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.
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.
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.
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 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.
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”.
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.
“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.
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.
The Pfizer vaccine has yet to receive the necessary regulatory approvals for use in Israel but Netanyahu said he expected it to receive clearance “in the very near” future.
The results of third-phase clinical trials showed that the vaccine was 90 percent effective in preventing Covid-19 symptoms and did not produce adverse side effects among thousands of volunteers.
Britain started inoculating its citizens with the vaccine on Tuesday.
Israel has also contracted to buy six million Covid-19 vaccine doses from US biotech firm Moderna which are expected to be delivered in 2021, giving a total of 14 million shots for its population of nine million.
Both medications require two doses to be administered for optimal protection.
The Pfizer vaccine needs to be stored at the ultra-low temperature of -70 degrees Celsius (-94 Fahrenheit), posing handling and storage challenges.
– ‘Amazing’ facilities – At the airport, Netanyahu praised “our amazing logistical storage centre, which is a few minutes from here, with refrigeration and the highest medical standards in the world”.
Israel imposed a second nationwide lockdown in September, when the country had one of the world’s highest per capita infection rates.
Restrictions have since been gradually eased but infection rates are again on the rise.
On Monday, Netanyahu’s office announced a sweeping night-time curfew but it has so far not received the cabinet approval required for its implementation and no details have been published.
Israel’s government has not yet commented on whether its vaccine procurement would cater for Palestinians in the occupied West Bank or the Gaza Strip.
The Palestinian Authority says that over 75,500 people have so far been infected with coronavirus in the West Bank and 712 have died.
In the Israeli-blockaded Gaza Strip there have been about 25,500 infections and 155 fatalities.
On Monday, the strip’s Hamas rulers said Gaza had received 20,000 test kits from the World Health Organization, after warning it could no longer perform testing due to a shortage of equipment.
Facing a surge in cases, Hamas has also announced a lockdown on weekends lasting from December 11 to the end of the month. It also closed schools, universities, kindergartens and mosques.
Pfizer and BioNTech will deliver the first doses of their Covid-19 vaccine to Canada this month, Prime Minister Justin Trudeau announced Monday, with inoculations to start as early as next week.
“Canada has secured an agreement with Pfizer to begin early delivery of doses of their vaccine candidate,” Trudeau told a news conference.
“We are now contracted to receive up to 249,000 of our initial doses of Pfizer BioNTech’s Covid-19 vaccine in the month of December,” he said.
Pending Health Canada regulatory approval, expected this week, the prime minister said the first shipments to 14 sites across Canada could be delivered next week, with millions more doses to follow in 2021.
The federal government has contracted with several pharmaceutical companies — including AstraZeneca, Pfizer and BioNTech, Sanofi and GSK, Novavax, Johnson & Johnson, Medicago and Moderna — to secure more than 400 million vaccine doses for its population of 38 million.
The US giant Pfizer and its German partner BioNTech’s vaccine is at the most advanced stage, having proved 95 percent effective in late-stage clinical trials and already secured approval in Britain where its world-first rollout is to begin Tuesday.
Ottawa in August signed a deal with Pfizer for 20 million doses plus options for millions more.
It poses some logistical challenges, however, including that it must be stored at extreme sub-zero temperatures and requires two doses given a week apart to be effective.
Major-General Dany Fortin, who is leading Canada’s vaccine rollout, said it will take only one or two days after it arrives to “unpack, thaw, decant, mix” and inject it into the arms of Canadians.
Europe’s medicines regulator said Tuesday it would decide by December 29 whether to grant emergency approval to a Covid-19 vaccine developed by Germany’s BioNTech and its US partner Pfizer, ahead of a rival treatment from Moderna.
The European Medicines Agency (EMA) confirmed that it had received formal applications from both vaccine makers seeking the green light for their experimental jabs.
“If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine,” the Amsterdam-based agency said it could conclude its assessment of the BioNTech/Pfizer shot in an extraordinary meeting on 29 December “at the latest”.
A separate meeting to assess the Moderna shot would take place on January 12 at the latest, it added.
Large-scale trial data released last month showed that both vaccines were safe and around 95 percent effective against Covid-19.
European Commission spokesman Stefan de Keersmaecker told reporters that once the EMA had given regulatory permission, formal authorisation from Brussels would follow “very quickly”, probably “in a matter of days”.
Although both vaccines are being assessed in an accelerated process known as a “rolling review”, the latest timeline suggests Europeans would be lucky to receive the first jabs before the year is over.
BioNTech/Pfizer and Moderna have also applied for emergency use authorisation in the United States, where Americans are expected to start getting vaccinated around mid-December.
UK regulators, who because of Brexit no longer have to wait for the EMA’s okay, are also in the process of considering emergency approval of the BioNTech/Pfizer vaccine.
– ‘Ready to ship’ –
BioNTech and Pfizer said they had asked the EMA for “conditional market approval” (CMA) of their vaccine on Monday, after filing a request for emergency authorisation in the US on November 20.
If approved by the EMA, the vaccine could potentially be rolled out “in Europe before the end of 2020”, the companies said in a statement.
“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer CEO Albert Bourla said.
A CMA can be granted “in emergency situations in response to public health threats”, the EMA says on its website.
Fellow vaccine frontrunner Moderna, a US biotech firm, meanwhile said it had sought emergency approval for its Covid-19 shot in both the US and Europe on Monday.
The BioNTech/Pfizer and Moderna vaccines have been developed at breathtaking speed as part of an unprecedented effort to end a pandemic that has killed more than 1.4 million people worldwide and devastated the global economy.
Both are based on a new technology that uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that makes human cells create a protein from the virus.
