Phase Three Trials Begin For Novavax Vaccine In US, Mexico

KIRKLAND, WA – DECEMBER 28: Pharmacists prepare doses of the COVID-19 vaccine at the Life Care Center of Kirkland on December 28, 2020 in Kirkland, Washington. The Life Care Center of Kirkland, a nursing home, was an early epicenter for coronavirus outbreaks in the U.S. Karen Ducey/Getty Images/AFP

 

Clinical trials to determine the safety and efficacy of a Covid-19 vaccine candidate from American biotech company Novavax have begun in the United States and Mexico, the US National Institutes of Health (NIH) announced Monday.

A similar Phase 3 trial for the same vaccine, called NVX-CoV2373, is also under way in the United Kingdom, where about 15,000 volunteers have been recruited.

In the US and Mexico, the new trials will include around 30,000 volunteers over the age of 18.

Two-thirds of the participants will receive the vaccine and one-third a placebo. None of them will know, for the duration of the trial, what was in the injection they received.

“The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines,” said leading US immunologist Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

The goal is that at least 25 percent of the participants in the US and Mexico trials should be aged 65 and over, the statement said.

Emphasis will also be placed on recruiting people who are more exposed to Covid-19 — African-Americans and Hispanics in particular — or who present with underlying health conditions that put them at higher risk, such as obesity or diabetes.

READ ALSO: US Begins COVID-19 Vaccinations For Troops In South Korea

The vaccine is taken in two doses three weeks apart. It can be stored between two and eight degrees Celsius (35 and 46 degrees Fahrenheit) — much warmer temperatures than already approved vaccines from Pfizer/BioNTech and Moderna, meaning it could be more easily distributed.

The Pfizer and Moderna vaccines are based on a new technology, messenger RNA, while the Novavax vaccine is a recombinant protein vaccine.

The coronavirus has spikes (viral proteins) on its surface that come into contact with cells it infects. These proteins can be reproduced and presented to the immune system so that it can later recognize them and react if it is actually infected.

Two other vaccines that have conducted Phase 3 trials, those from Johnson & Johnson and AstraZeneca/Oxford, are expected soon to seek emergency authorization for distribution in the US, the country most affected by the pandemic in absolute numbers worldwide.

WHO In Talks With Pfizer, Moderna On COVID-19 Vaccine Access

This combination of file pictures created on August 05, 2020 shows a sign for Pfizer pharmaceutical company in Cambridge, Massachusetts, on March 18, 2017, and the Moderna headquarters in Cambridge, Massachusetts on May 18, 2020.  DOMINICK REUTER, Joseph Prezioso / AFP

 

The World Health Organization said Tuesday it is in discussions with Pfizer and Moderna about possibly including their high-tech coronavirus vaccines among early jabs for poor countries at affordable prices.

The WHO-backed Covax facility, created to ensure equitable access to Covid-19 vaccines around the world as they become available, is aiming to provide some two billion doses by the end of next year.

It has already secured hundreds of millions of doses of vaccine candidates being developed by AstraZeneca, Novavax and Sanofi-GSK.

WHO senior advisor Bruce Aylward said the organisation was looking at a range of other jabs, as well as the current frontrunners.

He said WHO was “in conversations” with Pfizer and Moderna about whether their products could be part of “early roll-out of vaccines”.

READ ALSO: Bomb Kills Deputy Governor In Afghan Capital

But, he stressed, “we also need to make sure that they are at prices that are appropriate for the populations we are trying to serve and the countries we are trying to help.”

US pharmaceutical giant Pfizer has, along with German BioNTech, created the first coronavirus jab to receive regulatory approval in a number of Western countries. Vaccination campaigns have already begun in Britain and the United States.

The Moderna vaccine is expected to quickly receive approvals as well.

– Light, but a long tunnel –
Both vaccines use cutting-edge technology and have been shown in Phase III trials to be highly effective — and they are expected to be expensive.

But Aylward hailed public comments from Pfizer chief Albert Bourla in which he talked about cutting prices for low-income countries.

“He has said we are committed to making sure that our products see global use and we recognise that requires pricing it at the right level to be able to make that work,” Aylward said.

“So there is a strong commitment from Pfizer out there to be able to do that.”

Covax wanted to have a diverse portfolio of vaccines to offer and would evaluate “any product out there with demonstrated efficacy, safety, quality”, he added.

The vaccines developed by China and Russia could also be evaluated for inclusion “if they meet the standards for efficacy and safety”, he said.

A year into the pandemic, which has claimed more than 1.6 million lives worldwide, Aylward hailed the positive vaccine news over the past month.

