Oxford University/AstraZeneca Covid-19 vaccine approved

 

The COVID-19 vaccine developed by Oxford University/AstraZeneca has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required safety, quality and effectiveness standards.

Following a rigorous, detailed scientific review by the MHRA’s expert scientists and clinicians and on the basis of the advice of its scientific, independent advisory body, the Commission on Human Medicines, the UK regulator has approved COVID-19 Vaccine AstraZeneca for use across the UK. 

MHRA Chief Executive Dr June Raine said:

“We are delighted to announce the good news that the Oxford University/AstraZeneca vaccine for COVID-19 is now approved for supply following a robust and thorough assessment of all the available data.

“A huge collaborative effort and commitment goes into these assessments which include reviewing vast amounts of data. Our staff have worked tirelessly to ensure we continue to make safe vaccines available to people across the UK. 

“No stone is left unturned when it comes to our assessments. This approval means more people can be protected against this virus and will help save lives. This is another significant milestone in the fight against this virus. We will continue to support and work across the healthcare system to ensure that COVID-19 vaccines are rolled out safely across the UK. Protecting health and improving lives is our mission and what we strive for.

The Oxford University/AstraZeneca vaccine has been approved for use for people 18 years or older and consists of two doses, with the second dose administered 4-12 weeks after the first dose. The transportation and storage requirements for this vaccine mean that it needs to be kept at temperatures of 2C to 8C, which is similar to a conventional fridge for up to six months and can be administered within existing healthcare settings.

Oxford/AstraZeneca has been submitting data to the MHRA since September 2020 under the rolling review process, enabling data to be reviewed in stages, as it became available. 

The National Institute for Biological Standards and Control part of the MHRA, has been and will continue doing, independent laboratory testing to ensure that every batch of the vaccine meets the expected standards of safety and quality.

As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring by the MHRA and that the benefits in protecting people against COVID-19 must be greater than any side-effect or potential risks.

Additional updates relating to use of the Pfizer/BioNTech vaccine

The Commission on Human Medicines (CHM) has also reviewed further data for the Pfizer/BioNTech vaccine as it has become available and has recommended the following changes:

• Pregnancy and women who are breastfeeding - the 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. This advice is in line with pregnancy and breastfeeding advice for the Oxford University/AstraZeneca vaccine
• Allergies - 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 now have the vaccine.

• Dosage interval - the advice has been updated to say that the second dose of the Pfizer vaccine should be given at least 21 days after the first dose.

 

Notes to Editor

HIV 'Superinfection' Boosts Immune Response: Findings May Provide Insight Into HIV-Vaccine Development

 Women who have been infected by two different strains of HIV from two different sexual partners -- a condition known as HIV superinfection -- have more potent antibody responses that block the replication of the virus compared to women who've only been infected once.

These findings, by researchers at Fred Hutchinson Cancer Research Center in Seattle, are published online March 29 in PLoS Pathogens.
"We found that women who had been infected twice not only had more potent antibody responses, but some of these women had 'elite' antibody activity, meaning that they had a broad and potent ability to neutralize a wide variety of strains of HIV over a sustained period time," said senior author Julie Overbaugh, Ph.D., a member of the Hutchinson Center's Human Biology Division. It is estimated that only about 1 percent of people with HIV are so-called "elite neutralizers" who are able to potently neutralize multiple subtypes of the virus.
"Individuals who become superinfected with a second virus from a different partner represent a unique opportunity for studying the antibody response and may provide insights into the process of developing broad neutralizing antibodies that could inform HIV-vaccine design," she said.
The study suggests that harboring a mixture of different viral strains may be one way to promote a robust antibody response. The findings also suggest that being infected with two different HIV strains not only leads to a strong response, but also a more rapid response that is capable of recognizing many other HIV strains.
The researchers tracked the immune activity of 12 superinfected women from Mombasa, Kenya, over a five-year period and compared each to a control group of three singly infected women. Overbaugh and lead author Valerie Cortez, a doctoral student in her lab, assessed the ability of antibodies present in superinfected and singly infected women to neutralize a spectrum of circulating HIV-1 variants. In doing so they were able to determine whether the presence of two viruses compared to one made a difference in immune response. The researchers controlled for variables such as antibody response prior to superinfection and biomarkers of immunity such as CD4+ T cell count and viral load. The study found that superinfected women had, on average, 1.68 times more neutralizing antibodies than non-superinfected women, and they scored much higher in their ability to neutralize the virus -- superinfected women had 1.46 times greater potency than the singly infected women.
More than 1.1 million Americans are estimated to be living with HIV today, and every nine-and-a-half minutes someone in the U.S. becomes infected, according to the U.S. Department of Health and Human Services. An HIV vaccine is considered the best approach to long-term protection from HIV infection, but attempts to develop such a vaccine so far have meet with limited success.
"The holy grail of an HIV vaccine is to elicit antibodies to the virus because antibodies have been shown to block virus infection. But there has been little progress in determining how to elicit such antibodies with a vaccine. The study of individuals HIV infected who have developed strong antibody responses to the virus may shed light on the best approach to design a vaccine that will induce an effective immune response," Overbaugh said.

**Published in "SCIENCE DAILY"