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”.

Pfizer Seeks Authorisation For 3rd COVID-19 Shot As Vaccine Efficacy Drops

A medical worker shows a dose of the Pfizer-BioNTech Covid-19 vaccine on February 12, 2021 at the Tapparelli Retirement Home in Saluzzo, near Cuneo, Northwestern Italy, during a vaccination campaign for people over 80.
Marco Bertorello / AFP

 

 

Pfizer and BioNTech announced Thursday they would seek regulatory authorization for a third dose of their COVID-19 vaccine.

It comes after initial data from an ongoing trial showed a third shot pushed antibody levels five to 10 times higher against the original coronavirus strain and the Beta variant, first found in South Africa, compared to the first two doses alone, according to a statement.

“The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA (Food and Drug Administration), EMA (European Medicines Agency) and other regulatory authorities in the coming weeks,” the statement said.

In addition, the companies expect that a third dose will perform similarly well against the highly transmissible Delta strain, which is quickly becoming globally dominant.

Out of caution, the companies are also developing a Delta-specific vaccine, the first batch of which has been manufactured at BioNTech’s facility in Mainz, Germany.

The companies anticipate the clinical studies will begin in August, subject to regulatory approvals.

Based on drop-offs in efficacy seen in Israel after six months, the companies said they believe a third dose may be needed within six to 12 months after full vaccination

“While protection against severe disease remained high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected,” the statement said.

The FDA and US Centers for Disease Control and Prevention released a joint statement late Thursday saying authorities were studying “whether or when a booster might be necessary.”

“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said. “We are prepared for booster doses if and when the science demonstrates that they are needed.”

EU Approves Pfizer COVID-19 Vaccine For 12 To 15-Year-Olds

A laboratory technician holds a Pfizer-BioNTech Covid-19 vaccines at the Bidafarma wholesale distribution cooperative in Santa Fe, on the outskirts of near Granada, on January 21, 2021. JORGE GUERRERO / AFP
A laboratory technician holds a Pfizer-BioNTech Covid-19 vaccines at the Bidafarma wholesale distribution cooperative in Santa Fe, on the outskirts of near Granada, on January 21, 2021.
JORGE GUERRERO / AFP

 

The EU’s drug watchdog on Friday approved the Pfizer/BioNTech coronavirus jab for 12 to 15-year-olds, the first vaccine to get the green light for children in the bloc.

The vaccine was “well tolerated” in adolescents and there were no “major concerns” in terms of side effects, the Amsterdam-based European Medicines Agency said.

The move will be a further boost for Europe’s vaccination programme, with Germany saying it will start giving the jab to children over the age of 12 from next month.

The United States and Canada have already authorised Pfizer for adolescents.

READ ALSO: EU, AstraZeneca Battle In Court Over Vaccine Delays

“As anticipated, the EMA’s Committee for Human Medicines has today approved the use of the vaccine from Pfizer/BioNTech in adolescents from 12 to 15 years,” Marco Cavaleri, the EMA’s head of vaccine strategy, told a news conference.

Until now the shot made by US pharmaceutical giant Pfizer and German research firm BioNTech had only been authorised by the EU for people aged 16 and older.

EU Health Commissioner Stella Kyriakides hailed it as “one step closer to ending the pandemic”, but said people would still have the choice about whether their children should get the jab.

“Beyond the decisions of governments, this is ultimately a decision to be made by parents for their children,” she said on Twitter.

With EU countries trying to expand their vaccination coverage, EMA chief Emer Cooke has said the regulator fast-tracked the approval, which was originally expected in June.

‘Highly preventative’

The watchdog insisted that it had taken the necessary steps to ensure it was safe.

Trials showed the Pfizer vaccine was “highly preventative” for Covid-19 in children, the EMA’s Cavaleri said.

None of the 1,005 children who received the vaccine in a trial developed Covid-19, compared to 16 children out of the 978 who received a placebo injection.