“There is light at the end of the tunnel,” he said. But while there was “a bright light at the end of it, getting brighter, it is a long tunnel.”

AFP

US Expert Committee Recommends Pfizer COVID-19 Vaccine Approval

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

 

 

An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.

The final voting tally was 17 in favor, four against and one abstention.

The committee was tasked with answering whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”

READ ALSO: Israel Gets First Delivery Of Pfizer COVID-19 Vaccine

The vote by the independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists, isn’t binding but the FDA is expected to follow the recommendation within the coming days.

Britain, Canada, Bahrain and Saudi Arabia have already approved the vaccine, the first in the world to complete a large-scale, phase 3 clinical trial.

Russian and Chinese vaccines are already being administered on a large scale, but without having completed comparable clinical trials.

The full results of the trial, which included nearly 44,000 people, were published Thursday in the New England Journal of Medicine, another major milestone.

These confirmed the vaccine was 95 percent effective with no serious safety issues, an outcome that was described in an accompanying editorial as a “triumph.”

Pfizer scientist Kathrin Jansen told the panel this was a result of the innovative messenger RNA technology behind the vaccine, an approach that has never before been approved.

Britain on Wednesday reported that two health care workers developed significant allergic reactions to the vaccine as the country rolled out its massive drive Tuesday.

The FDA will therefore include a warning label on the vaccine if it’s approved, the agency’s Marion Gruber said.

AFP

US Records Highest Daily COVID-19 Death Toll As Regulators Meet Over Pfizer Vaccine

Medical staff members Flor Trevino (L) and Susan Paradela attempt to change the bed sheet of a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 7, 2020 in Houston, Texas.  Go Nakamura/Getty Images/AFP
Medical staff members Flor Trevino (L) and Susan Paradela attempt to change the bed sheet of a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 7, 2020 in Houston, Texas. Go Nakamura/Getty Images/AFP

 

American regulators were due to meet Thursday to assess the Pfizer coronavirus vaccine for emergency approval, as the country logged one of its worst-ever daily Covid-19 death tolls with more than 3,000 people lost to the pandemic.

Other northern hemisphere countries were also grappling with a winter virus surge, as the number of global infections raced towards 70 million with more than 1.5 million deaths.

It is not confirmed when the US Food and Drug Administration will issue the emergency authorization for the Pfizer-BioNTech vaccine, but Health Secretary Alex Azar indicated that officials have early next week in mind.

“Now we actually get to do something that hopefully will bring this… pandemic to an end,” said Terri White, a nursing education specialist at UW Health in the state of Wisconsin, where staff are being trained to administer the vaccine.

“I know our whole team is really excited about that prospect… to help our lives return to normal.”

Top US government scientists said, however, that people with a known history of severe allergic reactions would be asked not to take the Pfizer vaccine, following a similar warning in Britain.

The United States is the worst-hit nation in the world, with more than 15 million known infections and close to 290,000 deaths.

US Army General Gus Perna, who is overseeing logistics nationwide, said he had given the order Wednesday to begin distributing syringes, needles, alcohol wipes and dilutants required for the Pfizer vaccine, a process expected to be completed by Friday.

The next vaccines to receive approval might be those made by Moderna, Johnson & Johnson, and AstraZeneca, most likely in that order.

The US hopes to vaccinate 20 million people this month, with long term care facility residents and health care workers at the front of the line. The goal is to reach 100 million by the end of February and the whole population by June.

‘I’m really excited’

After Britain gave the first approved vaccine shots in the Western world, Canada also approved the Pfizer-BioNTech vaccine on Wednesday.

The first shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later, according to Major-General Dany Fortin, the commander put in charge of coordinating distribution.

Healthcare workers and vulnerable populations including the elderly are to be the first to receive it.

A person takes a Covid-19 oral swab test at a pop-up community testing site in the Panorama City neighborhood of Los Angeles, California, December 9, 2020. Patrick T. Fallon / AFP
A person takes a Covid-19 oral swab test at a pop-up community testing site in the Panorama City neighborhood of Los Angeles, California, December 9, 2020.
Patrick T. Fallon / AFP

 

“I’m really excited. I want to get vaccinated as soon as possible, because I have a new baby,” Michelle, a Toronto resident, told AFP.

“She’s under six months old, and so obviously my main concern through the whole pandemic has been to protect her.”

Israel accepted its first shipment of the Pfizer vaccine on Wednesday, targeting a rollout on December 27, with Prime Minister Benjamin Netanyahu promising to be the first to be injected — although the vaccine has yet to pass regulatory hurdles there.

