EC to relax GMO rules to aid SARS-CoV-2 vaccine trials

The European Commission wants to relax rules on environmental risk assessments for genetically modified organisms (GMO) to help vaccine developers during the coronavirus pandemic.

The Commission proposed the relaxation last week, explaining the move would apply to vaccines under development for SARS-CoV-2.

It said, “The development of vaccines and therapies against the virus [SARS-CoV-2] is of major public interest and we are collectively called to make safe and efficacious medicinal products available to our citizens as soon as possible. Some of the vaccines under development are based on genetically modified viruses and may fall within the definition of GMO.

“It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines.”

At present directives, 2001/18/EC and 2009/41/EC, cover the safe handling of GMOs in the EU member states – including their use in clinical trials. But implementation differs in each country, which could slow the vaccine development process according to the Commission.

Under the proposed relaxation the EC said “the environmental risk assessment and consent under Articles 6 to 11 of Directive 2001/18/EC and Articles 6 EN 8 EN to 13 of Directive 2009/41/EC should not be a prerequisite for the conduct of those clinical trials.”

US FDA commits to flexibility for gene therapy reviews

The US FDA says it is taking a flexible approach to reviews of gene therapies for rare diseases according to a RAPS report.

Elizabeth Hart, branch chief at the Office of Tissues and Advanced Therapies within the Center of Biologics Evaluation and Research, told delegates that although review standards for gene therapies are the same as regular drugs, the agency is flexible.

“We do have the option to exert regulatory flexibility, and this is especially important for rare diseases. Clinical development programs for the different diseases may vary substantially, and so they really need to be individualized,” she said.

Hart cited the number of patients needed for a clinical trial as an area in which the agency give gene therapy firms leeway.

She said, “the number of subjects needed is determined on a case by case basis taking into consideration the persuasiveness of the data, including comprehensiveness and quality; the nature of the benefit provided; the length of the treatment exposure, the patient population that would be treated after marketing approval; and concerns for potential harm from the treatment.”

Read the full RAPS report.

Corning awarded $240m to up US vial capacity to support Covid-19 fight

The US Departments of Defense, Health & Human Services have chosen vials developed by Corning to accelerate delivery of SARS-CoV-2 vaccines.

The US Government has given Corning $240m to expand US manufacturing capacity for its Valor glass vial technology as part of the White House’s “Operation Warp Speed” programme.

CEO Wendell Weeks said, “Our Valor Glass provides the strongest, fastest to fill, and highest-quality pharmaceutical glass vials ever produced. It helps protect patients and addresses existing bottlenecks.

“Corning is ready to do our part in the fight against the pandemic, as well as to help prepare for future public health emergencies.”

Also in the news

CDMOs are playing a major part in the fight against Covid-19 according to a report by Global Pharma Insights.

How the pandemic will impact sector in the long-term is unclear according to DCAT. Author Jim Miller, a CDMO sector consultant, predicts contractors will experience headwinds in the medium term with drug firms delaying product launches and biotechs facing financial pressure.

STAT says the coronavirus pandemic has rekindled the debate about compounding in the US. Many of the drugs needed to treat SARS-CoV-2 infected patients are made by compounders.

Ex-FDA officials say actions by the White House are impacting the agency’s ability to provide scientific and technical guidance.

Former agency head Scott Gottlieb questioned whether certain policies will advance patient care, and ex FDA Principal Deputy Commissioner Joshua Sharfstein called for the White House Office of Management and Budget to be more transparent in its reviews. Read the full Inside Health Policy report.

CDMO tends

Some developments of note in the contracting space:

PharmAbcine has hired Thermo Fisher Scientific for the development and manufacturing of PMC-309, an immune checkpoint blockade candidate cancer therapy.

Spicona has asked Catalent to develop its SARS-CoV-2 vaccine candidate. Under the deal the CDMO will use its GPEx tech to develop a cell line that expresses the proteins that make up the vaccine.

Sharp has launched a direct to patient service for pharmaceutical companies trialling drugs in Europe.

Oxford Biomedica has signed a collaboration deal with the Vaccines Manufacturing and Innovation Centre (VMIC) to enable the manufacture of viral vector based vaccines.

AstrZeneca has hired Emergent Biosciences to make its candidate SARS-CoV-2 vaccine in the US. See press release.