“From a safety perspective, the vaccine was well tolerated and the side effects in this age group were very much similar to what we have seen in young adults and not raising major concerns at this point in time,” Cavaleri said.

The EMA confirmed it was looking into “very rare” cases of heart inflammation in people aged under 30 who had been given the Pfizer vaccine.

“Currently there is no indication that these cases are due to the vaccine and EMA is closely monitoring this issue,” it said in a statement.

US authorities have also reported a small number of reports of heart inflammation among some younger people who Pfizer and Moderna, which uses the same Messenger RNA technology.

The EMA said it was “working closely” with its US counterparts.

The approval of Pfizer for adolescents fires the starting gun for Germany to begin vaccinating children under 12, as Chancellor Angela Merkel announced on Thursday.

But Merkel stressed that vaccination would not be compulsory and would have no bearing on whether children can attend school or go on holiday.

Moderna has said it expects to seek authorisation from EU and US authorities in early June, after trials showed it was “highly effective” in adolescents.

 

AFP

BioNTech-Pfizer Say COVID-19 Vaccine 100% Effective On 12-15 Year Olds

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

 

BioNTech-Pfizer said Wednesday their vaccine showed 100 percent efficacy against the coronavirus in 12 to 15 year olds, as they eye approval for adolescents to get the jabs before the next school year.

Phase 3 trials carried out on 2,260 adolescents in the United States “demonstrated 100 percent efficacy and robust antibody responses”, the companies said in a statement.

“We plan to submit these data to (US regulator) FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year,” said Pfizer chief executive Albert Bourla.

Chief executive of German company BioNTech said the results showing high protection for teens were “very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant”.

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

Both the United States and the European Union have approved its use for people aged 16 and above.

Since then, it has been used in millions of adults in more than 65 countries.

READ ALSO: Biden To Unveil $2 Trillion ‘Once-In-A-Century’ Infrastructure Plan

A real world study involving 1.2 million people in Israel found it to be 94 percent effective.

With the world scrambling to inoculate, BioNTech said Tuesday it was on track to manufacture 2.5 billion doses of its vaccine this year.

The higher output was driven by the recent launch of a new production site in the German city of Marburg, which is now one of the world’s largest mRNA vaccine manufacturing plants, it said.

The vaccine is also being produced at a Pfizer plant in Belgium and at three sites in the United States.

BioNTech said improved efficiency and new cooperation agreements with outside partners had also helped lift its vaccine target, as had the regulatory nod allowing vaccinators to extract six instead of just five doses from a single BioNTech/Pfizer vial.

BioNTech and Pfizer last week began studies of the jab on children, with the first group of five-to-11 year olds getting the vaccine.

A younger cohort of two-to-five year olds are expected to get their first dose next week in the study which will also cover children as young as six months old.

AFP

Switzerland Authorises Pfizer/BioNTech COVID-19 Vaccine

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

 

The Pfizer/BioNTech vaccine has been authorised for use in Switzerland following a two-month rolling review, the Swissmedic regulatory authority said Saturday.

“After a meticulous review of the available information, Swissmedic concluded that the Covid-19 vaccine from Pfizer/BioNTech is safe and that its benefit outweighs the risks,” the body said in a statement.

It is the first vaccine against the new coronavirus that has been authorised for use in the wealthy Alpine nation.

“The safety of patients is an essential prerequisite, especially where the authorisation of vaccines is concerned,” said Swissmedic director Raimund Bruhin.

“Thanks to the rolling procedure and our flexibly organised teams, we nevertheless managed to reach a decision quickly — while also fully satisfying the three most important requirements of safety, efficacy, and quality.”

Switzerland, population 8.6 million, has secured around 15.8 million Covid-19 vaccine doses, in deals with three manufacturers.

It has signed contracts for around three million doses of the Pfizer-BioNTech vaccine, around 7.5 million doses of Moderna’s vaccine, and around 5.3 million doses of the AstraZeneca vaccine.

With all three manufacturers’ vaccines, two doses are required per person.

