South African Firm Makes Africa’s First mRNA COVID-19 Vaccine

In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP
In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP

 

A South African biotech firm said Thursday it has produced the first mRNA Covid vaccine made on the continent using Moderna’s sequence and that it will be ready for clinical trials in November.

Cape Town-based Afrigen Biologics and Vaccines is leading the pilot project, backed by the World Health Organization (WHO) and the COVAX initiative, to tweak Moderna’s shot.

“At laboratory scale we have a vaccine that we now need to test,” Afrigen’s managing director Petro Terblanche, told AFP, adding that the first shot was ready during the second week of January.

READ ALSO: Germany To Offer 4th COVID-19 Jab To Vulnerable People

Tests on animals will start next month, “but the human studies will only start around November 2022,” she said after meeting a group of officials sponsoring the project.

Afrigen researchers sequenced the publicly available genetic code that Moderna used to make their vaccine, made the DNA and the RNA, and produced their own shot.

“We are the first to take the sequence developed by Stanford University and used by Moderna for their great vaccine, to design and develop a vaccine produced at laboratory scale,” she said.

And “we have completed the process from the design to a final formulation, but it’s small scale, but it’s a good start, it’s a fabulous start,” the laboratory chief said.

“This is the first yet very important step in empowering low- and middle-income countries to create a fully integrated vaccine production sector.”

She spoke after the UN-backed global Medicines Patent Pool gave the firm a 39 million euro ($45 million) grant.

Their mRNA vaccine can be kept at warmer temperatures, making it easier to store in low- and middle-income settings. The original jab requires expensive -25°C to -15°C refrigeration.

‘Health security, vaccine equity’

Charles Gore, MPP’s executive director, said in a statement that his organisation was “delighted to support Afrigen and its African partners to greatly expand local manufacturing capacity and reduce today’s gross inequity.”

The grant will cover the technology transfer hub’s work for five years, through 2026.

The French government funds the MPP’s activities linked to the hub.

“We will keep supporting this project… it’s a very important one for the world and for Africa,” the French ambassador to Pretoria, Aurelien Lechevallier, said after touring the lab.

The MPP is an international organisation that supports development of medicines for low- and middle-income countries.

Set up in July, the tech transfer hub will train other countries and hand out production licences to poor nations left out in the race for the life-saving shots.

“Its aim is to allow for greater and more diversified vaccine manufacturing capability, strengthen African regional health security and respond more equitably” to the current and future pandemics, a statement said.

Africa is the least vaccinated continent in the world.

More than a year after the world’s first Covid shot was administered and two years into the pandemic itself, just 11.3 percent of Africans have been fully immunised.

The problem has exposed Africa’s huge dependence on imported vaccines and its tech weakness compared with Europe, China and the United States.

To date only one percent of the vaccines used in Africa are produced on the continent of some 1.3 billion people, which has reported some 239,000 Covid deaths since the start of the pandemic.

Other players involved in the Cape Town hub set up in July are Biologicals and Vaccines Institute of Southern Africa (Biovac), the South African Medical Research Council, and Africa Centres for Disease Control and Prevention (Africa CDC).

 

AFP

Full Booster Dose Improves Omicron Protection, Says Moderna

Medical staff prepare Moderna coronavirus vaccines for use at the newly-opened mass vaccination centre in Tokyo on May 24, 2021. (Photo by Carl Court / POOL / AFP)

 

Giving a full dose of Moderna’s Covid-19 vaccine as a booster shot provides more antibody protection against the Omicron variant than currently authorised half-strength injections, the company said Monday.

The lab study measured the levels of Omicron-neutralising antibodies in blood samples from 40 people who had low levels of these antibodies before getting the booster.

The current recommendation is to give 100 micrograms of the Moderna jab as a first and second dose for protection from Covid-19, followed by a 50-microgram booster.

Antibodies were measured 29 days after booster participants got the third jabs, with half getting a 50 microgram dose and half getting 100 micrograms.

Moderna says preliminary data show antibody response to Omicron at the 50 microgram dose increased 37-fold — but when the dose was doubled, antibody levels increased 83-fold.

Moderna CEO Stephane Bancel called the results “reassuring”, adding that the company is continuing to develop an Omicron-specific jab.

The statement says clinical trials for a targeted vaccine are likely to begin in early 2022.

Experts urge caution when interpreting lab studies, saying real-world evidence is needed to determine protection against transmission and illness.

