Euro Roundup: EMA, Swissmedic recommend bivalent COVID vaccines

RoundupsRoundups | 01 September 2022 |  By 

Bivalent COVID-19 vaccines targeting the Omicron BA.1 subvariant developed by Pfizer-BioNTech and Moderna will soon be available in the EU, following a positive recommendation by a European Medicines Agency’s (EMA) committee.
“Today's positive opinions by the European Medicines Agency on the first two variant-adapted mRNA vaccines, from BioNTech-Pfizer and Moderna, are important to protect Europeans against the likely risk of autumn and winter waves of infections. We need to be ready to face another winter with COVID-19,” said European Commissioner for Health and Food Safety Stella Kyriakides.
The recommendation follows an extraordinary meeting of EMA’s Committee for Medicinal Products for Human Use (CHMP) on Thursday. Both vaccines were recommended for use in individuals ages 12 and older and both contain components of the original strain of SARS-CoV-2 and the Omicron BA.1 subvariant. While European regulators have opted for modified vaccines containing the BA.1 subvariant, the US Food and Drug Administration (FDA) has authorized updated vaccines targeting the BA.4/5 subvariant.
To reach its decision, CHMP reviewed clinical data for both vaccines. Two studies were submitted in support of the Pfizer-BioNTech vaccine Comirnaty Original/Omicron BA.1. One of the studies found that the bivalent vaccine elicited a stronger immune response in individuals ages 55 and older who received three doses of the original Comirnaty vaccine than in those who received a second booster dose of the original vaccine. EMA notes that the study included more than 1,800 participants, 300 of whom received the updated vaccine in its final composition. The other study looked at 600 participants between 18-55 years of age who received a monovalent booster containing only the Omicron BA.1 component.
 For Moderna’s updated Spikevax vaccine, the committee reviewed one study that involved more than 800 adult participants. “The study found that a booster dose of Spikevax bivalent Original/Omicron BA.1 induced a stronger immune response against the SARS-CoV-2 strain and the Omicron subvariant BA.1 compared with a booster dose of the original Spikevax vaccine,” EMA said.
The agency notes that the original versions of each vaccine will remain available for use as a primary series. Kyriakides said the European Commission will accelerate its decision to authorize the vaccines.
Moderna wins first approval for bivalent COVID-19 booster vaccine in Switzerland
Moderna is first company to win approval for a bivalent COVID-19 booster vaccine in Switzerland. The temporary authorization of the vaccine, mRNA-1273.214, follows clinical trials that found it produces a stronger immune response against Omicron subvariants than the original Spikevax.
“Compared to the original vaccine, trials have shown that this produces a stronger immune response against the Omicron variants BA.1 and BA.4/5. The protective effect of the bivalent vaccine against the original SARS-CoV-2 virus (Wuhan type) measured in the antibody concentration is equivalent to the effect of the original vaccine,” the Swiss Agency for Therapeutic Products (Swissmedic) wrote.
The side effect profile of the bivalent vaccine was similar to that seen after the administration of the second, 100 microgram dose in the primary series of Spikevax and the 50 microgram booster shot of the original vaccine, according to Swissmedic. No new safety signals were found. As such, Swissmedic and the external Human Medicines Expert Committee found the vaccine meets the Swiss safety, efficacy and quality requirements.
Swissmedic is requiring Moderna to provide it with ongoing information about the safety, efficacy and quality of the bivalent vaccine, as it does for all new medicinal products that come to market. The agency is also continuing to monitor the benefits and risks of COVID-19 vaccines in general.
How mRNA-1273.214 is used in Switzerland will depend on the recommendations now being drawn up by the Federal Commission for Vaccination and the Federal Office of Public Health. The fall vaccination program could also feature Pfizer’s bivalent Omicron vaccine. Swissmedic is conducting a rolling review of an application to extend the authorization of Pfizer’s original COVID-19 vaccine Comirnaty to cover its bivalent successor.
Swissmedic Notice
France’s ANSM authorizes production of drug delivery device under old directive
The French National Agency for the Safety of Medicines and Health Products (ANSM) has authorized a company to manufacture a drug delivery device under the old directive to mitigate a product shortage.
In July, ANSM learnt of a shortage of the cannulas used to administer diazepam intrarectally in infants and children for the treatment of seizures. The shortage follows the decision to stop production of the drug delivery device on 26 May 2021, the day the Medical Device Regulation (MDR) transition period ended, and the new, more stringent requirements became fully applicable.
