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The Pfizer / BioNTech coronavirus vaccine has been approved in the UK. Photo / AP
The UK-approved Pfizer / BioNTech coronavirus vaccine requires four weeks from the first puncture to achieve the “best immunity,” the regulators behind the decision said.
In the meantime, those who are the first to receive the vaccine will be invited to participate in a voluntary “Yellow Card” side effect monitoring program.
On Wednesday, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) became the first in the world to approve a Covid-19 vaccine for widespread use with the first doses to be delivered within days.
Executive Director Dr. June Raine insisted that no corners had been cut in the approval process and assured the public that a decision had been made after an “extremely thorough and scientifically rigorous review” of safety, efficacy and quality of the vaccine.
“The safety of the public will always come first,” he said, adding that the MHRA had completed a “continuous review” to achieve approval in the shortest time possible.
She described the process as climbing a mountain that began in June.
“By the time the interim results came in in November, we were at base camp,” Raine said, describing the final leg as a “sprint.”
Australian Health Minister Greg Hunt said Australia could follow suit in March if the Therapeutics Administration approves the jab.
Professor Sir Munir Pirmohamed said immunization will require two doses 21 days apart.
While “some immunity” is seen 12 days after the first dose, the “best immunity” comes seven days after the second dose, meaning it will take a total of four weeks before people can consider themselves themselves safe from the virus.
Raine thanked those who had signed up for the clinical trials and said they will now “invite the public to join us in an active monitoring program” to look for possible side effects.
The monitoring will be based on the existing yellow card system in the UK which allows people to report the side effects of any medicine or medical device. The scheme relies on voluntary reports to point out any early warning signs that may warrant further investigation.
“We do not yet know how Covid-19 interacts and behaves with the drugs or medical devices used for existing conditions,” the site warns on its Covid page.
“By reporting through this site, patients and healthcare professionals can help gather valuable evidence to inform decisions about the safe and effective use of drugs and medical devices as the pandemic evolves.”
The vaccine guide states that “most side effects are mild or moderate and disappear within a few days of appearing.”
The so-called “very common” that affect more than one in 10 people include
• pain at the injection site
• fatigue
• headache
• Muscle pain
• shaking chills
• joint pain
• fever
Other so-called “common” side effects that affect up to 1 in 10 include
• swelling at the injection site
• redness at the injection site
• nausea
While the “uncommon ones” that can affect up to 1 in 100 people include:
• enlarged lymph nodes
• Feel bad
WHO WILL GET IT FIRST?
The vaccine will be given first to people who are considered to be at higher risk of dying from the disease, including the elderly, people with pre-existing conditions, and frontline healthcare workers before a major public rollout.
That means nursing home residents will be first, followed by those over 80 and NHS workers, then those over 75, followed by those over 70 and people with conditions that make them clinically vulnerable, and so on in five-year age groups.
The next phase will consist of the deployment of the vaccine by the general public for those over 16 years of age, which will be carried out by local authorities.
However, the vaccine is “not recommended” for children under 16 years of age. Women who are pregnant or breastfeeding are also advised that there is “limited data” on their situation and to check with their GP or pharmacist.
“As a precautionary measure, you should avoid getting pregnant for at least two months after the vaccination,” the UK guide states.
People should inform their doctor or pharmacist if they are taking other medications or have recently received any other vaccines.
Launch will also be complicated by the low temperatures that the vaccine requires to remain stable, below -70 ° C.
Trials show that it remains stable at 2-8 ° C for a short period of time, however specific cold storage requirements will increase the demand for dry ice and could make delivery difficult in hot countries in the developing world.
MINISTER SAVED WITH TWEET
British Prime Minister Boris Johnson praised the “fantastic” news that could help the UK get back to normal.
“It is the protection of vaccines that will finally allow us to get our lives back and get the economy moving again,” he said.
But Business Minister Alok Sharma was widely criticized for a tweet saying: “The UK was the first country to sign an agreement with Pfizer / BioNTech, we will now be the first to implement their vaccine.
“To everyone involved in this advance: thank you.”
“For years to come, we will remember this moment as the day the UK led humanity’s charge against this disease.”
“Wtaf. The vaccine was developed by German scientists in collaboration with a US pharmaceutical company under the primary auspices of the US FDA. Stop trying to steal the glory of other people,” replied a Twitter user.
“I’m sure the Turkish-Germans who developed the vaccine and the Belgians who make it (because the packaging facility moved from the UK due to Brexit) will be surprised to find that they were actually following the great and decisive British leader Johnson , “” said another.
“Pfizer is American, BioNTech is German, the vaccine will be made in Belgium. The UK government is proud to ‘lead the charge’ by signing a check. Pathetic.”
Meanwhile, Interpol has warned of the threat of fake vaccines and stolen supplies, as criminal gangs could target those desperate for a cure for the virus.
“As governments prepare to launch vaccines, criminal organizations plan to infiltrate or disrupt supply chains,” said Juergen Stock, head of the global law enforcement agency based in Lyon, France.
“Criminal networks will also target unsuspecting members of the public through bogus websites and bogus cures, which could pose a significant risk to their health, even their lives,” he said.
“It is important to be vigilant, to be skeptical and to be safe, as offers often seem too good to be true,” the agency said.
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