Last week a real-world study from South Africa showed two shots of the similar mRNA jab from Pfizer/BioNTech offered around 70 percent protection against severe disease caused by Omicron.

In an interview published Monday in French daily Le Monde, BioNTech CEO Ugur Sahin said that after a third injection the jab seemed to provide between 70 and 75 percent protection against any form of the illness.

He added that his company should be able to offer an Omicron-specific vaccine from March, pending approval from regulators.

Moderna Boss Warns Against Omicron Vaccine Struggle

In this file photo Moderna vaccines are seen kept on the table at a Covid-19 vaccine at Florida Memorial University Vaccination Site in Miami Gardens, Florida on April 14, 2021. Photo by CHANDAN KHANNA / AFP)

 

Existing Covid-19 inoculations will struggle against the fast-spreading Omicron variant, the head of vaccine manufacturer Moderna warned Tuesday, as countries ramp up vaccination programmes and impose further restrictions in an effort to curb growing concern.

First reported to the World Health Organization in South Africa less than a week ago, the new strain has rapidly spread from Africa to the Pacific, and from Europe to North America as dozens of countries have announced travel restrictions.

While no deaths have yet been reported from Omicron, and it could take weeks to know how infectious and how resistant the strain may prove to vaccines, its emergence underscores how besieged the world remains by Covid-19, nearly two years after the first cases were recorded.

Stephane Bancel, the head of US vaccine manufacturer Moderna, told the Financial Times in an interview published Tuesday that data would be available on the effectiveness of vaccines in the two weeks’ time, but that scientists were pessimistic.

“All the scientists I’ve talked to … are like ‘this is not going to be good’,” Bancel said, warning against a “material drop” in the effectiveness of current jabs against Omicron.

Moderna, US drugmaker Pfizer and the backers of Russian vaccine Sputnik V have all announced that they are already working on an Omicron-specific vaccine.

Scientists in South Africa said they had detected the new variant with at least 10 mutations, compared with three for Beta or two for Delta — the strain that hit the global recovery and sent millions worldwide back into lockdown.

China warned that the fast-spreading Omicron variant would cause challenges in hosting next February’s Winter Olympics in Beijing, with thousands of athletes, media and participants arriving from overseas required to enter a strict “closed-loop” bubble.

‘Urgent action’

“I think it will definitely lead to challenges linked to prevention and control,” foreign ministry spokesman Zhao Lijian said.

“But China has a lot of experience in responding to Covid-19,” Zhao added. “I firmly believe the Winter Olympics will be conducted smoothly.”

On Monday, US President Joe Biden said the strain was “a cause for concern, not a cause for panic,” stressing that he does not foresee new lockdowns or extending travel restrictions for now.

G7 health ministers called for “urgent action” to combat the Omicron variant.

The WHO said the overall risk from Omicron was “very high” and warned that any major surge would put pressure on health systems and cause more deaths.

Omicron could slow the recovery of the US economy and labour market and heighten uncertainty over inflation, Federal Reserve Chair Jerome Powell is to tell the Senate Banking Committee on Tuesday.

Governments, particularly in western Europe, had already struggled with rapid rises in case numbers and have reintroduced mandatory mask-wearing, social-distancing measures, curfews or lockdowns — leaving businesses fearing another grim Christmas.

Germany’s outgoing Chancellor Angela Merkel was to meet remotely with her successor, Olaf Scholz, and regional leaders Tuesday on whether to toughen up restrictions to tame raging infections in the European Union’s largest economy.

Germany’s constitutional court has ruled that sweeping restrictions such as curfews, school closures and contact restrictions were lawful, likely to pave the way for further curbs with hospitals, already over capacity, long sounding the alarm.

Bans for unvaccinated

“Contacts must be reduced,” said Germany’s vice-chancellor-in-waiting Robert Habeck, calling for tougher restrictions such as banning unvaccinated people from “all public facilities” apart from essential shops.

On Tuesday, Greece said coronavirus vaccines would be compulsory for over 60s, a day after Britain said all adults would be now eligible for a third Covid jab. On Tuesday, Norway also said it would offer a booster shot to all adults before Easter, as preferable to lockdown.

And in Switzerland, ahead of what some had hoped would be a prosperous ski season, hoteliers said they were facing a wave of winter cancellations following quarantine restrictions being imposed on travellers from certain countries, including Britain.

Hotels had seen “massive cancellations of corporate events and Christmas parties,” said industry group HotellerieSuisse, calling on political leaders to take steps to avoid a lockdown and to maintain financial assistance to the sector already hard hit by the pandemic.

