Pfizer Announces Early Evidence of Effective Vaccine as COVID-19 Cases Increase

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California approaches 1 million cases, 11 counties move backwards in reopening plans

By Terry Miller

U.S. President-elect Joe Biden addressed the nation after meeting with his Transition COVID-19 Advisory Board on Monday, calling for unity and a national plan to contain the pandemic.

During a televised press conference from Wilmington, Del., Biden pledged to make rapid testing more widely available, “building a corps of contact tracers who will track and curb” the virus, and providing guidance and resources for schools and other economic sectors to reopen. The president-elect said it was “imperative” the U.S. also increase production of personal protective equipment. “Please, I implore you, wear a mask” he said.

This came on the heels of an announcement by Pfizer that they have very encouraging news that a vaccine candidate against COVID-19 has achieved a 90 percent success rate in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis, according to a press release from the pharmaceutical corporation.

“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.”

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, 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 two-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.

The study will continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“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.”

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 current projections they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

While the results of Pfizer’s research is promising, it’s important to note that this may not be “the magic bullet” so many have been hoping for, but merely some extremely encouraging and potentially good news to battle the deadly virus.

Pfizer says that it was not involved, nor was it part of President Donald Trump’s so called “Operation Warp Speed,” indicating than no federal money was used in the studies at Pfizer for this COVID-19 vaccine announcement.

According to a CNN report, after reporting 100,000 new coronavirus infections seven days in a row, the U.S. surpassed more than 10 million cases on Monday — more than any other country according to data from Johns Hopkins University.

Experts predict that the country could see 200,000 new cases a day if projections are accurate. On Tuesday, the U.S. reported more than 130,900 new cases and had more than 61,900 people hospitalized nationwide, according to the COVID Tracking Project.

As of Wednesday morning, there have been at least 977,218 cases and 18,001 deaths since the beginning of the pandemic in California, according to the state’s tracking website. “Over the past week, there has been an average of 6,423 cases per day, an increase of 43 percent from the average two weeks earlier,” according to The New York Times.

On Tuesday, 11 counties in California were moved to more restrictive tiers on the state’s coronavirus reopening blueprint while no counties were moved to a less restrictive one. California Health and Human Services Secretary Mark Ghaly warned that the state is in for a bumpy road ahead.

“We anticipate, if things stay the way they are, that between this week and next week, over half of California counties will have moved into a more restrictive tier,” he said. “And that certainly is an indication that we’re concerned, and we have to keep a close watch on what’s happening.”

Gatherings remain one common denominator driving this increased spread of the virus, a concern as the holidays quickly approach. Ghaly said that “almost each county that’s having increased transmission, they mention private household gatherings as a major source of spread.”

Los Angeles County has reported an average of 1,601 new coronavirus cases a day over the last seven days, an increase of 39.6 percent. Throughout this pandemic a surge in cases is followed by increases in hospitalizations and deaths, county health officials warned Tuesday.

“It is promising to hear the news of COVID-19 vaccine possibilities in the near future.  However, we cannot wait for a vaccine to slow the spread of COVID-19 in L.A. County,” said Barbara Ferrer, director of Los Angeles County Department of Public Health in a statement Tuesday. “Every person needs to make personal decisions each day to use the tools we know work. I ask that you encourage your family and friends to stay the course. The power to prevent more cases, hospitalizations and deaths is within all of us.”

November 11, 2020

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Terry Miller

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