A study shows efficacy in the world of Moderna and Pfizer / BioNtech vaccines

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Researchers in the United States have conducted a study demonstrating the real-world effectiveness of the recently approved Moderna and Pfizer / BioNtech vaccines in protecting against infection with severe acute respiratory coronavirus syndrome 2 (SARS-CoV-2) – the causative agent of coronavirus infection 2019 (COVID-19).

The team – from Nference in Cambridge, Massachusetts and the Mayo Clinic in Rochester, Minnesota – found the results to be consistent with the results reported in large-scale randomized clinical trials of 3.

The results showed that the vaccines are effective in preventing infection and reducing the severity of COVID-19.

Venky Soundararajan and colleagues also show that vaccination effectively protects people at greatest risk of becoming infected with SARS-CoV-2 and getting severe infection.

“Building on previous randomized trials of these vaccines, this study demonstrates their worldwide effectiveness in reducing SARS-CoV-2 infection rates and severity. COVID-19 is among those most at risk for infection, ”the researchers wrote.

A pre-printed version of the research paper can be found on the medRxiv* server, while the article is subject to peer review.

Study: FDA-authorized COVID-19 vaccines are effective according to worldwide evidence compounded across a multi-state health system. Image credit: NIAID

Both vaccines are distributed in the United States

In 2020, large-scale phase 3 clinical trials showed that the Pfizer / BioNTech BNT162b2 vaccine is 95% effective in inhibiting COVID-19 immunization and that the Moderna mRNA1273 vaccine is 94.1% effective.

Both of these vaccines are now being rolled out across the United States, with priority given to those at high risk of infection or serious infection.

However, “although these groups were not excluded from the phase 3 trials, vaccine efficacy was not particularly demonstrated among them,” said Soundararajan and colleagues.

“It is therefore essential to examine the results of patients who have been vaccinated to date to determine whether these vaccines are indeed effective in high-risk people. ”

Schematic reveals the algorithms for participant selection and outcome evaluation. (A) Study design to compare SARS-CoV-2 infection rates in patients receiving COVID-19 vaccine compared with 1-to-1 bias matching unvaccinated patients (n = 31,069 per group ). For each group, frequency levels were measured to assess vaccine efficacy in preventing SARS-CoV-2 infection, as described by advanced PCR testing, with onset at least 36 days after the first dose or the date of registration of the inspection. Several other time windows have also been evaluated for vaccine efficacy. (B) Study design to compare the depth of COVID-19 infection in patients who received the vaccine prior to COVID-19 diagnosis and who had at least 14 days of follow-up after diagnosis (n = 191 ) against a 1-to-10 bias that matched unvaccinated patients with at least 14 days of follow-up (n = 2,348). Acute outcomes (hospitalization, ICU admission, and mortality) were assessed within 14 days of PCR testing.

Schematic reveals the algorithms for participant selection and outcome evaluation. (A) Study design to compare SARS-CoV-2 infection rates in patients receiving COVID-19 vaccine compared with matching 1-to-1 non-vaccinated patients (n = 31,069 each group). For each group, frequency levels were measured to assess vaccine efficacy in preventing SARS-CoV-2 infection, as described by advanced PCR testing, with onset at least 36 days after the first dose or the date of registration of the inspection. Several other time windows have also been evaluated for vaccine efficacy. (B) Study design to compare the depth of COVID-19 infection in patients who received the vaccine before being diagnosed with COVID-19 and who had at least 14 days of follow-up after diagnosis (n = 191) against a 1-to-10 bias matched unvaccinated patients with at least 14 days of follow-up (n = 2,348). Acute outcomes (hospitalization, ICU admission, and mortality) were assessed within 14 days of PCR testing.

What did the current study cover?

Now, the team has projected worldwide vaccine outcomes in 62,138 people within the Mayo Clinic health system (including Arizona, Florida, Minnesota, Wisconsin) between 1st December 2020 and 8th February 2021.

The researchers assessed the suitability of SARS-CoV-2 and the depth of COVID-19 among 31,069 people who received at least one dose of either the Pfizer / BioNTech BNT162b2 vaccine or the Moderna mRNA-1273 vaccine.

“One challenge that is part of analyzes such as the world is the lack of a built-in placebo arm, which is necessary to establish the expected level of disease during the study period and therefore to evaluate the effectiveness of vaccines, ”wrote Soundararajan and colleagues.

To address this shortage, the researchers used a 1-to-1 bias score match to a group of 31,069 people who had not been vaccinated before the end of the study period.

The time was spread from the first dose of vaccine to the first advanced PCR test, for the patients with at least one advanced PCR test after receiving the vaccine. Patient numbers for mRNA-1273 (Moderna vaccine) are shown in black, and patient counts for BNT162b2 (Pfizer / BioNTech vaccine) are shown in purple. For mRNA-1273, the average time for an advanced PCR test after the first dose is 10.9 days (standard deviation: 6.9 days), and for BNT162b2, the average time for an advanced PCR test is 12.1 days (normal range: 9.1 days). Dotted lines indicate the recommended duration for the second vaccine dose for mRNA-1273 (28 days) and BNT162b2 (21 days).

The time was spread from the first dose of vaccine to the first advanced PCR test, for the patients with at least one advanced PCR test after receiving the vaccine. Patient numbers for mRNA-1273 (Moderna vaccine) are shown in black, and patient counts for BNT162b2 (Pfizer / BioNTech vaccine) are shown in purple. For mRNA-1273, the average time for an advanced PCR test after the first dose is 10.9 days (standard deviation: 6.9 days), and for BNT162b2, the average time for an advanced PCR test is 12.1 days (normal range: 9.1 days). Dotted lines indicate the recommended duration for the second vaccine dose for mRNA-1273 (28 days) and BNT162b2 (21 days).

Vaccination efficacy reached 88.7%

Beginning 36 days after study registration, the prevalence of SARS-CoV-2 was favorable among individuals who received two vaccines at 0.048 cases per 1000 person days, compared with 0.43 cases per 1,000 days among non-vaccinated individuals. .

This is in line with a vaccine efficacy of 88.7%, which the team says is in line with previously reported efficiencies.

Even in the first seven days after enrollment, the prevalence of SARS-CoV-2 was significantly lower among vaccinated individuals than among unvaccinated individuals (0.48 versus 1.0 cases per 1,000 days), which subject to an efficiency of 53.6%.

Efficacy then increased over the following weeks and peaked during the sixth week after study recording.

How did the depth of disease compare between the two groups?

Among those who received the vaccine who tested positive for SARS-CoV-2, the 14-day hospitalization rate was significantly lower than among non-vaccinated people who tested positive, at 3.7% versus 9.2 %.

On the other hand, ICU entry rates were similar between the two groups, at 1.0% compared to 1.3%, as were 14-day mortality rates, at 0.0% versus 0.085%.

However, the team says it is worth noting that none of the vaccinated patients who developed COVID-19 have died, including 59 people who were followed for at least 28 days.

“Strong global effect” on vaccines

“Our data show a strong worldwide effect of COVID-19 vaccine equivalent to the results reported in all randomized trials,” wrote Soundararajan and colleagues.

“We stress that COVID-19 vaccines should be made available as widely and as quickly as possible to the public and that the effectiveness of the real world of these vaccines should be monitored as we move further. Phase 1a of the circulation process, ”the team concluded.

* Important message

bioRxiv publish preliminary scientific reports that are not peer-reviewed and, therefore, should not be seen as final, guiding health-related clinical practice / behavior, or be treated as information established.

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