“The government today accepted the recommendation of the Independent Medicines and Health Products Regulatory Agency (MHRA) to approve Pfizer / BioNTech’s Covid-19 vaccine for use,” a spokesperson for the Department of Health and Social Affairs to the Press Association of Britain. The spokesperson said the emergency use authorization followed “months of rigorous clinical trials and extensive data analysis by MHRA experts who concluded the vaccine met its strict standards. of safety, quality and efficiency ”.
In accordance withUK frontline healthcare workers, residents of nursing homes, the very elderly and those with underlying illnesses that make them particularly vulnerable to complications from COVID-19 are expected to receive the first doses of the vaccine. Pfizer’s vaccine, like the Oxford and Moderna formulas, requires two doses about a month apart.
UK Health Secretary Matt Hancock called “fantastic news” that the UK regulator has deemed the first vaccine safe and has promised distribution will start from Monday. He told the BBC Breakfast show that vaccinations “will start with older people and people in nursing homes.”
Prime Minister Boris Johnson also welcomed the news, confirming in a tweet his intention to start rolling out doses from next week.
“It’s the protection of vaccines that will ultimately allow us to get our lives back and get the economy going,” Johnson said.
Hancock, the UK’s top public health official, notedthe Pfizer vaccine, which is to be stored at around -94 degrees Fahrenheit, but said Britain will receive its first 800,000 doses next week. The UK has ordered a total of 40 million doses of the Pfizer vaccine, enough to treat 20 million people.
Two other vaccines, one developed by the American company, which also requires below zero storage, and one made by a UK pharmaceutical company University, have also applied for emergency use authorization in the United States and Europe.
Pfizer and Moderna both said data from large-scale human trials, involving tens of thousands of people, showed their vaccines to be around 95% effective in preventing COVID-19 infection. AstraZeneca / Oxford found that their vaccine, which works in a different way, was up to 90% effective with a certain dosing schedule. The vaccine developed by Oxford is much cheaper to produce and distribute because it only requires storage at refrigerator temperature.
“This is the first emergency use authorization after a global Phase 3 trial of a vaccine to help fight the pandemic,” Pfizer and BioNTech said on Wednesday in a joint statement, adding that they “Anticipated new regulatory decisions around the world in the future. days and weeks and are ready to administer doses of vaccine after possible authorizations or regulatory approvals.
Pfizer chief executive Albert Bourla called the UK decision a “historic moment in the fight against COVID-19”.
None of the human trials with any of the three major western-made vaccines revealed significant adverse effects. Some side effects commonly associated with long-used vaccines, including injection site pain, fatigue, and headache, were observed in the trial data.
In China and Russia, officials have been administering thousands of doses of COVID-19 vaccines developed by government-backed research institutes for weeks, outside of trials. Unlike Western immunization programs, neither Russia nor China conducted large-scale international human trials with data provided for independent analysis before they began their non-experimental vaccine programs.
Trust and “infodemic”
Logistical issues aside, epidemiologists and public health officials around the world have warned that another major hurdle in putting the coronavirus pandemic behind humanity could be distrust of the vaccines that become available. .
On Saturday, the World Health Organization warned that an “infodemic” sweeping through social media threatened to leave humanity at the mercy of the novel coronavirus, which has killed more than 1.5 million people worldwide and near of 271,000 in the United States alone.
“Coronavirus disease is the first pandemic in history in which technology and social media are used on a large scale to keep people safe, informed, productive and connected,” the WHO said in a statement. “At the same time, the technology we rely on to stay connected and informed is enabling and amplifying an infodemic that continues to undermine the global response and jeopardize pandemic control measures. ”
The WHO suggested that both online platforms and politicians and other influential figures were making “deliberate attempts to disseminate misinformation”, which sowed distrust of scientific and health institutions.
“Without the proper trust and the correct information, diagnostic tests are not used, vaccination campaigns (or campaigns to promote effective vaccines) will not achieve their goals, and the virus will continue to grow,” he said. warned WHO.
Aconducted in early September revealed growing skepticism about developing coronavirus vaccines, with most voters saying that if a vaccine was made available this year, their first thought would be that it was rushed without sufficient testing.
Only 21% of voters nationwide said in the survey that they would receive a vaccine as soon as possible if it was available free of charge, which was down from 32% in a survey conducted in late July. Most said they would think about it, but were waiting to see what happened to others before getting one themselves.
This pandemic has seen drug companies and research institutes working with governments and independent regulators to compress the generally years-long process of vaccine development and approval into a much shorter time frame.
The pace has been completely unprecedented, but the entities involved, as well as outside experts in infectious disease and vaccinology, have insisted throughout that the process is safely compressed, in large part by steps that overlap. normally overlap sequentially, rather than eliminating steps in the process. testing and certification process.
Hancock, the UK government’s health chief, told UK broadcaster Piers Morgan on Wednesday that if they could get it approved even though they were not in a high-risk group, he would be happy to go. get vaccinated live on TV next week with Morgan showing it off. his confidence in the vaccine.