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The biotechnology company Moderna has just published the first results of the first phase of clinical trials on the SARS-CoV-2 coronavirus vaccine. A few days earlier, the company announced that the US Food and Drug Administration (FDA) agreed to enter the second round of a clinical trial involving 600 people.
Moderna was one of the first to develop a vaccine
The biotechnology company Moderna was one of the first to develop an experimental vaccine against the SARS-CoV-2 coronavirus. A vaccine called mRN-1237 was shipped to the National Institute of Allergy and Infectious Diseases (NIAID) in the United States six weeks after work began.
On March 16, the first participant in Phase I clinical trials on the vaccine received an experimental dose. The study, which took place at the Kaister Permanente Washington Health Research Institute in Seattle, was attended by, inter alia, Jennifer Haller, who told how the tests look in practice.
Positive results of the first test phase
45 volunteers aged 18 to 55 participated in the first phase of the clinical trials. They were randomly divided into three groups. Each participant of the study was vaccinated twice with the vaccine of different doses: 25 µg, 100 µg and 250 µg. Studies published by Moderna show that all study participants developed binding antibodies.
The 15 subjects who received the lowest dose had levels of antibodies in their blood similar to those who received the higher doses of the vaccine. The 10 people who received the higher dose of the vaccine (two doses of 100 µg) developed antibodies that exceeded those seen in convalescent sera from people who underwent COVID-19 and developed antibodies.
they are produced in people who have been infected but are incapable of preventing viral infection. They act as a diagnostic indicator – they show whether a person has been infected or not. They “mark” a place in the body, “show” the immune system where the virus is.
Data from Moderna showed that the vaccine was “generally safe and well tolerated”. Serious, but not life-threatening, side effects were seen in the three study participants who took the highest doses of the vaccine. In the 25 and 100 µg dose groups, one participant developed third degree erythema after injection.
As we read on the company’s website, data on neutralizing antibodies are now available for the first four participants from each of the 25 µg and 100 µg dose groups. Consistent with the binding antibody data, vaccination with mRNA-1273 elicited neutralizing antibodies in all eight of these participants.
neutralize the pathogen and make it lose its infectious capacity.
‘These provisional Phase 1 data, albeit at an early stage, show that vaccination with mRNA-1273 elicits an immune response comparable to that produced by natural infection, starting with a dose as low as 25 µg,’ said Dr Tal Zaks, lead researcher at Modernie.
Pre-clinical studies in mice are also available, which have been carried out in collaboration with NIAID and academic partners. A study in mice showed that vaccination with mRNA-1273 prevented the virus from replicating in the lungs of rodents that had been exposed to SARS-CoV-2.
See also: Race for the COVID-19 vaccine
Phase II clinical trials as soon as possible
The Phase II clinical trial, for which Moderna has received approval from the FDA, will involve 600 healthy volunteers aged 18 to 55 and over 55 years of age. Participants will be randomly assigned to particular groups. One will receive a placebo, the second will receive two doses of 50 µg of the vaccination, and the third will receive two doses of 250 µg. Participants will be followed for 12 months after receiving the second dose of the vaccine.
The main purpose of this part of the study is to determine whether the vaccine is safe and whether the positive results obtained in the first phase of the study can be replicated in a much larger group. If the second phase of the research is successful, the second phase will start, which will accurately determine the effectiveness of the vaccine.
Phase I: This is the first clinical experience in which a new experimental vaccine is administered to humans. Phase 1 can last up to 24 months and typically involves 20 to 100 volunteers. This phase collects data on the safety of the vaccine, with particular attention to possible side effects. It can also provide knowledge about the dose and schedule of vaccine administration. Volunteers participating in this phase of clinical trials may differ in age from the target group. If the observations made in this phase show that the new vaccine is safe, well-tolerated and promising, phase II clinical trials can begin.
Phase II: May last more than two years and typically involves 100-300 volunteers. Information on the experimental vaccine safety and immunogenicity is gathered at this stage. Phase II can be sped up by the Intermediate Phase (IIb) studies which allow a preliminary assessment of the efficacy of the new vaccine by comparing the incidence among vaccinated and unvaccinated control volunteers.
Phase III: The most promising vaccines are qualified to this phase. The study is designed with 10 or more volunteers and may last up to 000 years. Through these studies, enough data can be gathered on the safety and efficacy of the vaccine for approval by registration and regulatory authorities. In the United States, for ethical reasons, the principle of testing the effectiveness of vaccines in animal models has been introduced by law. (source: badaniaklinicznewpolsce.pl)
What do we know about the COVID-19 vaccine developed by Moderna?
The vaccine prepared by Moderna is an mRNA vaccine. It does not contain the SARS-CoV-2 coronavirus, neither in a ‘live’ (virulent) or attenuated version. Its production was entirely based on genetic engineering.
The attenuated vaccine contains a live pathogen which is rendered ‘virulent’ by attenuation. Attenuated microorganisms retain antigenic properties, and vaccines containing them show good protective properties.
The mRNA-1273 vaccine contains an artificially created RNA fragmentwhich contains instructions on how to build a receptor on the surface of the virus. In theory, this fragment is supposed to penetrate cells and “teach” them to produce a receptor protein identical to that found on the surface of the coronavirus. Then, the protein created in this way activates the immune system and “forces” it to produce antibodies against this particle. Without getting sick, without using real virus particles, immunity to the key protein present in the virus particle should be developed. In theory, the “learned” immune system should react when the vaccinated person actually comes into contact with the coronavirus.
Aleksandra Mościcka-Studzińska, coordinator of pharmacy and biotechnology at the National Center for Research and Development, said in an interview with Medonet, “work on the vaccine is going on as fast as COVID-19 spreads”.
According to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, we will have to wait at least 19 years for the COVID-1,5 vaccine. Moderna, in turn, announces that the third phase of clinical trials could start as early as July 2020 and hopes that the final vaccine will be approved as early as 2021.
More information about vaccines:
- Pfizer: First Patients Received Potential Coronavirus Vaccine
- Are we going to get vaccinated against COVID-19 the way we get the flu vaccine now?
- COVID-19 vaccine produced in tobacco leaves? An innovative solution
- Does giving plasma from a healed person help in treating COVID-19?