With Covid-19 cases and deaths still rising fast, the Swiss government announced Friday that restaurants and bars would be closed again across the country.

“The epidemiological situation is a cause of great concern,” the government said in a statement.

“The number of infections is very high and is continuing to rise. Hospitals and healthcare workers have been under extreme pressure for weeks and the festive period increases the risk of an even more rapid rise in cases,” it explained.

Switzerland is continuing to witness more than 4,000 new cases and 100 deaths each day.

In total, Switzerland has recorded more than 400,000 cases and nearly 6,000 deaths since the start of the pandemic.

-AFP

Singapore Approves Pfizer COVID-19 Vaccine

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP
An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP

 

Singapore has approved the Pfizer-BioNTech coronavirus vaccine, and expects to receive the first shipments of the shots by the end of December, the prime minister said Monday.

The city-state joins a handful of other countries around the world, including Britain and the United States, which have approved the jab.

Singapore hopes to have enough vaccines for its 5.7 million population by the third quarter of 2021, Prime Minister Lee Hsien Loong said in a televised address.

Priority will be given to those at most risk, such as health care workers, the elderly and vulnerable.

READ ALSO: SGF, Wife In Isolation As Household Members Test Positive For COVID-19

Vaccination would be voluntary, Lee said, but he was “strongly” encouraging people to get the shot.

“Because when you get yourself vaccinated, you are not just protecting yourself. You are also doing your part to protect others, especially your loved ones,” he said.

Lee also announced a further easing of virus curbs from December 28 as Singapore’s outbreak slows markedly, with weeks of barely any local transmissions.

The maximum number of people who can gather outside their homes and the number of visitors a household can host will be raised from five to eight, he said.

The number of people allowed in shopping malls, places of worship and attractions such as museums will also be raised.

Singapore initially kept Covid-19 in check through rigorous contact tracing but the virus later swept through dormitories housing low-paid migrant workers, prompting authorities to implement a partial lockdown.

Many businesses and schools were allowed re-open in June but Monday’s announcement is the biggest easing of curbs for months.

But Lee warned the situation was volatile and urged residents to continue to keep their guard up.

“This is absolutely not the time to relax and let our guard down, or to hold a big party imagining the problem has disappeared,” he said.

Singapore has reported more than 58,000 cases and 29 deaths.

While the city-state’s borders remain closed to most international visitors, life has slowly been returning to normal for many.

US Approves Pfizer Vaccine As Millions Of Doses Begin Shipping

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

 

The US green-lighted the Pfizer-BioNTech COVID-19 vaccine late Friday, paving the way for millions of vulnerable people to receive their shots in the world’s hardest-hit country.

President Donald Trump immediately released a video on Twitter, where he hailed the news as a “medical miracle” and said the first immunizations would take place “in less than 24 hours.”

It comes as infections across America soar as never before, with the grim milestone of 300,000 confirmed deaths fast approaching.

The US is now the sixth country to approve the two-dose regimen, after Britain, Bahrain, Canada, Saudi Arabia and Mexico.

The move came earlier than expected, and capped a day of drama after it was widely reported that the White House had threatened to fire Food and Drug Administration chief Stephen Hahn if he did not grant emergency approval Friday.

Trump’s intervention reinserts politics into the scientific process, which some experts have said could undermine vaccine confidence.

The US is seeking to inoculate 20 million people this month alone, with long-term care facility residents and health care workers at the front of the line.

The government also said Friday that it is buying 100 million more doses of the Moderna vaccine candidate, amid reports the government passed on the opportunity to secure more supply of the Pfizer jab.

The purchase brings its total supply of Moderna doses to 200 million, enough to immunize 100 million people with the two-shot regimen that could be approved as early as next week.

Both frontrunners are based on mRNA (messenger ribonucleic acid), a major victory for a technology that had never previously been proven.

Two other vaccine candidates stumbled Friday: France’s Sanofi and Britain’s GSK said their vaccine would not be ready until the end of 2021.

