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COVID-19 And Its Implications

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

COVID-19 Vaccines: Novavax Gets Reprieve With US FDA Panel Supporting JN.1 Formulation

Advisory committee members said having Novavax’s protein-based vaccine available in the fall was important, but would not have been possible if a different variant strain were used. They also worried separate recommendations by vaccine type would cause confusion.

Amended International Health Regulations Give Fresh Momentum To Pandemic Treaty Talks

The amendments agreed by the World Health Assembly include a definition of a pandemic emergency as well as ways to help improve access to health products.

DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep

The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.

Pandemic Treaty Talks Flounder But WHO Still Holds Out Hope For Eventual Agreement

At this week’s World Health Assembly, a working group will be set up to discuss the next steps for talks on a global pandemic treaty and try to reach a final agreement on amendments to the International Health Regulations.

International Health Regulation Changes Focus On Equitable Access And Production Capacity

The final version of amendments to the IHR is due to be discussed at this week’s World Health Assembly, alongside the way forward for the proposed global pandemic treaty.

Lessons Learned From COVID-19 That Are Key To Future Global Pandemic Response

Panelists at a webinar discussed what went awry in the global response to the COVID-19 pandemic and the lessons to be learned in future in areas such as procurement, equitable access and regulatory processes.

FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say

Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.

Pandemic Treaty Negotiators Plan Five More Days Of Talks On ‘Critical’ Issues

A co-chair of the Intergovernmental Negotiating Body says that whatever happens over the coming fortnight, a report on the outcome of the talks will be delivered to the World Health Assembly at the end of this month.

Pandemic Treaty Talks Go Up To The Wire

The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.

Updated COVID-19 Vaccines Should Target New JN.1 Variant, Says EMA

Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.

US FDA’s Vaccine Office Emerges From Non-COVID-19 Backlog

The Office of Vaccines Research and Review's delayed receipt policy ended in 2023, but took another two months to fully unwind, Director David Kaslow said.

Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Industry & Regulators To Align Advice on COVID-19 Vaccine Updates

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.

Ivermectin Settlement Brings Relief And Worry For US FDA Communications

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

Quick And Flexible Vaccine Approval Must Include Postmarket Simplicity, US FDA’s Kaslow Says

After making the COVID-19 vaccines available, multiple presentations based on age and vaccination status created confusion that likely hindered uptake, said OVRR Director David Kaslow.