Both Russia and China have already begun inoculation campaigns with domestically produced vaccines.

‘I hope better days are coming’

As European countries eagerly await vaccines, the EU’s medical regulator was hit by a cyberattack in which documents related to the Pfizer vaccine were accessed, the firm said Wednesday.

The European Medicines Agency has promised to reach a decision on conditional approval for the Pfizer-BioNTech vaccine by December 29, with a ruling on Moderna’s candidate to follow by January 12.

But while wealthier nations have the financial and logistical abilities to roll out the vaccines, there are concerns that the poorer — and more vulnerable — parts of the world will be left behind.

African Union chairman Moussa Faki Mahamat said Wednesday that “those who have the (financial) means must not monopolize the vaccines.”

At an annual Christmas toy and food giveaway in a poor neighborhood of Belo Horizonte, Brazil, where Mrs Santa Claus embraced children from behind a plastic “hug curtain”, people hoped for an end to their suffering.

“I hope better days are coming,” said Valmira Pereira, a house cleaner. “That next year we’ll be able to give real hugs, be able to feel that human warmth that everyone’s been missing.”

Israel To Start COVID-19 Vaccinations On December 27

Israeli Prime Minister Benjamin Netanyahu speaks during a joint press conference with the Slovenian Prime Minister in Jerusalem on December 8, 2020. ohad zwigenberg / POOL / AFP

 

Israel will start Covid-19 vaccinations from December 27, Prime Minister Benjamin Netanyahu said on Wednesday, as the country received its first batch of Pfizer’s coronavirus vaccine.

Netanyahu, who was on hand as an air freighter carrying the vaccines landed at Ben Gurion airport, near Tel Aviv, vowed to be the first Israeli to get the jab.

The shipment was the first of eight million doses Israel ordered from pharmaceutical giant Pfizer and its partner BioNTech.

“This is a great celebration for Israel,” Netanyahu said as a fork-lift truck started unloading the cargo.

“The first vaccinations will be given on December 27,” he said later, noting the public health service would be capable of administering 60,000 inoculations a day.

“Tomorrow another shipment is arriving, a much larger one,” Netanyahu said.

“I’m asking that every Israeli citizen be vaccinated, and to do so, requested to set an example and be the first person being vaccinated in Israel,” he added, without saying when.

It came ahead of Hanukkah, the Jewish Festival of Lights, which begins on Thursday.

“We’ve brought great light to Israel,” he said.

The Pfizer vaccine has yet to receive the necessary regulatory approvals for use in Israel, but Netanyahu said he would be meeting with the health minister and heads of the public health system on Thursday to prepare “the massive national undertaking” of vaccinations.

The results of third-phase clinical trials showed 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 same 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 populaton 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.

‘End to the Plague’

Speaking 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 in the country but infection rates are again on the rise.

The virus has infected 349,916 Israelis, 2,934 of them fatally, according to Wednesday’s official figures.

While reiterating the need to keep up with “masks, distancing, hygiene and preventing gatherings,” Netanyahu was nonetheless upbeat.

“We’re bringing an end to the plague,” he said in his Wednesday evening address.

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.

On Wednesday evening, Netanyahu said the government would meeting the next day to finalise the restrictions set to be issued.

“We decided on taking the gatherings expected on the holidays, Hannukah, Christmas and the New Year, and limiting them to save lives,” he said.

Foreign Minister Gabi Ashkenazi meanwhile suggested Israel might provide vaccinations for Palestinians in the occupied West Bank or the Gaza Strip.

“We don’t rule out this opportunity once we will have the amount that we need for our first responders, health community and others, and as far as I know they have already engaged with some of the companies,” he said.

The Palestinian Authority says 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 enclave’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.

Israel Gets First Delivery Of 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

 

 

Israel received its first batch of Pfizer’s coronavirus vaccine Wednesday, with Prime Minister Benjamin Netanyahu declaring the pandemic’s end was “in sight” and vowing to get the first jab.

“This is a great celebration for Israel,” he said on the tarmac at Ben Gurion airport, near Tel Aviv, as a fork-lift truck started unloading the cargo from a red and yellow DHL air freighter.

The shipment was the first of eight million doses ordered from pharmaceutical giant Pfizer and its partner BioNTech.

It came ahead of Hanukkah, the Jewish Festival of Lights, which begins on Thursday.

“The end is in sight,” Netanyahu said about the disease which has infected 348,948 Israelis, 2,932 of them fatally, according to a Wednesday update.