And in Australia, the development of a vaccine at The University of Queensland was abandoned Friday after clinical trials produced a false positive HIV result among subjects involved in early testing.

– Sputnik mix –
The mixed news on the vaccine front comes as infections accelerated fast in North America and parts of Africa but started to stabilize in Europe and drop in Asia and the Middle East.

Around the world more than 1.58 million lives have been lost to Covid-19 since it emerged in China a year ago, according to an AFP tally from official sources.

Brazil on Friday crossed 180,000 deaths, despite President Jair Bolsonaro’s insistence the crisis was at the “tail end.”

But across the Pacific Ocean, New Zealand, which has been praised for its handling of the virus, took its first tentative steps towards reopening its borders — with the tiny Cook Islands.

Countries which have approved the Pfizer-BioNTech jab meanwhile were preparing for roll out, as the World Health Organization warned of a potentially grim Christmas season.

Following Britain’s lead, the first vaccine shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later.

Israel, which accepted its first shipment of the Pfizer vaccine on Wednesday, is targeting a rollout on December 27.

And Hong Kong said Friday it had struck deals for two vaccines — one from Pfizer and the other from Beijing-based Sinovac — with plans to launch a campaign in early 2021.

A new combined approach is also being tested by AstraZeneca, whose Russian operation said it would mix its shot with the locally-made Sputnik V vaccine in clinical trials.

Russia and China have already begun inoculation efforts with domestically produced vaccines that have seen less rigorous vetting.

EU countries are eagerly awaiting clearance on the Pfizer and Moderna vaccines, in late December and early January respectively.

– Carbon down –
As Europe’s surge eases off slightly, France is planning to lift a six-week-long lockdown from Tuesday but impose a curfew from 8.00 pm, including on New Year’s Eve.

Greece also announced new plans Friday to slash quarantine time for incoming travelers and reopen churches for Christmas.

But Switzerland, which is seeing a sharp resurgence in cases, announced a 7:00 pm curfew for shops, restaurants and bars.

While lockdowns have brought economic pain, boredom and myriad other woes, the effect on the environment has been more positive.

Carbon emissions fell a record seven percent in 2020 as countries imposed lockdowns, according to the Global Carbon Project.

COVID-19 Vaccine Not Shown To Cause Female Sterilization

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP
An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.
JUSTIN TALLIS / AFP

 

Social media posts claiming that a Pfizer researcher found that the company’s COVID-19 vaccine will lead to infertility in women have been shared thousands of times. But independent medical experts and Pfizer said no sterilization was documented during clinical trials, and the researcher’s LinkedIn profile says he has not worked at the American pharmaceutical company since 2011.

“Head of Pfizer research: Covid Vaccine is female sterilization,” reads the headline of an article, a screenshot of which has been shared across Facebook, Instagram and Twitter since December 5, 2020. Posts making similar claims have been circulating in German and Portuguese.
The article cites former Pfizer researcher Michael Yeadon whose LinkedIn profile says he left Pfizer, where he worked on allergy and respiratory research, in 2011 — eight years before the start of the coronavirus pandemic.

Yeadon claims that the Covid-19 vaccine, which was first administered to the public on December 8, would train the immune system to attack a protein involved in placenta formation, syncytin-1, leading to infertility for women.

This is not how the messenger Ribonucleic Acid (mRNA) vaccine, developed in cooperation with the German company BioNTech, works, according to Dasantila Golemi-Kotra, an associate professor in microbiology at York University.

“The mRNA vaccine works by providing the body with an instructional molecule, such as mRNA, that tells the human cells how to synthesize the viral protein (the infamous spike protein),” she told AFP in an email.

The (mRNA) vaccine, such as the one developed jointly by Pfizer and BioNTech, does not contain any protein from the virus itself, but rather the instructions for the body to synthesize a viral protein so that the immune system learns to defend itself against it.

It differs from regular vaccines in that instead of confronting the immune system with part of a virus in a weakened or deactivated form to build antibodies, it gives it a “blueprint” of a part of the virus (the spike protein) that the body can then recognize and fight when confronted by it later.

