Pfizer Says Coronavirus Vaccine Success, Predicts OK Emergency

• Pfizer’s experimental coronavirus vaccine has passed the final stage of clinical trials, the drugmaker said on Monday, a milestone in the company’s fight against the pandemic.
• Developing an effective vaccine against a brand new virus in less than a year is an unprecedented feat in the history of medicine.
• The study found that people who were injected with Pfizer were less likely to develop COVID-19, the disease caused by the novel coronavirus. The drugmaker said the vaccine has been shown to be over 90% effective in preventing COVID-19.
• Pfizer described the results in a press release. The trial is still ongoing and the interim results have not been published in a peer-reviewed medical journal.
• The vaccine will not be immediately available to people. It has yet to be evaluated by the Food and Drug Administration.
• For more stories like this, sign up for Business Insider’s daily health newsletter here.

A leading coronavirus vaccine candidate has worked to prevent people from developing COVID-19, a milestone in society’s war on the pandemic.

Pharmaceutical company Pfizer said on Monday that its vaccine had passed the last stage of clinical trials, which compared tens of thousands of volunteers who received two doses of the experimental vaccine to a group given a saltwater placebo.

The drugmaker said the vaccine was found to be over 90% effective in preventing COVID-19, based on 94 cases of the disease seen in the study.

Then, the New York drug giant plans to apply for an emergency authorization that would allow it to distribute the vaccine more widely. The company still needs more data on the safety of the vaccine before requesting the emergency, and said it would not have the information until later this month.

Pfizer and its German partner BioNTech are the first to report positive results from a pivotal trial of a COVID-19 vaccine. Developing and testing an effective vaccine in less than a year is an unprecedented achievement in medicine. Shares of Pfizer and BioNTech soared on Monday morning on the pre-stock market. Markets rose broadly on Monday, celebrating the vaccine’s success as a critical component in dealing with the pandemic.

Although the study is still ongoing and will collect follow-up data on safety and efficacy, the main finding from an interim review is that the vaccine is working.

“Today is a great day for science and humanity,” Pfizer CEO Albert Bourla said in a statement. “The first set of results from our Phase 3 COVID-19 vaccine trial provides initial evidence of our vaccine’s ability to prevent COVID-19.”

Questions remain, however, such as how long the vaccine works and whether there are any ultra-rare but serious side effects that have not yet been detected.

The impact of success will not be immediate on society. The main challenges are now shifting from the scientific domain to the regulatory, logistics and political domain. Regulators must review the data and decide whether or not there is enough evidence to approve the shots. Supplies will also be extremely limited during the first few months, as production is ramped up.

Pfizer’s vaccine will also pose unusual logistical challenges. It should be shipped and stored at -94 degrees Fahrenheit. The Centers for Control Disease and Prevention has estimated that the United States will have around 20 million to 30 million doses of Pfizer vaccine in 2020, which translates to doses sufficient to immunize less than 10% of the American population.

If the vaccine gets emergency approval, it won’t be available to everyone at the same time. The first people eligible for the vaccine may be those at high risk of getting sick, such as frontline health workers and the elderly.

Even when people start to get vaccinated, experts have stressed that it will be essential to continue to wear masks and to distance themselves socially.

While the study served its primary goal of reducing symptomatic COVID-19 cases, that doesn’t necessarily mean the vaccine prevents asymptomatic infection or serious illness.

This means that those vaccinated could still be unconscious carriers of the virus and could still be at risk of developing severe COVID-19 which requires hospitalization and can even lead to death. The longer-term data from the study could help answer these questions.

Read more: There are 176 vaccines against the coronavirus in the pipeline. Here’s how the major drugmakers see the race for a cure going in 2020 and 2021 and when the first injections might be available.

Initial results are limited, but Pfizer boasts strong efficacy

These results come from an interim analysis of the study, which is still ongoing. The trial will continue with its final analysis of 164 COVID-19 cases, which should help produce more rigorous results over time.

