The UK on Wednesday became the first country in the world to grant permission for emergency usage of the Pfizer-BioNTech vaccine against the novel coronavirus, which has brought world systems to their knees since its emergence in China's Wuhan last year.
While the announcement of winning the UK approval was greeted as fantastic news by many, including UK prime minister Boris Johnson " who himself is a COVID survivor " as well as Pfizer and its German partner BioNtech, questions were also raised by the European Union lawmakers over the decision.
Pfizer's vaccine is still awaiting a nod from regulators in the US and Europe and decisions in this regard are expected later in December, as per reports.
'Fanatastic news,' says Johnson
Announcing the news on Twitter, Johnson said that it was "fantastic" that the Medicines and Healthcare Products Regulatory Agency (MHRA) had given formal approval and said that the vaccine will be made available across the UK from next week.
"It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again," Johnson said.
It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again. (2/2)
" Boris Johnson (@BorisJohnson) December 2, 2020
British Health Secretary Matt Hancock said he was "absolutely thrilled" at the news and very proud that the UK is the first country in the world to have a "clinically authorised vaccine" and extended thanks to scientists, Pfizer and his team.
Hancock said Britain expects to begin receiving the first shipment of 8 lakh doses "within days", and people will begin receiving shots as soon as the National Health Service gets the vaccine.
Giving information about the rollout process, he told BBC that the two-shot vaccine will first be administered to those most vulnerable and it will save lives.
"And then once we have started to protect the most vulnerable, it will help us all get back to normal," he said.
According to news agency AP, Hancock said told the broadcaster that help is on its way and that the situation would start to improve in the spring.
However, he also cautioned that "between now and then, we've got to hold on, we've got to hold our resolve".
Earlier, during a vote in the Parliament on new regional curbs in the UK after its exit from a lockdown, Johnson also warned against relaxing guard, especially during winter.
"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," news agency AFP quoted him as telling lawmakers before the vote.
Director-General of the World Health Organisation Tedros Adhanom Ghebreyesus also shared the news on Twitter while British MP Priti Patel thanked Hancock and the government team.
The UK🇬🇧 has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine for widespread use.
" Priti Patel (@pritipatel) December 2, 2020
According to news agency AFP, scientists also acclaimed the UK news but cautioned that logistical challenges remained. The Pfizer-BioNTech jab has to be stored at -70 degrees Celsius (-94 degrees Fahrenheit), requiring specialist freezers. It requires two doses 21 days apart, and the MHRA said immunity kicks in a week after the second dose.
"It's not easy but we've got those plans in place," Hancock said.
The news agency reported that campaigners and governments have stepped up calls to ensure poorer countries enjoy equal access to successful vaccines.
The Women's Equality Party in the UK also hailed the approval as a scientific triumph and sought to draw attention to groups it said must be pioritised.
The approval of the Pfizer vaccine is fantastic news & a scientific triumph. Residents & workers in #CareHomes must be prioritised, alongside other health and care workers. Govt must also prioritise low paid workers in other high risk and essential jobs - many of whom are women.
" Women's Equality Party (@WEP_UK) December 2, 2020
Meanwhile, the UK government in a statement, said that the Joint Committee on Vaccinations and Immunisations (JCVI) will soon make public its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
The statement also said that the approval on Wednesday "follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality, and effectiveness".
Historic moment in fight against COVID-19, says Pfizer
As per news agency AFP, Pfizer chief executive Albert Bourla termed the UK certification was a "historic moment in the fight against COVID-19".
"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.
US giant Pfizer and German newcomer BioNTech further said that they expected further regulatory decisions from other countries "in the coming days and weeks".
According to news agency AP, the shots made by German company BioNTech and US-based Pfizer were tested on tens of thousands of people. And while that study isn't complete, early results suggest the vaccine is 95 percent effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who'd received the actual vaccine and the rest had gotten a dummy shot.
The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.
Final testing is yet to be completed and it remains to be determined whether or not the Pfizer-BioNTech shots would protect against people spreading the coronavirus without showing symptoms. Another question is how long the protection lasts.
The vaccine also has been tested in only a small number of children, none younger than 12, and there's no information on its effects in pregnant women.
European lawmakers raise questions, UK regulator says no corners cut
Outside the UK, the decision has met with criticism. Peter Liese, an EU lawmaker and a member of Angela Merkel's party, in a statement called the decision problematic and said the process followed by the European regulator European Medicines Agency was better.