A ministerial meeting on the World Trade Organization, which had been due to take place this week in Geneva but which was postponed due to Omicron, could now take place in early March 2022, the body said.

The first confirmed case of the Omicron variant was in South Africa on November 9, with infections spreading rapidly in the country.

Russia, which has the highest toll from the virus in Europe and which has not yet reported a case of the Omicron variant, on Tuesday recorded its lowest total new daily infections since October 15.

Kazakhstan has banned flights from December 3 to Egypt, a popular tourist destination, over Omicron.

Global Markets Slammed By Moderna’s Omicron Vaccine Warning

This creative image taken in a studio in Paris on November 16, 2020, showing a syringe and a vaccine vial with the reproduced logo of a US biotech firm Moderna. (Photo by JOEL SAGET / AFP)

 

World stocks slid Tuesday after Moderna warned current vaccines might be less effective at fending off the Omicron variant, and after eurozone inflation spiked to a record high.

Frankfurt, London and Paris followed Asia sharply lower, with sentiment dogged by fears of fresh economic fallout from the long-running Covid crisis.

Oil prices took a tumble following the Moderna remarks, which have reignited stubborn concerns over energy demand.

The markets selloff accelerated as data showed eurozone inflation rocketed on runaway energy prices to a record 4.9 percent.

‘Markets hate uncertainty’

“It only took one comment from the boss of drugs firm Moderna to derail markets once again,” noted AJ Bell investment director Russ Mould.

“Markets hate uncertainty, and this is precisely what we have now. No-one knows how much trouble the new variant is going to cause.”

Moderna chief executive Stephane Bancel’s comments, in an interview with the Financial Times, sent traders running for cover.

“There is no world, I think, where (the effectiveness) is the same level … we had with Delta,” Bancel told the newspaper.

The high amount of mutations on Omicron and its swift spread in South Africa indicated the present jabs would need to be tweaked, he indicated.

In foreign exchange, the euro rose Tuesday as data showed eurozone inflation soared in November to more than double the European Central Bank’s 2.0-percent target.

Sky-high inflation has placed intense pressure on the ECB and the US Federal Reserve to rein in vast stimulus programmes — with traders also fearing premature interest rate hikes to tame prices.

However, the emergence this week of the Omicron mutant coronavirus strain has complicated the picture.

‘Inflation drumbeat continues’

“The inflation drumbeat continues to sound, providing another reason to worry for beleaguered investors,” said IG analyst Chris Beauchamp.

“With central banks having done their utmost in the previous part of this (Covid) crisis, there is fear that they will be less able to act this time, and indeed may still continue on a tightening path.”

Later on Tuesday, markets will digest key testimony from US Treasury Secretary Janet Yellen and Federal Reserve chair Jay Powell.

“All eyes are again on US fiscal and monetary policy and if either official needed an excuse to continue to leave policy ultra-loose then the latest variant of the COVID-19 virus is surely it,” added Mould at AJ Bell.

In Britain, meanwhile, traders are also reassessing hopes of a pre-Christmas interest rate hike.

Prior to Omicron, the Bank of England had been forecast to lift rates to dampen near decade-high UK inflation.

“Hopes are fading that the Bank of England will raise interest rates later this month,” noted Hargreaves Lansdown analyst Susannah Streeter, citing the uncertain impact of the new variant.

Key figures around 1140 GMT

London – FTSE 100: DOWN 1.2 percent at 7,025.09 points

Frankfurt – DAX: DOWN 1.3 percent at 15,077.14

Paris – CAC 40: DOWN 1.3 percent at 6,691.62

EURO STOXX 50: DOWN 1.4 percent at 4,051.09

Tokyo – Nikkei 225: DOWN 1.6 percent at 27,821.76 (close)

Hong Kong – Hang Seng Index: DOWN 1.6 percent at 23,475.26 (close)

Shanghai – Composite: FLAT at 3,563.89 (close)

New York – Dow: UP 0.7 percent at 35,135.94 (close)

West Texas Intermediate: DOWN 2.8 percent to $68.02

Brent North Sea crude: DOWN 3.0 percent at $71.26

Euro/dollar: UP at $1.1356 from $1.1291 at 2200 GMT on Monday

Dollar/yen: DOWN at 112.87 yen from 113.53 yen

Pound/dollar: UP at $1.3343 from $1.3315

Euro/pound: UP at 85.07 pence from 84.80 pence

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

Moderna Reports Positive Results For COVID-19 Vaccine In Younger Children

(FILES): This creative image taken in a studio in Paris on November 16, 2020, showing a syringe and a vaccine vial with the reproduced logo of a US biotech firm Moderna, (Photo by JOEL SAGET / AFP)

 

US biotech firm Moderna said Monday its Covid vaccine was safe and produced a strong immune response in children aged 6-11, adding it would submit trial data to global regulators soon.

