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Sarah Karlin-Smith

Sarah is a senior writer at the Pink Sheet, specializing in the policy and politics that affect the pharmaceutical industry. She covers the US Food and Drug Administration, Centers for Medicare and Medicaid Service and Congress. Her work explores how government policies influence how drugs are developed and approved, what diseases are prioritized by scientists, and who gets access to medicines and at what cost. Sarah has covered health care since 2011. Prior to returning to the Pink Sheet in March 2020, she covered health policy at Politico for five years.

Latest From Sarah Karlin-Smith

US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement

After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign. 

Coronavirus COVID-19 Vaccines

Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Advisors Intrigued by Novavax As Booster

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

Coronavirus COVID-19 Vaccines

US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.

Advisory Committees Vaccines

COVID-19 Vaccine Refresh For Boosters Only? US FDA Position On Primary Series May Have Shifted

FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time. 

Advisory Committees Coronavirus COVID-19

Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

United States FDA

US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’

Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.

Coronavirus COVID-19 Vaccines
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