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Posts tagged as “vaccine”

United Kingdom approves Pfizer’s COVID-19 vaccine, safe for use “next week”

December 2, 2020

UK just approve the Pfizer and BioNTech coronavirus vaccine for widespread use. BBC reports that “British regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe for roll out next week.”

Pfizer first reported that their mRNA-based COVID-19 vaccine was 90% effective against the coronavirus then later released an update that the vaccine is “95% effective against COVID-19 beginning 28 days after the first dose.

UK government already ordered 40 million doses – which is enough to vaccinate 20 million people, with two shots each. The first 800,000 doses will be arriving in the country in the coming days and fifty (50) hospitals are on standby and vaccination centres in venues such as conference centres are being set up in preparation for mass immunizations.

Last week, Pfizer release a video thanking all the participants in their COVID-19 vaccine trial, which is a crucial part in developing the their mRNA-based COVID-19 vaccine.

Source: BCC, Rappler

Moderna announces that its COVID-19 vaccine is 94.5% effective

November 17, 2020

US-based Moderna just announced that their COVID-19 vaccine, the mRNA-1273 have been found to be 94.5% effective, after its Phase 3 study, which the company is calling the COVE study. Moderna’s COVE study, have more than 30,000 participants in the U.S.

Similar to Pfizer’s COVID-19 vaccine, which was reported to be 90% effective, Moderna’s vaccine candidate is a two-dose vaccine that needs to be administer 28 days apart. Base on their reports, 95 out of 30,000 participants, have been tested positive for COVID-19, 90 cases of COVID-19 were included in the placebo group, while the other 5 cases are those who received mRNA-1273 vaccine.

Within the 90 cases in the placebo group, 11 are severe cases. Moderna futher brokedown the 95 cases which includes 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

Moderna classed the side-effects of the vaccine as mild or moderate; On the first dose, 2.7% participants had injection site pain classed as severe; after the second dose, 9.5% of participants experience fatigue, 8.9% experience muscle pains, 5.2% have joint pain, 4.5% experience headache, 4.1% felt pain and 2% had redness of the skin at the injection site.

In a separate announcement, Moderna said that their mRNA-1273 vaccine will remain stable for 30 days at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator. It can be stored for 6 months in storage at -20° C (-4°F), 30 days in a refrigerated conditions and up to 12 hours at room temperature conditions.

Moderna will submit the findings of their Phase 3 COVE study for a peer-reviewed publication and are currently seeking regulatory approval.

Pfizer’s COVID-19 vaccine is 90% effective from its Phase 3 clinical trial

November 9, 2020

This is a press release by Pfizer and its partner BioNTech regarding the first results from Phase 3 clinical trial, which began last July 27 with 43,538 participants. Their mRNA-based vaccine candidate, BNT162b2, against COVID-19 has been found 90% effective in participants in their Phase 3 clinical trial. Pfizer’s COVID-19 vaccine is a 2-dose vaccine, which are applied in 7 days interval.

Pfizer expect to supply up to 50 million vaccine doses by the end of 2020 and manufacture 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.

Here’s the full text of the press release;

NEW YORK and MAINZ, GERMANY, November 9, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today 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 seven 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 continues 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.”

“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech Co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

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 supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture 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.