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Tuesday, May 19, 2020

WATCH: Vaccine Laban sa #COVID19 Nadiskubre at Nagpakita ng Magandang Resulta

Isang biotech na kumpanya sa Amerika, ang Moderna ang naglabas ng resulta ng Phase 1 clinical trial ng denedevelop nila na vaccine laban sa Corona Virus 2019 o COVID19. Sa ilang katao na natest na ay may 8 na mga participants ang may lumabas na magandang resulta, at may nakitang neutralizing antibodies sa kanilang katawan. Ibig sabihin, gumagawa mismo ang kanilang katawan ng mga mga anti bodies sa tulong ng vaccine na nilalabanan ang corona virus, at nananatiling safe ang mga naturukan ng vaccine na ito. Sa pag-aaral pa ng Moderna, na ginamitan ng daga o mice, pagkatapos naturukan ng vaccine, napag-alaman na hindi tinatamaan ng corona virus ang daga na may vaccine.
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 Ayun pa sa Moderna, sa July mag-uumpisa ang malakihang clinical trial,  at maaring sa January to June 2021 ay magiging available na ang vaccine sa market. Narito ang video ng biotech na Moderna na nageexplain ng kanilang ginawang trial, at kung paano sila nakadevelop ng mRNA-1273 in just 42 days.

Ayun pa sa announcement ng Moderna mismo:

After two doses all participants evaluated to date across the 25 µg and 100 µg dose cohorts seroconverted with binding antibody levels at or above levels seen in convalescent sera

mRNA-1273 elicited neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera

mRNA-1273 was generally safe and well-tolerated

mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model. Anticipated dose for Phase 3 study between 25 µg and 100 µg; expected to start in July
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Narito naman ang interview sa isa sa mga nabigyan ng vaccine at kasali sa clinical trial na ito.

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Ayun pa sa kumpanya, naapprove na ng FDA ng USA ang pagsasagawa nila ng pangalawang trial at ang pangatlong trial ngayong July 2020 at magiging available na ito next year. 

Phase 1 safety and immunogenicity data from the trial being run by the NIH is expected to guide our next steps. Given the pandemic, we have started to work in parallel to responsibly accelerate further development.

The Company is actively preparing for a potential Phase 2 study under its own Investigational New Drug (IND) filing to build on data from the ongoing Phase 1 study being conducted by the NIH. To continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data. Manufacture of the mRNA-1273 material for the potential Phase 2 trial, which could begin in a few months, is underway. Moderna continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.

Our goal is to generate data that will demonstrate the safety and effectiveness of mRNA-1273 against infection caused by SARS-CoV-2.

"Moderna has already started to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit. We are working around-the-clock to make sure a vaccine is available as quickly and as broadly as possible. We will continue to work together, with government, industry and other third parties to enable the best chance for success."

CNN REPORTS


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U.S. researchers administered the first shot to the first person in a test of an experimental coronavirus vaccine. With a careful jab on a healthy volunteer's arm, scientists at the Kaiser Permanente Washington Research Institute began an anxiously-awaited first-stage study of a potential COVID-19 vaccine. Even if the research goes well, a vaccine wouldn't be available for widely use for 12-18 months, according to the U.S. National Institutes of Health. The trial vaccine, code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company Moderna Inc. There are no chance participants can get infected from the shots because they don't contain the coronavirus itself. Kaiser Permanente screened dozens of people, looking for those who have no chronic health problems and aren't currently sick. Participants are paid 100 U.S. dollars for each clinic visit during the study.

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