Golemi-Kotra said: “The concern over the possibility that the anti-spike protein antibodies could attack the syncytin-1 protein of the placenta because the spike protein of the novel coronavirus shares a very short amino acid region with the spike protein is very small.”

She explained that the immune system can “recognize a surface in their target protein, which rarely is confined to a single short amino acid sequence.”

Sanjay Mishra, a Study Coordinator at Vanderbilt University, agreed, saying by email that “countless publications have shown that infection with SARS-CoV-2 induces antibodies against viral spike protein.

“Therefore it can be safely assumed that vaccination with the viral spike protein will also direct antibodies only against the targeted spike protein and nothing else,” Mishra said.

Annette Beck-Sickinger, professor at the University of Leipzig, said that “if this syncytin claim was true, every woman who has been previously infected with Covid-19 would consequently be infertile, but this is not the case.”

Although the Pfizer-BioNTech vaccine is the first to use mRNA commercially, mRNA was discovered in the early 1960s, with animal testing starting in the 1990s.

This vaccine “was tested, because of the scrutiny, with even higher standards in terms of how we do things,” Pfizer CEO Albert Bourla said during a briefing on December 8.

Dervila Keane, a Pfizer spokeswoman, also said that “there is no data to suggest that the Pfizer BioNTech vaccine candidate causes infertility.”

“It has been incorrectly suggested that Covid-19 vaccines will cause infertility because of a very short amino acid sequence in the spike protein of SARS-CoV-2 virus that is shared with the placental protein, syncytin-1,” Keane said.

“The sequence, however, is too short — 4 shared amino acids — to plausibly give rise to autoimmunity. Additionally, a cohort comparing the outcomes of pregnancies with and without intercurrent SARS-CoV-2 infection shows no difference in outcomes,” she added.

Although no evidence has been found of adverse effects on pregnant women so far, mostly because the clinical trials did not intentionally include pregnant women, the UK government advises to wait until the pregnancy is over to get vaccinated.

For the general population, “the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine,” Keane said.

It concluded that “the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2,” she said.

Details of the Pfizer trial can be found here.

A US Food and Drug Administration briefing document states that “the frequency of serious adverse events was low (<0.5%), without meaningful imbalances between (vaccine and placebo) study arms.”

The post also claims that the vaccine contains polyethylene glycol, an ingredient that the article says causes adverse effects including death.

The vaccine does contain a variation of the molecule, butthe additive “is not in a pure form, i.e. as just polyethylene glycol but as a chemical modified version of it… likely to make it amenable to the application,” York University’s Golemi-Kotra explained.

For people with documented allergies to the additive she said: “A consultation with a doctor is the best way to go.”

The full list of ingredients of the vaccine are available on the Canadian government’s website.

Canada approved the Pfizer-BioNTech vaccine on December 9, 2020 and previously announced that the country will receive up to 249,000 doses in December.

This vaccine and another mRNA candidate from pharmaceutical company Moderna are currently seeking emergency approval in the US.

Pfizer Vaccine Raises ‘No Specific Safety Concerns – US Regulator


Jack Hill / POOL / AFP

 

Data from 38,000 trial participants involved in testing the Pfizer-BioNTech Covid-19 vaccine revealed “no specific safety concerns,” a document issued by the US Food and Drug Administration (FDA) said Tuesday.

The data after two months of follow-up from the second dose of the vaccine “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorization).”

The document was released two days before an advisory committee of the FDA meets to decide on emergency approval, and the statement suggests that the regulator is inclined to green-light the vaccine.

More to follow . . .

Pfizer Seeks COVID-19 Vaccine Approval As US Cases Soar

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP
An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP

 

US giant Pfizer and its German partner BioNTech confirmed they would seek approval on Friday to roll out their coronavirus vaccine early as surging infections forced New York to shut schools and California braced for nighttime curfews.

