Covid: MHRA approves new Covid vaccine Valneva – ‘adverse reactions’ reported

Valneva ships first doses of COVID-19 vaccine on April 6th

We use your sign-up to provide content in ways you’ve consented to and to improve our understanding of you. This may include adverts from us and 3rd parties based on our understanding. You can unsubscribe at any time. More info

The sixth Covid vaccine is also the first whole-virus inactive Covid vaccine to gain regulatory approval in the UK. This is where the virus is grown in a laboratory and then made completely inactive. Doctor June Raine, MHRA Chief Executive, said: “Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine.” Co-signed by the Commission on Human Medicines, the chair of the body, Professor Sir Munir Pirmohamed said: “We have advised that the benefit risk balance is positive.”

As with any medicines available to the public, there are reactions that could happen.

The MHRA reported on the “undesirable effects” Valneva could lead to (based on current research).

In an ongoing phase III randomised study conducted in the UK, 4,000 healthy adults were divided into two cohorts.

About 1,000 people were less than 30 years of age while 3,000 adults were aged 30 or older.

In total, 3,037 participants received the Covid Valneva vaccine and 995 received the Oxford AstraZeneca vaccine (now known as Vaxzevria).

Most frequently, “adverse reactions” included:

  • Injection site tenderness (60 percent)
  • Injection site pain (40 percent)
  • Fatigue (50 percent)
  • Muscle pain (30 percent)
  • Nausea/vomiting (10 percent).

Other adverse reactions included: headaches, diarrhoea, abdominal pain, a rash, and swelling at the injection site.

Affecting up to one in 100 people, thereby considered “uncommon”, side effects might include:

  • Enlarged lymph nodes
  • Dizziness
  • Deep unresponsiveness (lethargy)
  • Decreased or abnormal sensation of skin (for example pins and needles)
  • Taste disturbance
  • Diarrhoea
  • Belly pain
  • Chills
  • Excessive sweating
  • Rash
  • Pain in leg or arm
  • Joint pain
  • Muscle cramps.

“The majority of adverse reactions were mild and resolved within two days of vaccination,” the MHRA noted.

“The incidence and severity of adverse reactions were similar after the first and second doses.”

Valneva “appeared less reactogenic than Vaxzevria [the Oxford AstraZeneca vaccine]” in participants aged 30 and older.

The new Covid vaccine, Valneva, is given intramuscularly in two 0.5ml doses, with the second dose administered at least 28 days after the first dose.

There is no data as of yet about the interchangeability of Valneva with other Covid vaccines.

To complete the Covid vaccine course, people will need two doses of Valneva.

The safety and immunogenicity of Valneva in children and adolescents has not yet been established.

Moreover, the safety and immunogenicity of Valneva has not specifically been established in older adults over the age of 65.

It’s for this reason the MHRA has approved Valneva for people between the ages of 18 to 50 years old only.

It is also unknown whether the Covid vaccine is excreted in human milk in breastfeeding mothers.

As for fertility, animal studies do not indicate that Valneva causes harmful effects.

The MHRA stated: “If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.”

Source: Read Full Article