In October, authorities of the Ministry of Health announced  an agreement with the companies Pfizer and BioNTech
 for the purchase of the BNT162b2 vaccine against covid-19. - Pfizer photo -




































Published Tuesday, November 10, 2020

Pfizer vaccine against covid-19
achieved success phase III study



By the A.M. Costa Rica staff and wire services

Pfizer Inc announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against covid-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases.  Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections the company expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

In October, authorities of the Ministry of Health announced  an agreement with the companies Pfizer and BioNTech for the purchase of the BNT162b2 vaccine against covid-19.

According to the ministry, this vaccine is mRNA-based, patented by BioNTech and endorsed by Pfizer, and it will be produced after proving success from clinical studies and regulations.

The agreement is for 3 million doses. This will allow two vaccines to be applied to 1.5 million people, the government said in its statement.

The cost of these purchased vaccines has not been disclosed per commercial confidentiality agreement required by the companies, the government said. The National Emergency Fund is paying for the vaccines, with an estimate of receiving the treatment gradually in the first quarter of 2021. This depends on the clinical success demonstrated in these treatments.

This agreement joins the announcement of Costa Rica's adhesion to the COVAX-Facility mechanism, for the purchase of vaccines for more than one million people. With both agreements, there is an estimated 2.5 million people to receive the vaccine against covid-19.

However, between both agreements there are not enough vaccines to cover the entire population of the country. According to the Statistics and Census Institute, the population of the country is at approximately 5 million inhabitants.

The government is expected to announce the strategy for obtaining the vaccine for the remaining 50% of the population that is not included in these agreements.

The government joined the COVAX-Facility program coordinated by the World Health Organization, WHO.

In the case of COVAX agreement, the first advance payment of $6,316,560 or 30% of the cost was schedule to be made during October, the government said in its statement. The payment is based on the price that was set by COVAX at $10.55 per dose. The price includes factory costs, access, financing, risk mitigation and operating costs.

COVAX-Facility is led by GAVI-Alliance, which is a private non-profit foundation of the WHO, the United Nations Children's Fund is a United Nations, UNICEF, the Bill and Melinda GATES Foundation and the World Bank.

The COVAX program was announced in April by WHO, the European Commission and France. The collaborative effort focuses on the development of vaccines against covid-19 and has the participation of governments, WHO, manufacturers, scientists, among others.

According to the government, the country will have access to candidate vaccine doses as a result of advance purchase commitments. As the doses of the candidate and selected vaccines become available, the country will have the opportunity to purchase approved vaccines from the manufacturers.



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How is your government planning to purchase and disperse the covid-19 vaccine in the country?  We would like to know your thoughts on this story. Send your comments to news@amcostarica.com






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