The news comes as a panel of government advisors was preparing to meet Tuesday on the question of whether to authorize the Pfizer vaccine in kids aged 5-11, with top infectious disease expert Anthony Fauci predicting it would be available by mid-November.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna chief executive Stephane Bancel said in a statement.

An interim analysis from a mid-to-late stage clinical trial of 4,753 children showed that two doses of vaccine produced a high level of neutralizing antibodies — Y-shaped proteins that bind to the coronavirus and block it from entering human cells.

The vaccine was dosed at 50 micrograms, which is half of what is used among adults, but still produced on average 1.5 times as many antibodies in children as it did in young adults given the higher dose.

The majority of adverse events were mild or moderate, including fatigue, headache, fever, and injection site pain.

These early results, released via a press statement, do not yet include a vaccine efficacy estimate, which may be expected at a later time once cases have accrued.

– FDA meeting on Pfizer –

The Moderna news comes as the US Food and Drug Administration (FDA) is preparing to convene a panel of advisors to vote on whether to greenlight the Pfizer shot for younger children, paving the way for 28 million more Americans to be vaccinated.

A briefing document posted on the FDA’s website indicated the agency believes benefits outweigh the most worrying side effect for this age group, namely myocarditis, or heart inflammation.

“The overall analysis predicted that the numbers of clinically significant Covid-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases,” the document said.

But it acknowledged the benefit-risk calculus would differ when community transmission is very low, as was the case in the United States in June 2021.

The FDA also uploaded Pfizer’s efficacy analysis, with the company estimating a two-dose course of its vaccine at 10 micrograms was more than 90 percent effective in preventing symptomatic disease.

Overall, more than 150 children aged 5 to 11 have died from Covid in the United States since the start of the pandemic, according to official data.

“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci told ABC News Sunday.

Moderna To Set Up $500m Vaccine Plant In Africa

In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP
In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP

 

Biotechnology company and COVID-19 vaccine maker Moderna says “it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year.”

In a statement released on Thursday, the company said it anticipates “investing up to $500 million in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site.”

The process for selecting the country and site is expected to commence soon.

READ ALSO: NAFDAC Approves Moderna And Sputnik Vaccines For Use

Moderna’s announcement is a victory for voices like the Director-General of the World Trade Organisation, Ngozi Okonjo-Iweala, who have called for vaccine manufacturers to ramp up investment in Africa.

“Since Moderna’s founding in 2010, our mission has been to make a transformative impact on human lives through our medicines. After a decade of pioneering the development of our mRNA platform, we have been humbled to play a critical role in combatting the COVID-19 pandemic globally with our mRNA vaccine. We view Moderna’s work as only just beginning,” said Stephane Bancel, Moderna’s Chief Executive Officer.

“On behalf of our growing team, partners and shareholders, we are determined to extend Moderna’s societal impact through the investment in a state-of-the-art mRNA manufacturing facility in Africa.

“While we are still working to increase capacity in our current network to deliver vaccines for the ongoing pandemic in 2022, we believe it is important to invest in the future.

“We expect to manufacture our COVID-19 vaccine as well as additional products within our mRNA vaccine portfolio at this facility.”

Nigeria Takes Delivery Of Over Four Million Moderna Vaccine Doses

 In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP
In this file photograph taken on June 29, 2021, a medical official holds a vial of the Moderna Covid-19 vaccine in Quimper, western France. Fred TANNEAU / AFP

 

The Federal Government on Monday took delivery of another tranche of COVID-19 vaccine doses.

The latest tranche, over four million doses of the Moderna vaccine, was donated by the US government.

Representatives from UNICEF and USAID officially presented the vaccine at a ceremony in Abuja.

According to AFP, the vaccines had arrived Nigeria on Sunday via two planes.

Nigeria had earlier kicked off its COVID-19 vaccination program in April after receiving 3.9 million doses of the AstraZeneca vaccine from the COVAX initiative.

Covax was set up to ensure the equitable distribution of vaccines, particularly to low-income countries, and has already delivered more than 80 million doses to 129 territories.

