Moderna’s COVID-19 vaccine stimulated an immune response in all 45 trial subjects

The vaccine was developed by Moderna and the National Institute of Allergy and Infectious Diseases in Phase I trials. Moderna will report some results in mid-May, the vaccine is in the mid- stage, with the final stage expected to start on July 27 with 30,000 adults.

“No matter how you slice this, it’s good news,” Dr. Anthony Fauci, a leading infectious disease expert in the US government, told The Associated Press.

Moderna, whose inventory has grown by more than 200% this year, has been criticized for failing to share backup data as the company overwhelmed the media and sparked expectations. It was published by the journal on Tuesday.

Neutralizing antibodies were detected in all evaluated participants at levels well beyond that in 38 patients with a confirmed diagnosis of COVID-19 after the second shot of volunteers. It was

However, the authors of the study said that how long the immune response lasted was not an important issue when weighing vaccine efficacy. Participants will be monitored for one year after receiving the second shot to see if they are immune.

Dr. Penny Heaton, chief executive officer of the Bill & Melinda Gates Institute of Medicine in Cambridge, wrote in the NEJM editorial that the data are promising, but cautioned.

“Many Phase 3 trials failed because of the misidentification of doses that best balance safety and efficacy,” she wrote.

Unlike traditional vaccines that use weakened or killed viruses to stimulate the immune response, Moderna’s vaccine relies on genetic material called messenger RNA (mRNA). Vaccines insert a portion of coronavirus RNA into cells and produce a portion of the cells to produce antibodies.

Not uncommon in the biotechnology world, the unmarketed company set the record for the pharmaceutical industry by producing a vaccine 42 days after receiving the viral gene sequence. However, Moderna is one of a few people trying to prevent coronaviruses, but no messenger RNA vaccine has been approved to prevent any disease.

Other mRNA vaccines being tested include those developed by Pfizer, a leading pharmaceutical company, and BioNTech, a German biotechnology company.

More than half of the 45 participants who received the Moderna vaccine reported side effects such as injection site fatigue, chills, headaches, body aches and pain. This was more common, especially at the highest dose, after the second vaccination, but none of the side effects were considered serious.

Forty-five volunteers from the initial trials in Seattle received doses of 25 micrograms, 100 micrograms, and 250 micrograms.

Moderna’s Chief Medical Officer Dr. Tarxax said in Phase 1 data that vaccination with mRNA-1273 elicits a strong immune response at all dose levels and clearly supports 100 microgram selection. I will prove it.” Optimal dose for Phase 3 trial.

“We look forward to launching a Phase 3 trial of mRNA-1273 this month to show that the vaccine can significantly reduce the risk of COVID-19 disease,” he said.

The project received $843 million from the Federal Office for Advanced Biomedical Research and Development. It is one of at least four potential COVID-19 vaccines, backed by the Operational Warp Speed, a federal initiative to accelerate antivirus development.

On Tuesday, Moderna posted details of its final stage vaccine trial on the government’s website, confirming that the widely anticipated trial will begin this month. Moderna said the trial is expected to begin on July 27 and will enroll 30,000 adults at high risk of contracting the coronavirus.

A spokeswoman for Moderna said the trial site will begin registering next week.

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Jonathan Salzman [email protected]