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J&J does not think single-dose vaccine against covid will be approved in February

(Bloomberg) – Johnson & Johnson’s long-awaited single-dose covid vaccine will not be authorized until March, weeks after U.S. officials suggested. According to experts from the Operation Warp Speed ​​program, the vaccine could receive the approval for emergency use by US regulators in the middle of next month. However, this timeframe could be aggressive depending on the pharmacist’s expectations of when they will have reliable data demonstrating the efficacy of the single-dose vaccine. J&J will be able to analyze data from late-stage trials only during the last week of January or the first week of February, Chief Scientist Paul Stoffels said in an interview Tuesday. From then on, the company will need a week or two to analyze the data and prepare the documents for regulators in the United States and other countries, he added. “We hope and trust that sometime in March we can get that approval.” Stoffels said. This disconnect represents another potential blow to a US immunization campaign that has not lived up to expectations. Inconsistent messages and a patchwork of rules have led to long lines and congested vaccination sites in some states, while others have struggled to distribute the vaccines they have received. At the current rate of vaccination, the US will not reach 75% of immunity, the estimated level at which viral transmission will practically stop, until 2024, according to London-based consultancy Airfinity Ltd. If President-elect Joe Biden’s Administration succeeds in increasing vaccination rates enough to meet projected production levels, herd immunity could be achieved in August, Airfinity estimated. J & J’s vaccine may still get. authorization for emergency use at the end of February, if each of the parts of the process – from the submission of an application to the convocation of the advisers of the Food and Drug Administration to evaluate the data of the trials – proceed to fast-paced, according to the company.Operation Warp Speed, the U.S. effort to accelerate vaccine development and distribution, relies on a faster schedule. Vaccine Program Chief Advisor Moncef Slaoui said Tuesday that J&J’s vaccine could receive clearance in mid-February. Original Note: J&J Sees Decision on Vaccine Clearance Coming by MarchFor more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source. © 2021 Bloomberg LP

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