The Moderna vaccines, which were approved by NAFDAC in July, are expected to boost the country’s vaccination programme.

The virus has killed 2,149 people and infected nearly 174,000 in Nigeria, but the real figures are believed to be much higher, in part because of low testing rates.

Last month, the Nigeria Centre for Disease Control said it had detected the Delta variant, putting officials on alert for a third wave of infections in the country.

In June, Nigeria barred passengers who are not citizens or permanent residents from entering the country if they have been in South Africa in the past 14 days.

The decision followed similar restrictions imposed on travellers coming from Brazil, India and Turkey.

FG To Receive Over Four Million Doses Of Vaccines On Monday

A file photo of a healthcare worker holding a COVID-19 test kit. TARSO SARRAF / AFP

 

 

The Federal Government will on Monday receive more than four million doses of Moderna COVID-19 Vaccines, the National Primary Health Care Development Agency (NPHCDA) said on Sunday.

NPHCDA Executive Director/ CEO, Dr. Faisal Shuaib, in a memo issued to journalists in Abuja, said the consignment is a donation from the American government.

The expected shipment will be the largest of vaccines received since the nationwide COVID-19 vaccination campaign started in March this year.

Nigeria has run out of COVID-19 vaccines after an initial four million doses of AstraZeneca, received from the COVAX facility were utilized three weeks ago.

This comes days after Presidential Steering Committee on COVID-19 (PSC) called for strict compliance to the COVID-19 protocols in the conduct of all political events in the country.

READ ALSO: COVID-19 Third Wave: PSC Warns States, Political Parties To Ensure Strict Compliance

In a communique issued on Friday, the PSC Chairman and the Secretary to the Government of the Federation, Boss Mustapha, said the call followed recent confirmation of more cases of the Delta variant of COVID-19 in several states and the continued rising number of infections and hospitalization across the country.

He warned all political parties, State governments, Independent National Electoral Commission (INEC) and State Independent Electoral Commissions (SIEC) to avoid the spread of the virus amid political gatherings and ensure maximum public safety.

Meanwhile, Nigeria has recorded 497 newly confirmed COVID-19 cases as new infections continue to increase amid fears that the third wave of the pandemic has already hit the country.

In its latest update issued on Saturday night, the Nigeria Centre for Disease Control (NCDC) said the total number of cases in the country has risen to 173,908, with the new figure indicating a slight decrease from the 590 reported on Friday as the biggest daily figure since March.

The 497 new cases were recorded in 17 states and the Federal Capital Territory (FCT), with Lagos remaining the epicenter of the virus.

While the nation’s commercial capital recorded 211 cases, Akwa-Ibom State came second with 80 new cases while Kwara recorded 73 cases.

In the South-West, Osun State is ranked 4th on the list with 29 cases while Oyo and Rivers each raked in 17 cases. Cross River recorded 15, Anambra nine and Ogun eight.

NAFDAC Approves Moderna And Sputnik Vaccines For Use

 

A health worker prepares a dose to inoculate a woman with the Covaxin Covid-19 coronavirus vaccine at a school-turned-vaccination centre.
Tauseef MUSTAFA / AFP

 

The National Agency for Food, Drug Administration and Control has approved two more COVID-19 vaccines for use in Nigeria.

They are the Moderna and Sputnik vaccines.

Both vaccines were approved for emergency use, according to the Director-General of NAFDAC, Professor Moji Adeyeye, who announced the news on Thursday at a news conference in Abuja.

The agency had earlier approved the Oxford-Astrazeneca and Pfizer jabs, also for emergency use.

Professor Adeyeye explained that although the Sputnik vaccine, produced in Russia, has not yet been approved by the World Health Organisation, NAFDAC has carried out independent checks on the vaccine and found that the benefits outweigh the risks.

The approval comes as fears of a COVID-19 third wave in Nigeria continues to loom.

On Wednesday, the University of Lagos ordered students to vacate hostels on campus after a number of students reportedly contracted COVID-19.

The possibility of a third-wave has heightened after the Nigeria Centre for Disease Control reported the Delta variant of the virus in Nigeria.

The variant is believed to be more contagious and deadlier than its predecessors.

 

 

Moderna Says COVID-19 Vaccine ‘Highly Effective’ In Adolescents

Medical staff prepare Moderna coronavirus vaccines for use at the newly-opened mass vaccination centre in Tokyo on May 24, 2021. (Photo by Carl Court / POOL / AFP)

 

 

US biotech firm Moderna said Tuesday that trials had shown its Covid-19 vaccine is “highly effective” in adolescents aged 12-17 and the company would seek regulators’ approval in June.

