Out of the nine US companies that are in their final stages of clinical trials for vaccine development against Copvid-19, Moderna becomes the first biotech firm to publish the blueprints of its study on Thursday, September 17, 2020.

Following this, Pfizer, another US-based biotech firm is currently in the later stages of its phase-3 clinical trials. Additional pressure is now faced by the company after Moderna has already released its study layout. The CEO of Pfizer has repeatedly claimed that the company will have its final results by October, as expected by the president.

In the run-up to the upcoming US-elections in November, the US government led by Donald Trump has been pressurizing the organizations involved in the Covid-19 vaccine development, to lay off the criticism faced by them for poor management of the pandemic.

On Wednesday, September 16, 2020, the US president made a statement claiming that the vaccine will gain approval by the month of October. This raises concerns that the White House will be pressurizing the Food and Drug Administration (FDA) for approval of their vaccine which might be troublesome regarding the effectiveness and safety of the drug.

The healthcare experts and the officials in the Republican President’s Administration say that it is nearly impossible to predict the results of ongoing trials and it is unlikely to expect a vaccine approved by the end of this year, leave alone by the end of October.

Joe Biden, presidential nominee from the Democratic Party made a statement on Wednesday, September 16 that Donald Trump cannot be trusted in matters related to his response to his claims of having an approved vaccine ready by October.

The CEO of Moderna said that they will be finalizing the effectiveness of the vaccine by November and that expecting this to be done by October is far-fetched.

The immunization trials are not that easy. Moderna officials claim that the results are studied by comparing a group of people who are naturally infected by the virus, with another group that has been administered with the vaccine. The dropping rate of infection in the USA will further delay this process, maybe till December.

A total of 25,296 volunteers have been registered by Moderna on Thursday, September 17, for its phase-3 clinical trials, out of which 10,025 have been administered with second dose of the drug after 28 days of the first dose. Around 28% of the participants are from various racial minority groups, to obtain statistically representative results for various communities hit disproportionally by the pandemic.

The Covid-19 infections that occur only after 2 weeks of the second dose of test vaccine administration are recorded, to give the vaccine sufficient time to start acting.

The trial protocol of Moderna has the key information for stopping rules, interim analyses, and efficacy assumptions as stated by the director of the Scripps Research Institute, Eric Topol. He further added applause for the transparency of Moderna.

The final stage of vaccine development is the phase-3 clinical trials, in which the drug is administered and studied on human participants to test its side-effects, safety, and effectiveness.

A committee of independent experts has been finalized for short-term analysis of the trials to verify the high statistical threshold of vaccine effectiveness and to record any serious side-effects. As per the FDA, the minimum value of percentage for a vaccine to gain approval is to reduce the infection chances by 50%.