Coronavirus Vaccine

 Experimental coronavirus vaccine highly effective

At a glance

Clinical trial results show that the investigative vaccine known as mRNA 1273 is 94.1% effective in preventing symptomatic CoVID-19.

These results indicate that the vaccine, now approved by the FDA for emergency use, is safe and effective.

Researchers are working to develop a safe and effective vaccine against SARS-CoV-2, the corona virus that causes COVID-19. A vaccine candidate, called mRNA-1273, developed by researchers at NIH's National Institute of Allergy and Infectious Diseases (NIAID) and the biotech company  showed preliminary results showing serious side effects. Can trigger an immune response against the virus. .

To further investigate the safety and efficacy of this vaccine, a research team led by Dr. Lindsay R.  of Boston's Brahms and Women's Hospital, Dr. Hannah ML Sahil of the Boiler College of Medicine, and Dr. Brandon Eisenhower. Meridian Clinical Research conducted clinical trials with more than 30,000 adult volunteers across the country. Participants were 18 years of age or older who did not have a previous SARS-Co-2 infection. The results were published in the New England Journal of Medicine on 30 December 2020.

Volunteers were randomly assigned to receive two doses of the investigative vaccine (100 micrograms each) or two shots of salted placebo. He received his first injection between July 27 and October 23, 2020. The second shot was fired 28 days later.

Investigators recorded 196 episodes of the symbolic COVID-19 between participants at least 14 days after their second shot. Only 11 of these cases were in the group that received the vaccine, and none of them are suspected. In contrast, there were 185 incidents in the placebo group, of which 30 were severe. Thus, the incidence of symptomatic CoVID-19 was 94.1% lower in participants who received mRNA-1273 than in placebo recipients. For participants 65 years of age or older, the utility was 86.4%.

There was no talk of immunizations. Local reactions to the vaccine were usually mild. After the second dose, approximately half of the NA participants experienced moderate to severe side effects such as fatigue, muscle aches, joint pain, and headaches. In most volunteers, this is resolved in two days.

One potential concern about the COVID-19 vaccine is an unusual phenomenon called vaccine-related respiratory disease or VAERD. VRD can occur when a vaccine triggers an immune response that causes the disease to become more serious if you are exposed to the virus. However, the team found no evidence of VAERD among the recipients of MRNA-1273.

"We still don't know about the Stork Cove 2 and Cove 19," he said. However, we do know that this vaccine is safe and that it can prevent symptomatic COVID-19 and serious illness, "said Dr. Anthony S.  director of NIAID. If available, they will protect themselves by vaccinating all Americans against polio. In the same way, our country will be healed and move forward.

The FDA issued an emergency use permit (link is external) on December 18, 2020 for the availability of a vaccine to prevent COVID-19 in adults.

Although mRNA-1273 can inhibit symptomatic CoVID-19, further studies are needed to determine whether it protects against SARS-CoV-2 transmission. Additional analyzes are also underway to understand the effects of the vaccine on asymptomatic infections.

                                                                                                                                       

Experimental coronavirus vaccine is safe and produces immune response

Researchers are working to develop a safe and effective vaccine against SARS-CoV-2, a novel coronavirus that causes COVID-19. Before a vaccine is available to the public, it must go through several stages of testing. The first phase is the Phase 1 clinical trial. In Phase 1, the vaccine is given to healthy volunteers to test if it is safe and develops an immune response to the virus.

Scientists began testing the first phase of an experimental vaccine for Covid 19 in mid-March. The vaccine, called MRNA-1273, is being developed jointly by researchers at NIH's National Institute of Allergy and Infectious Diseases (NIAID) and the biotech company Moderna, Inc.

The two-dose vaccine is designed to develop antibodies against a portion of the corona virus "spike" protein, which the virus uses to bind and infect human cells. The vaccine uses Messenger RNA (mRNA), a molecule that produces proteins for the virus.

The researchers, led by Dr. Lisa A. Jackson of Kaiser Permanente Washington Health Research Institute, Seattle, published an interim report of the trial results in the New England Journal of Medicine on July 14, 2020.

The team tested the vaccine on 45 healthy adults between the ages of 18 and 55. Participants were enrolled at study locations in Seattle and Atlanta. The volunteers were divided into three groups. Each group received different doses of vaccine (25, 100, or 250 micrograms). Participants received two injections, 28 days apart.

After the second injection, the team assessed the extent to which the vaccine provoked an immune response against SARS-CoV-2. They also tested whether antibodies could neutralize the virus in the laboratory. Safety was also assessed throughout the trial.

The research vaccine developed a strong immune response and was generally well tolerated. Antibody levels were higher with higher doses of the vaccine. In both the medium and high dose groups, the researchers observed high levels of neutralization of antibody activity during day 43 after the second injection. This level was similar to the upper range found in patients who have recovered from COVID-19.

None of the participants experienced any serious side effects from the vaccine. However, more than half reported fatigue, headaches, chills, or pain at the injection site. These symptoms were the most common after the second vaccination and received the highest dose of vaccine. Based on side effects and immune response, 100 micrograms of dose was selected for the next stage 3 trial.

The Phase 1 trial is ongoing and currently has 120 participants. In April, researchers enrolled adults 55 years of age and older. A major Phase 2 clinical trial of mRNA-1273, organized by Moderina, began enrollment in late May. During this phase, researchers will continue to monitor vaccine dosage and immune response. Plans are underway to launch a Phase 3 trial later this month to test the effectiveness of the vaccine in thousands of people.

"The search for a safe and effective vaccine to prevent SARS-CoV-2 infection is an immediate public health priority," said Dr. Anthony S. Fookie, director of the NIAID. "The initial results of this trial are an important milestone in this endeavor."