This trains the immune system to be ready to attack if it encounters the novel coronavirus.
No mRNA vaccines have ever been approved for widespread use.
– Highly effective –
As well as proving highly effective in preventing Covid-19, both vaccines were found to be consistent across all age-groups — a primary concern for a disease that hits the elderly the hardest — as well as genders and ethnicities.
But there are important differences between the two.
Moderna’s vaccine can be kept in long-term storage at minus 20 degrees Celsius (minus four degrees Fahrenheit) while Pfizer’s requires minus 70 degrees Celsius (minus 94 degrees Fahrenheit).
On the other hand, the Pfizer/BioNTech doses are much smaller — 30 micrograms to Moderna’s 100 micrograms — probably lowering production costs per dose.
It remains unclear how long exactly protection against Covid-19 might last, and both vaccines will likely require a booster shot.
Pfizer and BioNTech have previously said they expect to manufacture up to 50 million doses of their vaccine globally this year, and up to 1.3 billion doses by the end of 2021.
Moderna has said it aims to have approximately 20 million doses of its vaccine, called mRNA-1273, available in the US by the end of the year.
It expects to manufacture 500 million to one billion doses globally next year.
According to the World Health Organization, around 100 vaccine candidates are currently in development. Around a dozen of them are in the final phase three stage when the shot is tested on tens of thousands of volunteers.
A vaccine developed by AstraZeneca and Oxford University may be rolled out in the UK before the end of the year.
Pfizer and BioNTech had announced that a completed study shows that their experimental COVID-19 vaccine is 95 percent effective.
“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,” Pfizer CEO Albert Bourla said during the announcement
Pfizer was quoted as saying it would be able to supply 50 million doses by the end of 2020, and around 1.3 billion by the end of 2021.
Ogbuagu is an associate Professor of Medicine, in the clinician-educator track and Director of the HIV Clinical Trials program of the Yale AIDS Program, Section of Infectious Diseases of the Yale School of Medicine.
Ogbuagu’s profile on the website of Yale School of Medicine states that his clinical responsibilities include educating and training medical students, residents, and infectious diseases fellows in various capacities in inpatient and outpatient settings; and through structured course work and other teaching sessions.
“As a faculty of the HIV training track of the Yale-Internal Medicine primary care program and for over 6 years as a faculty of the Human Resources for Health program in Rwanda, I have extensive experience with curriculum development, structuring of residency training programs, and mentoring residents and faculty. In Rwanda specifically, I have and continue to mentor medical residents and junior faculty in quality improvement and clinical research projects that are locally relevant and addressing important infectious diseases-related problems (particularly HIV/AIDS and antimicrobial resistance).
“Furthermore, I have facilitated meaningful educational and research collaborations between faculty and trainees across institutions. As the program director of World Bank and HRSA-funded efforts supporting the Liberia College of Physicians and surgeons (LCPS)–run Internal medicine residency training program, I have overseen the selection and deployment of faculty to Liberia, and am responsible for educational programs and activities aimed at strengthening the residency training program. Overall, my expertise and collective experiences to date have positioned me to design and run successful projects around capacity building in low-resource settings including developing and implementing innovative and robust medical training and research programs for faculty, fellows, residents, and students.”
For five years now, Ogbuagu has been the Director of the Yale AIDS Program HIV clinical trials program, and a principal investigator on numerous pharmacokinetic, phase 2 and 3 safety and efficacy trials of novel antiviral compounds (HIV).
More, recently, given the alarming rate of new infections among men who have sex with men (MSM), he has focused on HIV prevention trials including being a co-principal investigator on a Yale CIRA funded project, which has supported the formation of a cohort of men who have sex with men, who are at high risk for HIV and are engaged in HIV PrEP services in order to study the impact of substance use on retention in care and adherence to PrEP.
He is also the lead investigator on the international DISCOVER trial evaluating TAF/FTC vs TDF/FTC for HIV prevention among MSM and transgender women.
He is Yale’s principal investigator on multiple investigational therapeutic and preventative clinical trials for COVID-19 including remdesivir (now FDA approved), leronlimab and remdesivir and tocilizumab combination therapy as well as the Pfizer/BioNTech Vaccine trial.
-A UNICAL Graduate With Many Honours-
Ogbuagu studied medicine at the University of Calabar, Cross River state, in 2003. After graduation, he interned at the Ebonyi State University Teaching Hospital, Abakaliki, Nigeria.
He then proceeded to intern at Mount Sinai School of Medicine (Elmhurst), New York. He rose to become a chief resident at the same school after which he became a fellow of infectious diseases, Yale University School of Medicine, New Haven, Connecticut.
In 2015, Ogbuagu became a fellow at, American College of Physicians. In 2017, he was a nominee for Charles W. Bohmfalk Award in Clinical Science, Yale University School of Medicine. In the same year, he won the Steve Huot Faculty Award for Dedication and Excellence, Yale University School of Medicine Internal Medicine Primary Care programme.
In 2019, Ogbuagu was awarded the Gerald H. Friedland award for outstanding international research. In 2020, he emerged as a nominee for Charles W. Bohmfalk Award in Clinical Science, Yale University School of Medicine.
-US Missions Recognition-
United States Diplomatic Mission Nigeria also recognised his contribution to the world of Medicine. In a tweet on Monday, November 23, they said, “Our hats off to Dr. Onyema Ogbuagbu at Yale who helped develop a COVID-19 vaccine!”
Nigerians contribute to the world in so many ways. Our hats off to Dr. Onyema Ogbuagbu at Yale who helped develop a COVID-19 vaccine! pic.twitter.com/DYFWHlJSFM