"I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way. A few weeks of thorough examination by the European Medicines Agency (EMA) is better than a hasty emergency marketing authorisation of a vaccine," he said.
Liese also alleged that the decision to grant approval was an attempt to distract attention from the failure of the Johnson government in tackling the coronavirus crisis and stressed that the decision had nothing to do with Brexit.
Indian researcher Anant Bhan also sounded a cautionary note, saying that the UK approval will put pressure on other regulators to make decisions on a priority basis but the "fundamentals of science and pharmacovigilance should be followed even during a pandemic".
"We also have to understand the implications for the ongoing Pfizer mRNA vaccine clinical trial (which had a longer follow-up designed) as well as other vaccine candidate clinical trials ongoing in the UK (and indeed other countries)," he said.
Important to keep tabs on safety, and effectiveness when deployed at the population level. Transparency will continue to be required. Extra-ordinary times, but the fundamentals of science, and pharmacovigilance should be followed even during a pandemic.
" Anant Bhan (@AnantBhan) December 2, 2020
This will of course put pressure on other regulatory agencies to make decisions also on a priority basis. The UK MHRA has made a decision in around a week's time since Pfizer put in the regulatory submission asking for EUA.
" Anant Bhan (@AnantBhan) December 2, 2020
The researcher however lauded the MRHA for proactively building confidence in its processes.
The UK regulator, however, asserted that no corners had been cut during its process to give the green signal to the vaccine candidate.
MHRA chief executive June Raine, at a press conference, said that MHRA's "rigorous assessments" of the jab began in June after interim results from early trials of Pfizer and BioNTech became available, reported AFP.
Overlapping trials and "rolling reviews" since June to reach the determination in record time, the independent regulator said, adding: "That doesn't mean any corners have been cut " none at all. The safety of the public will always come first."
"If you climb a mountain, you prepare and prepare," Raine said. "On 10 November we were at base camp. When we got the final analysis we were ready for that last sprint that takes us to today."
Storm over Hancock's Brexit remarks
Hancock earlier on Wednesday argued that Brexit has helped Britain accelerate the rollout of the vaccine while the European Union lags on its own approval.
"Whilst until earlier this year we were in the European Medicines Agency (EMA), because of Brexit we've been able to make a decision to do this based on the UK regulator, a world-class regulator," Hancock told Times radio.
As a result, Britain was able to "not go at the pace of the Europeans, who are moving a little bit more slowly," he said.
Britain formally quit the EU in January, and the EMA has relocated from London to Amsterdam. But the country remains in a post-Brexit transition period until the end of this year, and EU pharmaceutical regulations still apply for now.
The MHRA has taken a more nuanced view in this regard with its chief executive stating: "We have been able to announce the supply of this vaccine using provisions under EU law which exists until 1 January."
UK parliamentarian Alok Sharma also lauded the approval, hailing it as a national victory of the UK. However, Andreas Michaelis, the German Ambassador to the UK took exception to the remark, and stressed how "cross border cooperation was crucial in defeating the virus".
Covid BioNTech/Pfizer vaccine approved for use next week in UK. Fantastic news. Was always convinced that cross border cooperation was crucial in defeating the virus. A German/US vaccine approved in the UK for the 1st time: this is not a national thing. https://t.co/78xvJKmVCx
" Andreas Michaelis (@GermanAmbUK) December 2, 2020
Why is it so difficult to recognize this important step forward as a great international effort and success. I really don't think this is a national story. In spite of the German company BioNTech having made a crucial contribution this is European and transatlantic. https://t.co/SE4XDG4P0o
" Andreas Michaelis (@GermanAmbUK) December 2, 2020
Meanwhile, the EMA, according to a Reuters report, has slammed the UK decision stating that its "longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain".
Earlier, the EMA had said that it would hold an extraordinary meeting on 29 December "at the latest" to consider its own emergency approval for the vaccine developed by Germany's BioNTech and US giant Pfizer.
The Eu agency had also stressed Tuesday that all rules and processes have to be followed to grant approval to vaccines, even during a public health emergency,
"What is different for COVID-19 vaccines is that speed of development and potential approval is much faster due to the public health emergency," it noted. But even that pressing need cannot overcome the rules.
"Before approval, all vaccines in the European Union are evaluated against the same high standards as any other medicine," the EMA said in a statement.
With inputs from agencies