The world is looking to scientists for salvation from the global pandemic but a second wave of infections is prompting a return to the shutdowns and closures that traumatised nations and upturned the global economy at the start of the year.

The first tangible signs of relief could come Friday when Pfizer and BioNTech file an emergency use authorisation request with the US Food and Drug Administration.

READ ALSO: Spain To Vaccinate Much Of Its Population By Mid-2021

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer chief executive Albert Bourla said. “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world.”

The scientific head of the US operation to develop a vaccine said the final green light would probably come in December.

No quick fix

The BioNTech/Pfizer shot and another one being developed by the US firm Moderna have taken the lead in the global chase for a vaccine.

EU Commission president Ursula von der Leyen said the European bloc could also approve both before the end of the year.

Spanish Prime Minister Pedro Sanchez said Friday he hoped to get “a very substantial part” of the nation of 47 million people vaccinated by mid-2021.

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)

 

But no immediate reprieve is coming and the new wave of the pandemic is hitting many regions harder than the first since the virus emerged in the Chinese city of Wuhan late last year.

Worldwide deaths are approaching 1.4 million and total infections nearing 57 million — although the true numbers are unknown since countries have different reporting methods and many cases go undetected.

India’s infections have surpassed nine million — second only to the United States — and some of its graveyards have been running out of room since it lifted restrictions to save the economy after the loss of millions of jobs.

“Initially when the virus broke (out), I thought I’ll bury 100-200 people and it’ll be done. But the current situation is beyond my wildest thoughts,” New Delhi gravedigger Mohammed Shamim told AFP.

And Mexico became the fourth country to see its death toll breach 100,000.

“We’re at a point where we don’t see a clear phase of descent,” former Mexican health ministry official Malaquias Lopez told AFP. “We don’t know where it’s going.”

Schools out in NYC

Current US numbers — more than quarter of a million deaths have been reported with 2,200 registered just on Thursday — have alarmed authorities enough to request that people stay at home for next week’s Thanksgiving holiday, when Americans usually travel from coast to coast to be with their families.

Not everyone is happy about the new rules.

More than 13,000 people have signed an online “Keep NYC Schools Open” petition after the city closed schools for its 1.1 million students but left open its bars and gyms.

An electronic billboard in Times Square announces "stocks soar on vaccine hopes" on November 9, 2020 in New York City. David Dee Delgado/Getty Images/AFP
An electronic billboard in Times Square announces “stocks soar on vaccine hopes” on November 9, 2020 in New York City. David Dee Delgado/Getty Images/AFP

 

“Indoor dining remains open. Gyms remain open. Nail salons and barbershops remain open. Only schools are threatened with closure. This is nonsensical,” the petition says.

California will also impose a 10 pm to 5 am curfew from Saturday — a measure that mirrors one that Istanbul will start imposing for its 15 million residents on weekends starting Friday night.

The latest restrictions in Europe include decision by Northern Ireland to shut its pubs and shops for an extra two weeks.

But health officials in France said three weeks of curfews and shutdowns appear to have helped the country pass the worst of its latest wave.

“Although indicators are still at high levels, they suggest that the peak of the second wave is behind us,” the country’s health agency said.

‘Extraordinary advances’

Governments are now pinning their hopes on a vaccine that can save them from business closures and the stay-at-home orders that put people’s mental health under severe strain.

A separate candidate vaccine being developed by the University of Oxford and AstraZeneca has been shown to be safe and effective in a smaller study of older adults.

The UK government hopes its production can be ramped up quickly if it passes its final hurdle in a phase 3 trial and is approved.

But the unprecedented speed at which the vaccines are being developed has raised some alarm.

China’s Sinopharm revealed Friday that it has already given its experimental vaccine to nearly a million people — including state employees and students heading to study abroad.

Top US infectious disease official Anthony Fauci sought to dispel concerns about the candidates from Pfizer and Moderna.

“The process of the speed did not compromise at all safety nor did it compromise scientific integrity,” he said. “It was a reflection of the extraordinary scientific advances in these types of vaccines.”

