Pharmaceutical Market Europe • April 2023 • 10
CORONAVIRUS NEWS
FDA authorises first at-home COVID-19 and flu test for emergency use
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to the first at-home over-the-counter diagnostic test that can be used to detect both influenza and COVID-19 viruses.
The Lucira COVID-19 & Flu Home Test is indicated for those who have signs and symptoms that are consistent with a respiratory tract infection, including COVID-19, and can be purchased without a prescription.
The single-use test uses self-collected nasal swab samples and provides results in about 30 minutes, the agency said, with diagnoses able to differentiate between both influenza A and B viruses.
In a statement, the FDA also outlined that all results should be reported to healthcare providers for public health reporting and to ensure patients receive appropriate medical care.
The decision is supported by results that showed the test correctly identified 99.3% of negative and 90.1% of positive influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative influenza B samples in symptomatic individuals.
Since there are currently not enough cases of influenza B circulating to include in a clinical study, the EUA requires Lucira Health to continue to collect samples to study the test’s ability to detect the virus in real-world settings.
Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children
Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine has been authorised by the US Food and Drug Administration (FDA) for emergency use as a single booster dose for certain young children.
With this latest approval, children aged six months to four years who have completed their primary series with three doses of the companies’ original vaccine will be able to receive a 3µg booster dose of the bivalent vaccine after at least two months.
The vaccine is already authorised as the third dose of the three-dose primary series in this age group, but a booster dose is not authorised for these children at this time.
The partners have previously maintained that a fourth dose would ‘give families the option to further protect their young children against more recently circulating Omicron sub-lineages’.
The FDA’s expanded authorisation was supported by data showing a fourth dose of the bivalent booster elicited a higher Omicron BA.4/BA.5 neutralising response in children aged six months to four years, compared to those who received three doses of the companies’ original vaccine.
The safety and tolerability profile of the bivalent vaccine was similar to that of the original vaccine, the companies stated.
JCVI recommends spring COVID-19 booster for those at highest risk
The Joint Committee on Vaccination and Immunisation (JCVI) has advised the UK government that those at the highest risk of severe COVID-19 should be offered an extra booster vaccination this spring.
This includes adults aged 75 years and over, residents in care homes for older adults, and individuals aged five years and over who are immunosuppressed. Those eligible will be offered the booster around six months after their previous dose.
Included in its advice, the JCVI recommends that vaccines from Pfizer/BioNTech, Moderna, Sanofi/GSK and Novavax can be used for the spring programme.
As with previous campaigns, the vaccine offered will depend on a person’s age and local supply considerations, with all eligible children aged under 12 years to be offered a children’s formulation of the Pfizer/BioNTech vaccine.
The committee has already advised that an autumn booster should be given to those at a higher risk of severe COVID-19, with a spring booster intended to bridge the gap between the two programmes and allow those who are most vulnerable to be well protected throughout the summer.
The advice represents the JCVI’s new scaled-back approach for future vaccination campaigns, prioritising boosters only for those considered to be at risk of serious illness.