“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents,” CEO Stephane Bancel said in a statement.

 

(FILES) In this file photo Moderna vaccines are seen kept on the table at a Covid-19 vaccine at Florida Memorial University Vaccination Site in Miami Gardens, Florida on April 14, 2021 (Photo by CHANDAN KHANNA / AFP)

“We will submit these results to the US FDA and regulators globally in early June and request authorization.”

 

(FILES) This file photo taken on November 18, 2020 shows a syringe and a bottle reading “Vaccine Covid-19” next to the Moderna biotech company logo. (Photo by JOEL SAGET / AFP)

 

If greenlit, as expected, it would be the second Covid vaccine authorized for use in US adolescents after Pfizer’s, which began rolling out this month for 12-to-15-year-olds.

The Moderna study enrolled 3,732 adolescents aged 12 to 17 and randomized, with two-thirds receiving the two doses of the vaccine and the rest receiving a placebo.

After two doses, no cases of symptomatic Covid-19 were observed in the vaccine group compared to four cases in the placebo group, meaning the shots were 100 percent effective.

Adolescents are less likely than adults to contract the illness.

Therefore the study also examined efficacy according to a more stringent definition of Covid, which requires just one symptom in addition to a positive test.

Under this definition, the vaccine was 93 percent effective after the first dose.

The vaccine, called mRNA-1273, was generally well tolerated, consistent with what has been observed in adults, with no significant safety concerns.

The majority of side effects were mild or moderate and included injection site pain, headache, fatigue, muscle ache and chills.

Although adolescents are much less susceptible to severe Covid than adults, experts believe they are important to reach in order to help achieve population immunity against the disease.

The US has reached almost 50 percent of its population of 332 million with at least one dose, but its vaccination campaign is slowing in the face of hesitancy.

President Joe Biden has set a target of having 70 percent of adults vaccinated with at least one dose by July 4. The current figure is almost 62 percent.

EU Watchdog Monitoring Pfizer, Moderna Jabs For Clot Risks

Used vials of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine against the novel coronavirus stand next to a syringe in a doctor’s practice in Suhl, Germany, on May 6, 2021.
Christof STACHE / AFP

 

Europe’s medicines watchdog said Friday it was checking whether Covid-19 vaccines made by Pfizer/BioNTech and Moderna could be linked to rare cases of blood clotting, but there was no indication so far.

The European Medicines Agency last month linked two other EU-approved vaccines, one made by AstraZeneca and another by Johnson & Johnson, to rare but occasionally fatal clots, however it stressed the vaccines’ benefits in fighting the coronavirus pandemic outweighed the risks.

The EMA’s safety committee “is closely monitoring whether mRNA vaccines might also be linked to cases of rare, unusual blood clots with low blood platelets.”

“Following a review of reports of suspected side effects, the (committee) considers at this stage that there is no safety signal for the mRNA vaccines,” the Amsterdam-based EMA said.

US drugs giant Pfizer and its German partner BioNTech as well as the US-based pharmaceutical Moderna base their vaccines on mRNA genetic technology that trains the body to reproduce spike proteins, similar to that found on the coronavirus.

When exposed to the real virus later, the body recognises the spike proteins and is able to fight them off.

So far, only few cases of blood clots with low blood platelets have been reported among the users of the mRNA vaccines.

Compared to the millions of people who have been vaccinated with them, “these numbers are extremely low, and their frequency is lower than the one occurring in people who have not been vaccinated,” the EMA said.

“In addition, these cases do not seem to present the specific clinical pattern observed with Vaxzevria and COVID-19 Vaccine Janssen,” the EMA said, using the brand names for AstraZeneca and J&J’s vaccines.

“Overall, the current evidence does not suggest a causal relation,” the medicines watchdog said.

The EMA also announced it has started reviewing data on a British and US-made antibody to treat coronavirus patients, but that it was too early to rule on its risks and benefits.

The EMA started a “rolling review” of data on sotrovimab, a monoclonal antibody developed by Britain’s GlaxoSmithKline and Vir Biotechnology based out of California.

Sotrovimab is a monoclonal antibody, a type of protein that attaches to the spike protein of the coronavirus, reducing its ability to enter the body’s cells.

The rolling review is a precursor to accelerated authorisation for use within the 27-nation European Union.

-AFP