 

AFP

Pfizer, BioNTech Claim Experimental COVID-19 Vaccine Shows 95% Effectiveness

 

/ AFP)

 

Pfizer and BioNTech said Wednesday that a completed study of their experimental Covid-19 vaccine showed it was 95 percent effective.

They said the two-dose vaccine had no serious safety concerns and that the companies will apply for emergency use authorization from US regulators “within days.”

The announcement came as coronavirus cases are surging in the US and other parts of the world, and boosted hopes for an end to the pandemic that has upended life around the globe.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer CEO Albert Bourla.

“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” he added.

Pfizer had said last week after a preliminary analysis that its product was more than 90 percent effective.

On Monday another biotech firm involved in the race to develop a vaccine, Moderna, said its own vaccine was 94.5 percent effective, according to a preliminary analysis.

Pfizer has previously said it expected to contact the US Food and Drug Administration to apply for an Emergency Use Authorization by the third week of November.

The FDA had imposed a requirement on Covid-19 vaccine makers of having at least two months of follow-up with volunteers after their second dose, taken 28 days after the first, in order to ensure the drugs are safe.

Moderna developed its vaccine along with the US National Institutes for Health.

Both vaccines use mRNA (messenger ribonucleic acid) technology 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 SARS-CoV-2.

Other vaccines that are in late-stage trials, such as one being developed by Johnson & Johnson and another by Oxford University and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.

No mRNA vaccines have ever been approved, but Anthony Fauci, the United States’ top infectious disease scientist, told AFP Tuesday the technology had now “established itself.”

-AFP

Pfizer, BioNTech’s COVID-19 Vaccine Shows 90% Effectiveness After Trials

(FILES) In this file photo The Pfizer logo is viewed on their world headquarters in Manhattan on May 5, 2014 in New York City. AFP/ PHOTO

 

A vaccine jointly developed by Pfizer and BioNTech was 90 percent effective in preventing Covid-19 infections in ongoing Phase 3 trials, the companies announced Monday. 

The statement was released as coronavirus cases are soaring across the world, and European stock markets and oil prices jumped on the news.

According to preliminary findings, protection in patients was achieved seven days after the second of two doses, and 28 days after the first.

“The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer Chairman and CEO Albert Bourla said in a statement.

“We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” he said.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most.”

Across much of the globe, Covid-19 infections rates are hitting record highs, with hospital intensive care units filling up and death tolls mounting.

Based on supply projections, the companies said they expect to supply up to 50 million vaccine doses globally in 2020, and up to 1.3 billion doses in 2021.

US biotech firm Moderna, several state-run Chinese labs, and a European project led by the University of Oxford and AstraZeneca are thought to be closing in on potentially viable vaccines.

Two Russian Covid-19 vaccines have been registered for us even before clinical trials were completed, but have not been widely accepted outside of Russia.

The Phase 3 clinical trial — the final stage — of the new vaccine, BNT162b2, began in late July and has enrolled 43,538 participants to date, 90 percent of whom have received a second dose of the vaccine candidate as of November 8.

Pfizer said it is gathering two months of safety data following the final dose — a requirement of the US Food and Drug Administration — to qualify for Emergency Use Authorization, which it expects by the third week in November.

“We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” Bourla said.

– Dozens more candidates –

The so-called messenger RNA, or mRNA, the vaccine is a new approach to protecting against viral infection.

Unlike traditional vaccines, which work by training the body to recognise and kill proteins produced by pathogens, mRNA tricks the patient’s immune system to produce viral proteins itself.

The proteins are harmless, but sufficient to provoke a robust immune response.

The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

As of mid-October, the World Health Organization (WHO) has identified 42 “candidate vaccines” at the stage of clinical trials, up from 11 in mid-June.

Ten of them were at the most advanced phase 3 stage, in which a vaccine’s effectiveness is tested on a large scale, generally tens of thousands of people across several continents.

AFP