“What is important to me is that Israeli citizens get vaccinated,” he added.

“I want to serve as an example to them and I intend to be the first to be injected with this vaccine in the state of Israel.”

Read Also: 90-Year-Old British Grandmother First To Receive Pfizer COVID-19 Vaccine

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.

 

This combination of file pictures created on August 05, 2020 shows a sign for Pfizer pharmaceutical company in Cambridge, Massachusetts, on March 18, 2017, and the Moderna headquarters in Cambridge, Massachusetts on May 18, 2020. DOMINICK REUTER, Joseph Prezioso / AFP

 

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.

AFP

Pfizer To Deliver First COVID-19 Vaccine Doses To Canada In December – PM

(FILES) In this file photo taken on February 14, 2020 Canada’s Prime Minister Justin Trudeau addresses a press conference at the 56th Munich Security Conference (MSC) in Munich, southern Germany. Thomas KIENZLE / AFP.

 

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.

 

Italy To Offer Free COVID-19 Vaccines, Starting With Doctors

(FILES) 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.

 

Italy will give all its citizens free vaccinations against coronavirus starting with doctors and care home residents once the jabs are approved, its health minister said Wednesday.

The immunisation drive is expected to begin in the spring. Italy will get its vaccines via an EU procurement programme and is waiting for the European Medicines Agency’s green light, Roberto Speranza said.

Britain on Wednesday became the first western country to approve a Covid-19 vaccine for general use, announcing the rollout of a vaccine developed by Germany’s BioNTech and its US partner Pfizer from next week.

Meanwhile, Europe’s medicines regulator has said it will decide by December 29 whether to grant emergency approval to Pfizer-BioNTech’s jab, ahead of a rival treatment from Moderna.

The latest timeline suggests Europeans would be lucky to receive the first jabs before the year is over.

Nonetheless, Speranza said: “We can finally see light at the end of the tunnel.”

“The vaccine will be distributed to all Italians for free. It will not be obligatory at first. The government will be monitoring how the campaign progresses,” he added.

Italy, the first European country to be hit hard by the pandemic early this year, has been battling a new surge in infections in recent months that has taken the total death toll past 56,000.

Shops, restaurants and bars in the worst-affected regions have been shut and a nationwide curfew was imposed, measures that Speranza said had brought infection rates down.

But he said Italians should prepare for restrictions to continue over the Christmas holidays.

“I warn you now: do not mistake the first ray of sunlight for an escape from danger,” he said, adding: “If we let down our guard now, the third wave is just around the corner.”

Speranza did not give concrete details of new measures that are due to come into force when the previous restrictions expire this week.

– ‘Discouraged’ –

But he said international travel over the festive season “should be discouraged” and travel between regions would likely be banned — a blow to those hoping to join their relatives in other parts of the country.

All movement between towns is expected to be forbidden on Christmas Day and December 26.

The Italian government is also joining Germany’s push for a ban on ski holidays across Europe over Christmas, amid fears resorts could become a major source of coronavirus infections. But it faces opposition from regional leaders, while Austria has said it would be economically disastrous.

“It will be necessary to avoid potential gatherings in places of tourist attraction linked in particular to skiing activities,” Speranza said.

The health minister said Italy has signed contracts for vaccines from AstraZeneca, Johnson & Johnson, Sanofi, Pfizer, CureVac and Moderna.

Once approval comes, doctors and health care workers will get the first doses — some 1.4 million people — followed by residents in care homes — just over 570,000 people.

Those aged over 80 will be next in line, followed by those aged between 60 and 79 years old and those suffering from at least one chronic disease.

Vaccines will then be distributed to key workers — teachers, police, prison wardens — before being offered to the general population at walk-in centres.

Speranza urged all lawmakers in Italy, where campaigners against vaccination are very vocal, to get behind the immunisation push.

“There’s no government majority or opposition on this, there are simply Italians,” he said.

AFP

Japan To Give Free COVID-19 Vaccine To Residents

In this file photo taken on August 13, 2020, a lab technician sorts blood samples for a COVID-19 vaccination study at the Research Centers of America in Hollywood, Florida. (Photo by CHANDAN KHANNA / AFP)

 

Japan will give free coronavirus vaccines to all of its residents under a bill passed Wednesday, as the nation battles record numbers of daily cases.

The bill, which says the government will cover all vaccine costs for Japan’s 126 million residents, was approved by the upper house of parliament, having cleared the powerful lower house.

The country has secured Covid-19 vaccines for 60 million people from pharmaceutical giant Pfizer, and for a further 25 million people from biotech firm Moderna.

