Pharmaceutical Technology Editors

On August 23, 2021, FDA approved the first COVID-19 vaccine: the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty. Comirnaty is indicated for the prevention of COVID-19 disease in individuals 16 years of age and older. This vaccine will continue to be available under Emergency Use Authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

The Pfizer-BioNTech COVID-19 vaccine has been available under EUA since December 11, 2020 for individuals 16 years of age and older. On May 10, 2021, the authorization was expanded to include those 12 through 15 years of age.

Comirnaty contains messenger RNA (mRNA), which makes a mimic of one of the proteins in the virus that causes COVID-19. As a result, the immune system of the individual receiving this vaccine will react defensively to the virus that causes COVID-19. The mRNA is present in the body for a short time and is not incorporated into nor does it alter an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered in two doses that are three weeks apart.

“[FDA’s] approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met [FDA’s] rigorous scientific standards for [E]mergency [U]se [A]uthorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality [FDA] requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, in an agency press release. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the [United States].”

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release. “We have not lost sight that the COVID-19 public health crisis continues in the US and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US."

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FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech

World Health Organization (WHO) Director-General Tedros Adlhanom Ghebreyesus stated to reporters in Budapest, Hungary on August 23rd, 2021 that he wanted countries considering third vaccine doses “to share what can be used for boosters with other countries so [they] can increase their first and second vaccination coverage,” according to a report from the Associated Press.

Earlier in August, Adlhanom Ghebreyesus had called for a two-month moratorium on COVID-19 booster shots 

Various countries, including the United States and Israel, have either begun offering or plan to offer third vaccine doses. Hungary recently became the first European Union member state to allow residents to sign up for a booster shot. Currently, more than 187,000 Hungarian residents have received the booster.

Vaccine inequality was a point of emphasis for Adlhanom Ghebreyesus. He stated that while 4.8 billion vaccine doses have been delivered globally, 75% of these shots have gone to just 10 countries. Conversely, vaccine coverage across Africa is at less than 2%.

“The virus will get the chance to circulate in countries with low vaccination coverage, and the delta variant could evolve to become more virulent, and at the same time more potent variants could also emerge,” said Adlhanom Ghebreyesus in the news report.

1. Branswell, Helen. WHO calls for a temporary moratorium on administering booster shots of Covid-19 vaccines. 

https://www.statnews.com/2021/08/04/who-calls-for-a-temporary-moratorium-on-administering-booster-shots-of-covid-19-vaccines/

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

WHO Head Reiterates Call for Two-Month COVID-19 Booster Moratorium

The United Kingdom’s medicine regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds. The decision was announced in an Aug. 17, 2021 press release.

Confirming the vaccine (Spikevax) is safe and effective in adolescents, the conditional marketing authorization extension granted by the MHRA is valid for Great Britain. The approval was made via the European Commission Decision Reliance Route, which is when a marketing authorization application references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

“I am pleased to confirm that that the COVID-19 vaccine made by Moderna has now been authorized in 12–17 year olds. The vaccine is safe and effective in this age group,” said June Raine, MHRA chief executive, in the press release. “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 17-year age group. It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group should be vaccinated with the COVID-19 vaccine made by Moderna as part of the deployment program.”

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds. 

UK Regulator MHRA Approves Moderna COVID-19 Jab for Adolescents

Novartis has announced, in an Aug. 17, 2021 press release, that is has been granted further approval from the China National Medical Products Administration for its moderate-to-severe plaque psoriasis treatment, Cosentyx (secukinumab), to be used in pediatric patients who are candidates for systemic therapy or phototherapy.

With this announcement, Cosentyx is the only interleukin inhibitor approved in China for this patient population. The approval decision was made based on the results of two Phase III international studies in pediatric patients, aged 6 years to <18 years, which demonstrated that the therapy had a similar safety profile in children and adolescents as in adults.

“Psoriasis goes beyond skin symptoms. If left untreated it can become a source of embarrassment, affecting a young person’s self-esteem. The approval in China of Cosentyx means we are able to help even more children and adults around the world live their lives to the fullest, by providing them with a safe and effective therapy they can trust,” said Todd Fox, Novartis Global Medical Franchise, head of Immunology, Hepatology, and Dermatology, in the press release. “With further US and European filings for childhood arthritic conditions, we have taken another step in our ambition to expand Cosentyx to 10 indications over the next 10 years as part of our commitment to immuno-dermatology and rheumatology.”

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

Novartis Secures Chinese Approval for Pediatric Indication of Cosentyx

The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report setting out recommendations on how regulators should address the issues that the use of artificial intelligence (AI) poses to global medicines regulation.

To formulate the recommendations, the ICMRA Informal Network for Innovation working group employed a horizon-scanning exercise in AI and the work was led by the European Medicines Agency (EMA). Two hypothetical case studies were developed and then used to ‘stress test’ the regulatory systems of ICMRA members to see where changes may be required.

Based on the work, key issues relating to the regulation of future therapies using AI were identified and recommendations were developed by the group to foster the uptake of AI. Some of the main findings were that, when assessing and regulating AI, it may be necessary for regulators to apply a risk-based approach; strengthened governance structures should be established by stakeholders for the oversight of algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product; and that regulatory guidelines should be developed in areas such as data provenance, reliability, pharmacovigilance, and other areas.

Details from the report were published in an Aug. 16, 2021 press release from the EMA and the full report is available via ICMRA’s website. Implementation of the report is due to be discussed by ICMRA members in the coming months.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

ICMRA Sets Out Recommendations on Regulation of Future Therapies Using AI

The European Medicines Agency (EMA) announced in an Aug. 16, 2021 press release that it has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19 who are already undergoing corticosteroid treatment and require extra oxygen or mechanical ventilation.

According to the press release, RoActemra is being considered as a potential treatment for COVID-19 as a result of the therapy’s ability to block the action of interleukin-6, which is a substance that the immune system produces in response to inflammation. EMA’s Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data that has been provided within the application, which include results from four large, randomized studies.

During its review, CHMP will discern whether or not an extension of indication for RoActemra is suitable and will provide its opinion, along with any recommendations for further studies or additional safety monitoring, to the European Commission. The commission will make the final legally binding decision on the indication extension, which will apply to all European Union member states.

Further information on the progress of the assessment and the outcome will be communicated by EMA. The agency expects to be able to provide an update by mid-October unless additional information is required.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.