The trial recruited 43,538 volunteers, who were randomly given the vaccine or placebo injections. Researchers designed the study to count cases of COVID-19 among trial participants. Once a number of volunteers fell ill, an independent expert panel reviewed the data to see if those who received the experimental vaccine were much less likely to get sick than those who received the saltwater placebo.

The main goal was to see if the vaccine reduced cases of COVID-19 after receiving both doses. The testing protocol specified a case of COVID-19 as someone who both tested positive and exhibited symptoms. Researchers counted cases starting a week after the volunteer received the second dose. Pfizer said on Monday that protection against the virus was achieved 28 days after the initial dose.

There are no long-term follow-up data available for people who received the Pfizer vaccine. This means that critical questions about the durability of the shot protection as well as the risk of long-term side effects remain unknown.

The study will continue to answer these questions. Experts have noted that vaccine trials are rarely able to identify ultra-rare side effects, which can be events in a million. US health agencies have surveillance systems to track the efficacy and safety of vaccines after a vaccine is released to the public.

Read more: 5 experts explain how they’ll determine if a coronavirus vaccine is truly safe and effective – here’s what you need to know to assess the data for yourself

THIBAULT SAVARY / AFP via Getty Images

Pfizer gears up for rapid approval

Thanks to the Operation Warp Speed ​​coronavirus vaccine initiative, the US government has been preparing for success in the clinic for months.

The US government struck a deal in July with Pfizer to purchase 100 million doses for $ 1.95 billion. This contract also included an option to purchase up to 500 million additional doses. Pfizer has made deals with dozens of governments around the world, beyond the United States, allocating fragments of initial supply to many countries.

Read more: Trump’s Coronavirus Vaccine Tsar Told Us How Operation Warp Speed ​​Decided Which 6 Candidates To Support With Massive Multi-Billion Dollar Deals

In total, Pfizer plans to manufacture 50 million doses by the end of 2020 and up to 1.3 billion doses in 2021.

The US Food and Drug Administration will decide whether or not to approve the investigational vaccine. The agency is expected to quickly convene a panel of independent experts to review the data once Pfizer submits its request. Although Pfizer has said it should have enough safety data from the study by the third week of November to bring the vaccine up for review, it is not clear how fast the regulatory process will be. will evolve from there.

The FDA expert group usually holds a long public meeting to ask about the rigor of the data and the risks and benefits of approving an investigational drug. FDA scientists then consider the recommendations of this group and ultimately make an approval decision.

Typically, the agency takes six to 10 months to review requests for new drugs and vaccines. While it is widely anticipated that the timeline will be significantly accelerated given the urgency of the pandemic, a precise timeline is unclear.

Siphiwe Sibeko / Pool via AP

More results expected in the coming months for competing COVID-19 vaccines

While Pfizer’s vaccine is the first to report successful advanced trial results, several other drug developers aim to quickly track the results of their own vaccines.

Other pioneers are Massachusetts Moderna biotech, British pharmaceutical giant AstraZeneca and the University of Oxford, the world’s largest healthcare company Johnson & Johnson, and small Maryland biotech firm Novavax.

The vaccines developed by all of these drug makers have entered the final stages of clinical testing. Moderna plans to release its results in November, while AstraZeneca aims to have data before the end of the year. J&J and Novavax will likely have results a bit later, targeting the end of 2020 or the beginning of 2021.

Pfizer’s success should boost confidence in other vaccines, as all of these vaccines target the same part of the coronavirus: its spike protein. It is also the validation of a promising technology in vaccine research that has not yet been proven. Pfizer’s candidate is a messenger RNA (mRNA) vaccine, which only requires the virus’s genetic code to design an experimental vaccine.

The Pfizer reading is the first success in an efficacy study to show that the technology works in humans. Moderna also specializes in mRNA treatments and vaccines and was the world’s first drug maker to start testing a COVID-19 vaccine in humans in March.

Read more: Moderna’s untold story as a biotech coronavirus vaccine faces test that could make it one of the most important startups of all time