COVID News: Pfizer, Moderna, GSK & More
By

The latest on COVID-19 vaccines/drugs and testing from Moderna, Pfizer, BioNTech, Novavax, GSK, SK bioscience, and Celltrion. Highlights below.

COVID-19 treatments and vaccines
* Moderna Seeks EU OK of COVID Vaccine in Children Under Six
* FDA Sets Meetings for Review of COVID-19 Vaccines 
* Pfizer Reports Additional Results of Oral COVID Drug
* Novavax Seeks UK OK of COVID-19 Vaccine in Adolescents
* GSK, SK bioscience Seek OK for COVID-19 Vaccine in South Korea
COVID-19 testing
* Celltrion Recalls COVID-19 Rapid Test Kits


Updates on COVID-19 treatments and vaccines

Moderna Files for EU OK of COVID Vaccine in Children Under Six
Moderna has submitted to the European Medicines Agency a request for a variation to its conditional marketing authorization for a 25-µg two-dose series of Spikevax, the company’s COVID-19 vaccine, in children six months to under six years of age. Similar requests are underway with international regulatory authorities.

In February (February 2022), the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Spikevax to include children six years of age and older. Moderna is currently studying booster doses for all pediatric cohorts.

Source: Moderna


FDA Sets Meetings for Review of COVID-19 Vaccines 
The US Food and Drug Administration (FDA) has scheduled virtual meetings in June of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review requests by Pfizer/BioNTech, Moderna, and Novavax regarding their emergency use authorization (EUA) for their respective COVID-19 vaccines as well as to discuss whether SARS-CoV-2 strain composition of COVID-19 vaccines should be modified for this coming fall (fall 2022).

On June 7, 2022, the FDA intends to convene VRBPAC to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.

On June 8, 2022, June 21, 2022, and June 22, 2022, the VRBPAC will meet to discuss updates to Moderna’s EUA and Pfizer/BioNTech’s EUA for their respective COVID-19 vaccines to include younger populations. As the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request.

On June 28, the FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for the fall of 2022. This meeting is a follow-up to an April 6, 2022, VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to further meet public health needs.

Source: US Food and Drug Administration and Novavax


Pfizer Reports Additional Results of Oral COVID Drug
Pfizer reported Phase II/III results for Paxlovid (nirmatrelvir tablets and ritonavir tablets), its oral COVID-19 drug, which showed that a primary endpoint was not met for reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact.

Paxlovid is authorized for emergency use by the US Food and Drug Administration (FDA) for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with tested positive for the virus, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The drug is currently approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients.

Source: Pfizer


Novavax Seeks UK OK of COVID-19 Vaccine in Adolescents
Novavax, a Gaithersburg, Maryland-based vaccine company, has submitted a request to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to expand the authorization of its COVID-19 vaccine, Nuvaxovid, to adolescents aged 12 through 17.

The MHRA had earlier granted conditional marketing authorization for Nuvaxovid in individuals 18 years of age and older in February 2022.

In the 12 through 17 year-old population, Novavax continues to submit regulatory filings globally, with emergency use authorization in this age range granted in India.

Source: Novavax


GSK, SK bioscience Seek OK for COVID-19 Vaccine in South Korea
GlaxoSmithKline (GSK) and SK bioscience, a vaccine developer and manufacturer based in South Korea, have submitted a biologics license application (BLA) for SKYCovione, a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety.  

The approval of SKYCovione is through a formal BLA procedure, not a conditional approval process. In March (March 2022), SK bioscience signed an advance purchase agreement with the Korea Centers for Disease Control and Prevention for 10 million doses of the vaccine.

In addition, SK bioscience says it will apply for emergency use listing (EUL) to the World Health Organization (WHO) and authorizations at individual regulatory agencies globally.

A Phase III trial in adolescents between 12 to 17 years-old is expected to begin in the first half of 2022. In addition, an extended clinical trial seeking to test the preventive effect of the vaccine against COVID-19 variants such as Omicron is planned.

Source: GlaxoSmithKline and SK bioscience


News on COVID-19 testing

Celltrion Recalls COVID-19 Rapid Test Kits
Celltrion USA, the US arm of Celltrion, an Incheon, South Korea-based biopharmaceutical company, is recalling 311,100 units of its COVID-19 rapid test, which may have been distributed to unauthorized users. The tests were distributed in the US between December 2021 to February 2022

The point of care (POC) Celltrion DiaTrust COVID-19 Ag Rapid Test is used to detect the presence of SARS-CoV-2, based on a nasopharyngeal swab sample from patients collected by healthcare providers. The affected tests may have been distributed to unauthorized users. This test is authorized for use only by laboratories with CLIA certification and a corresponding CLIA certificate number.

Although there have been no reports of injuries to date, adverse health consequences, or death associated with the use of these affected products, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus, notes the US Food and Drug Administration (FDA) in a recall notice. The FDA has identified the recall as a Class I recall, which is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Source: US Food and Drug Administration