The COVID-19 vaccine developed by
Moderna has today been given regulatory approval for supply by the Medicines
and Healthcare products Regulatory Agency (MHRA). This follows a thorough and
rigorous assessment by the MHRA’s teams of scientists, including advice from
the independent Commission
on Human Medicines, which reviewed in depth all the data to ensure this
vaccine meets the required standards of safety, quality and effectiveness.
This is the third COVID-19 vaccine to be
approved for use by the MHRA and is the second mRNA vaccine (the Pfizer/BioNTech
vaccine approved in December 2020 is also an mRNA vaccine).
MHRA Chief Executive Dr June Raine said:
“Today’s approval brings more encouraging news to the public
and the healthcare sector. Having a third COVID-19 vaccine approved for supply
following a robust and thorough assessment of all the available data is an
important goal to have achieved and I am proud that the agency has helped to
make this a reality.
“The progress we are now making for
vaccines on the regulatory front, whilst not cutting any corners, is helping in
our global fight against this disease and ultimately helping to save lives. I
want to echo that our goal is always to put the protection of the public first.
“Once in use, all COVID-19 vaccines are continually monitored by the MHRA.
This ensures that the benefits in protecting people against COVID-19 continue
to far outweigh any potential side-effects.
“Meantime, even if you have had a
vaccine it is vital that everyone follows the national lockdown restrictions
and remembers ‘stay alert, protect the NHS and save lives’ at all times.”
Professor Sir Munir Pirmohamed, Chair of
the Expert Working Group of the Independent Commission on Human Medicines said:
“We are delighted to be able to give a
positive recommendation for the Moderna vaccine which will help in the roll-out
of the COVID-19 vaccination programme.
“As with all the COVID-19 vaccine data
we have seen to date, we have ensured a robust and thorough safety assessment
has been carried out with the independent experts that sit on this group.”
Vaccine Background
This Moderna vaccine works by injecting
a small part of the COVID-19 virus’ genetic code, which triggers an immune
response and creates antibodies in the human body able to fight the virus. The
dosage for this specific vaccine requires two doses to be given. It is
recommended to administer the second dose 28 days after the first. It is
approved for use in people 18 years and over, and it can be used by pregnant
and breastfeeding women following a discussion with their healthcare provider
on the benefits and risks. It can be stored at -20°C for up to six months.
The
National Institute for Biological Standards and Control, part of the
agency, is carrying out independent batch release on all of the approved
vaccines, to ensure that every batch meets quality standards, and it will do so
for the Moderna COVID-19 Vaccine.
In line with the other COVID-19 vaccines
that have been approved, the Moderna vaccine should only be considered for use
in pregnancy when the potential benefits outweigh any potential risks for the
mother and baby. Women should discuss the benefits and risks of having the
vaccine with their healthcare professional and reach a joint decision based on
individual circumstances. Women who are breastfeeding can also be given the
vaccine after a discussion with their healthcare professional.
Anyone with a previous history
of allergic reactions to the ingredients of the vaccine should not receive it,
but those with any other allergies such as a food allergy can have the vaccine.
No comments:
Post a Comment