Given the shortage of rectal cannulas, ANSM is authorizing the manufacturer to resume production of the devices under the old standards. The action will temporarily spare the manufacturer from the need to meet the MDR requirements when making the device, with the old Medical Devices Directive applying instead. ANSM is also looking into other sources of supply.
To mitigate the near-term impact of the device shortage, ANSM is advising healthcare professionals to use midazolam instead of diazepam. Midazolam, which is given orally, is authorized for the treatment of seizures in infants aged three months and up, although it can only be used in hospitals in children aged under six months.
When use of midazolam is not possible, ANSM is recommending that diazepam is given intrarectally by syringe without a cannula. If that route of administration is deemed too complicated or risky, ANSM is recommending the oral administration of diazepam, using a syringe to deliver the drug between the gum and the cheek.
ANSM Notice (French)
MHRA approves Novavax’s COVID-19 vaccine for use in children aged 12 to 17 years
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Novavax’s COVID-19 vaccine Nuvaxovid for use in children aged 12 to 17 years. MHRA granted an extension to the existing approval after reviewing Novavax’s safety, quality and effectiveness data on the vaccine.
Novavax received authorization for the vaccine in people aged 18 years and older on 3 February. Late last week, MHRA approved an extension to clear the adjuvanted protein vaccine for use in younger people via the European Commission Decision Reliance Route.
The reliance route, which took effect on 1 January 2021 and will apply for two years, allows the UK regulator to rely on a European Commission approval decision when determining an application for a Great Britain Marketing Authorisation. MHRA aims to determine the Great Britain MA as soon as possible after the EU approval. Novavax disclosed the EU label extension on 5 July.
As it stands, the MHRA extension is unlikely to impact the UK vaccination program. MHRA said the UK is yet to deploy Nuvaxovid in its COVID-19 vaccination program, although the fall schedule lists the Novavax jab as being eligible for use in adults in “exceptional circumstances.” Pfizer and BioNTech’s Comirnaty is currently the only vaccine on the fall booster program for children aged five to 17 years.
MHRA Notice
EMA updates guidebook for tenderers to clarify openness to international organizations
The European Medicines Agency (EMA) has updated its guidebook on submitting tenders in response to procurement requests. EMA’s revisions include a clarification about the eligibility of international groups to participate in procurement procedures.
In the latest version of the guidebook, EMA has added the statement: “Participation in procurement procedures is also open to international organizations as defined in article 156(1) of the general Financial Regulation.” Article 156(1) allows the Commission to “implement the budget indirectly with international public-sector organisations set up by international agreements (‘international organisations’) and with specialised agencies set up by such organisations.”
EMA has inserted the statement between existing sections that state tendering procedures are open to organizations “in a third country which has a special agreement with Union in the field of public procurement” and that it can accept offers to sign contracts with tenderers from “any other country which has an international agreement with the Union in the field of public procurement.”
EMA Guidebook
Hikma recalls injectable medicines from the UK after out of specification result
Hikma Pharmaceuticals USA is recalling five batches of the unlicensed medicine lorazepam from the UK because of an out of specification result with related substances during testing for retain samples.
In light of the out of specification result, MHRA has asked healthcare professionals to stop supplying the affected batches immediately and quarantine all remaining stock. The agency has categorized the event as a Class 2 recall.
MHRA allowed the importation of the unlicensed medicine into the UK “to meet the special need of individual patients.” Lorazepam injections are used for uncomfortable or prolonged investigations, such as bronchoscopy, to treat acute anxiety states and for the control of status epilepticus, seizures that last too long or occur close together.
MHRA Notice
Other News:
Swissmedic has published its hemovigilance annual report for 2021. The report covers the safety of blood transfusions in Switzerland. Swissmedic saw an increase in transfusions in 2021 compared to the COVID-19-affected 2020, with figures comparable to those seen in the year before the pandemic. The agency cited the backlog of elective procedures from the previous year as a potential explanation for the trend. Swissmedic Report


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