Moderna Raises Vaccine Manufacturing Goals and Other COVID-19 News

Moderna_ Craig F. Walker/Boston Globe via Getty

 Craig F. Walker/The Boston Globe via Getty Images

With COVID-19 still running rampant across the globe, Moderna announced it will rapidly expand its vaccine manufacturing operations in order to meet demand in the countries where the medication has received emergency authorization.

The company said it will increase its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021. Moderna previously partnered with Lonza to manufacture its mRNA vaccine.

Cambridge, Mass.-based Moderna said it expects about 100 million doses to be available in the United States by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. To date, about 18 million doses have already been supplied to the U.S. government, Moderna said Monday. The U.S. government has committed to purchase 200 million doses of Moderna’s COVID-19 vaccine.

Other countries are also lining up for Moderna’s vaccine. Days after the U.S. government greenlit Moderna’s vaccine, the Canadian government also authorized the medication and has agreed to purchase 40 million doses. This morning, the government of Israel announced the authorization of the Moderna vaccine in that country and has already secured 6 million doses. According to the Johns Hopkins COVID-19 dashboard, Israel has 451,044 confirmed cases of COVID-19, with 3,448 related deaths.

Additional authorizations are currently under review in the European Union, Singapore, Switzerland and the United Kingdom. Moderna Chief Executive Officer Stéphane Bancel said he hopes to continue to see authorizations in additional markets in the coming days, weeks and months.

“Our effectiveness in providing early supply to the U.S. and Canadian governments and our ability to increase baseline production estimates for 2021 are both signals that our scale up of mRNA vaccine production is a success,” Juan Andres, Chief Technical Operations and Quality Officer at Moderna said in a statement.

Elsewhere in the fight against COVID-19:

FDA Warning -- While Moderna ramps up its manufacturing, the U.S. Food and Drug Administration issued an alert Monday warning of the potential of false-negative results from a test developed by California-based Curative due to the manner in which some specimens have been obtained. The Curative PCR-based test was authorized for use in April for use with throat swab, nasopharyngeal swab, nasal swab or oral fluid specimens. However, Modern Healthcare noted that accurate results from the test rely on following the proper guidelines. The use of nasal swabs and oral fluid specimens are only to be used on patients within two weeks of the onset of COVID-related symptoms. Proper specimen collection must also be observed, MH reported.

"When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate," the FDA announced in its safety communication, Modern Healthcare reported.

Quarantine – In December, the U.S. Centers for Disease Control and Prevention changed its quarantine guidelines to seven days and a recent study suggests that should be sufficient for some households. A study conducted by the University of Minnesota’s Center for Infectious Disease Research Policy found that only “19% of people exposed to a COVID-19 patient in their home who had no symptoms nor a positive test result in the first 7 days of the patient's illness later tested positive.” That suggests the 7-day quarantine could be effective in many cases, the report said.

The latest study was conducted by 185 household members of 105 COVID-19 patients at Vanderbilt University Medical Center and Marshfield Clinic Research Institute. The patients agreed to maintain a symptom diary and provided respiratory specimens for 14 days. The study showed that of those 185 contacts, 109 (59%) tested positive during the study period. Also, the study showed that 83 of the test results (76%) yielded positive results within one week, and 94 (86%) being positive within 10 days after the index patient became ill.

“Contacts with negative COVID-19 test results and no symptoms in the first 7 days had an 81% chance of continuing to have no symptoms or test positive through day 14. Those odds increased to 93% for those without symptoms or positive test results in the first 10 days,” the report said.

The researchers concluded that a 14-day quarantine is still the best strategy to reduce community spread of COVID-19. However, if a patient has access to a sensitive COVID-19 test after seven days, it could reduce the time for those who remain asymptomatic and continue to test negative.

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