READ ALSO: UK Approves Pfizer-BioNTech Vaccine For Rollout From ‘Next Week’

It has also confirmed it will receive 120 million doses of AstraZeneca’s vaccine.

Pfizer and Moderna are already seeking emergency-use approval in the United States and Europe, after clinical tests showed their jabs were effective.

The bill’s passage comes two weeks after Japan’s prime minister said the country was on “maximum alert” over the virus, and as medics warn hospitals are on the brink of collapse.

Japan has seen a comparatively small Covid-19 outbreak overall, with around 2,100 deaths and 150,000 cases, and has not imposed the strict lockdowns seen elsewhere.

But it is now facing a third wave of the disease, reporting record numbers of daily infections nationwide in recent weeks.

Tokyo’s governor has urged residents to avoid non-essential outings and asked businesses serving alcohol to shut early, although there is no enforcement mechanism for these recommendations.

The national government has also decided to allow individual regions to opt out of a controversial domestic tourism campaign.

AFP

UK Becomes First Country To Approve Pfizer-BioNTech 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

 

Britain on Wednesday became the first Western country to approve a Covid-19 vaccine for general use as it announced a rollout of Pfizer-BioNTech’s drug from next week.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the department of health said in a statement.

“The vaccine will be made available across the UK from next week,” the statement said. Priority groups will include care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

After months of “rigorous” clinical trials and thorough analysis of the data, the MHRA “concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the statement added.

“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS (National Health Service) to do its work without being overwhelmed.”

Pfizer chairman Albert Bourla said it was a “historic moment in the fight against Covid-19”.

 

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

 

“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” he said.

Pfizer and BioNTech added that they expected further regulatory decisions from other countries “in the coming days and weeks”.

The announcement came as England exited a month-long coronavirus lockdown, but most of the country remained under restrictions as a new regional system for cutting infection rates kicked in.

The four-week lockdown, which began in November, was imposed to stop surging rates of infection, ease pressure on health services, and to allow families to gather for Christmas.

Prime Minister Boris Johnson, a Covid survivor, succeeded in winning a vote on the measures in parliament late Tuesday, despite significant opposition within his own Conservative ranks.

READ ALSO: Croatia PM Plenkovic Contracts COVID-19

“All we need to do now is to hold our nerve until these vaccines are indeed in our grasp and indeed being injected into our arms,” he told lawmakers before the vote.

Until then “we cannot afford to relax, especially during the cold months of winter”, he warned.

AFP

EU Regulator To Decide On Pfizer/BioNTech COVID-19 Vaccine Approval

(FILES) 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

 

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.

No Sinister Plan Behind COVID-19 Vaccine, Says Nigerian-Born Doctor Leading Pfizer Research

Onyema Ogbuagu

 

Onyema Ogbuagu, a Nigerian-born researcher and medical doctor has dispelled misconceptions concerning the COVID-19 vaccine noting that there is no sinister plan in the development of the vaccine.

Ogbuagu is an Associate Professor of medicine at Yale University. He is one of those leading the research at Pfizer for a COVID-19 vaccine in the United States.

READ ALSO: Trump’s Son Don Jr Tests Positive For COVID-19

Speaking concerning some misconceptions about the vaccine, in a series on Tweet on his official handle, he said misinformation about the pandemic may lead to loss of lives.

Read below the points highlighted in Ogbuagu’s series of Tweets:


Let’s dispel some rumors especially because misinformation about COVID-19 may and can cost lives. Enough already!

Vaccine efficacy results are real. They were not delayed to hurt or help any politician.

The Pfizer vaccine doesn’t contain the SARS CoV-2 virus or parts of it!

No nefarious or sinister plan to inject people with a labeling code. The mRNA vaccine is not integrated into recipient’s genome.

No fetal tissue is used for the mRNA vaccine.

And No!…researchers such as myself are not part of any conspiracies.

We just want to apply science to improve patient outcomes and even better, to prevent disease.

We can only work our way out of this pandemic through effective vaccines especially because it is difficult to achieve optimal mask-wearing and physical distancing to end the pandemic.

Think of how vaccines have made deadly diseases either go away (smallpox) or become relatively rare (such as measles).

When the “COVID” vaccine becomes available, let’s roll up our sleeves and let’s end this thing!

Another challenge would be the equitable distribution of vaccines.

High vs. low/middle-income countries, and even in developed nations, to ensure that vulnerable and underserved populations, disproportionally affected by the pandemic are proportionally reached!

Now is time for strategic distribution plans at global, national, and community level.

 

 

 

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 Bio-

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!”