheba hospital near Tel Aviv showed that the first dose of the Pfizer vaccination is 85 percent effective against coronavirus infection between two and four weeks after inoculation.

AFP

BioNTech Starts Vaccine Production At New German Site

In this file photo taken on November 23, 2020 is pictured a bottle reading “Vaccine Covid-19” next to US pharmaceutical company Pfizer and German biotechnology company BioNTech logos on November 23, 2020. JOEL SAGET / AFP

 

German Covid-19 vaccine maker BioNTech said Wednesday it has started production at its new facility in Marburg, expected to significantly boost the EU’s vaccine supply.

“We have started the first step of vaccine production in our production facility in Marburg,” the company said in a statement.

The factory, whose launch was fast-tracked by German authorities, will produce mRNA, the active ingredient in BioNTech’s vaccine developed with US pharmaceutical giant Pfizer.

It will then be purified and concentrated before being transported to a “production partner” to be finished.

The European Medicines Agency (EMA) will carry out quality checks in February or March.

“The first vaccines produced at the Marburg site are expected to be delivered at the beginning of April,” BioNTech said.

READ ALSO: Prince Charles Receives First Dose Of COVID-19 Vaccine

The main European factory for producing the vaccine is Pfizer’s plant in Puurs, Belgium.

Once fully operational, the new Marburg site in Hesse state will be one of the largest mRNA production facilities in Europe, with an annual production capacity of up to 750 million vaccine doses.

BioNTech plans to produce up to 250 million doses there in the first half of 2021.

“We continue to work with Pfizer on a series of measures to meet global demand,” said the company, confirming its goal of delivering two billion doses in 2021.

BioNTech bought the Marburg plant from Swiss pharma giant Novartis last year to ramp up vaccine production, and retained the 300 employees already working there.

BioNTech had announced in mid-January that it would have to delay shipments of the jabs to the EU due to necessary modifications at the Puurs factory, sparking ire across the bloc.

But the company said in early February it would meet its contractual commitments for the first quarter and pledged to send up to 75 million extra doses to the bloc in the spring.

The EU has ordered a total of 600 million doses of BioNTech and Pfizer’s so-called Comirnaty vaccine.

Mutation-Beating Vaccine Can Be Made In ‘Six Weeks,’ Says BioNTech

 

 


JOEL SAGET / AFP

 

The co-founder of BioNTech said Tuesday it was “highly likely” that its vaccine against the coronavirus works against the mutated strain detected in Britain, but it could also adapt the vaccine if necessary in six weeks.

“Scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variant,” said Ugur Sahin.

But if needed, “in principle the beauty of the messenger technology is that we can directly start to engineer a vaccine which completely mimics this new mutation — we could be able to provide a new vaccine technically within six weeks.

-AFP