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Pfizer and BioNTech Announce Their Covid-19 Vaccine Candidate is "90% Effective"

 The American pharmaceutical giant and its German partner BioNTech are the first to report positive results for a large-scale clinical trial of a vaccine against the new coronavirus.


Among the four major categories of vaccines developed against Covid-19, the one used by Pfizer had never been proven. DADO RUVIC / REUTERS


Good news that could be a game-changer on the Covid-19 front: a vaccine developed by Pfizer and BioNtech provides proof of “90%” efficacy , according to an announcement, Monday, November 9, from these pharmaceutical groups. But this hope remains to be confirmed.

“More than eight months after the start of the worst pandemic in more than a century, we believe that this step represents a significant step forward for the world in our battle against Covid-19,” said the Chairman and CEO of Pfizer, Albert Bourla, in a statement.

Richard Hatchett, CEO of the international coalition for the development of vaccines, has described as "historic" these intermediate results, "extremely positive and encouraging" . “We believe that these intermediate results also increase the probability of success of other Covid-19 vaccine candidates that use a similar approach ,” he noted.

 stage 3 study

These results come from the first interim analysis of a large-scale Phase 3 trial, the last before an application for registration. The phase 3 trial of the new vaccine, BNT162b2, began in late July in the United States, then in Germany, and has relied on 43,538 participants to date, 90% of whom have received the second dose of this candidate vaccine November 8.

In the clinical trial, 94 participants developed Covid-19, which made it possible to examine how many of them had received the vaccine and not the placebo, Pfizer explained. The pharmaceutical group did not specify how many sick people had received the vaccine. Nonetheless, an efficacy of over 90% implies that no more than eight of the 94 people who contracted Covid-19 have received the vaccine. The latter was given twice about three weeks apart.

The efficacy rate is much higher than that of 50% required by the Food and Drug Administration (FDA), the American health authority, for a vaccine against the coronavirus.

To confirm this rate of effectiveness, Pfizer announced that it would continue the trial until 164 cases of Covid-19 were counted among the participants. Given the recent surge in infection rates in the United States, this number could be reached in early December, said Bill Gruber, a chief scientist at Pfizer.

Data from the clinical trial has yet to be peer reviewed or published in a medical journal. Pfizer said it would do so as soon as it had the results of the entire trial.

The laboratory plans to apply to US authorities for an emergency use authorization of the vaccine for people aged 16 to 85. To do this, the group will need to have collected safety data for two months and about half of the 44,000 study participants. It is not yet clear whether the vaccine provides long-lasting immunity.

Procurement

Based on projections, Pfizer and BioNTech plan to deliver up to 100 million doses worldwide by the end of 2020, and around 1.3 billion doses by the end of 2021. To save time, companies started making the vaccine even before knowing if it would be effective.

The European Commission reached an agreement in September to obtain 200 million doses of the Pfizer-BioNTech vaccine, with an option for an additional 100 million doses. The laboratories also have supply agreements with the United Kingdom, Canada and Japan. And the US government, spearheaded by President Donald Trump, signed a $ 1.95 billion contract with Pfizer to deliver 100 million doses, should the vaccine ever be approved.

The vaccine supply for the European Union would be ensured by the production sites of Pfizer in Belgium and BioNTech in Germany. “At the same time, and in accordance with its commitment to fight the pandemic all over the world, Pfizer is in discussions with governments to anticipate the supply of the vaccine when it is approved,  ” says the laboratory.

The innovative messenger RNA techniqu

Among the four major categories of vaccines developed against Covid-19, the one used by Pfizer had never been proven. It is based on a new technology known as “messenger RNA”.

All vaccines have the same goal: to train our immune system to recognize the coronavirus, to raise its defenses in a preventive way, in order to neutralize the real virus if it were to infect us. Conventional vaccines can be made from inactivated (polio, influenza), attenuated (measles, yellow fever) viruses, or just proteins called “antigens” (hepatitis B).

But in the case of Pfizer and its German partner BioNTech, or Moderna, which uses the same technique but has not yet announced results, strands of genetic instructions called "messenger RNA" are injected into the body. that is, the molecule that tells our cells what to make. Every cell is a mini-factory of proteins, according to the genetic instructions contained in its nucleus.

The vaccine's messenger RNA is inserted and takes control of this machinery to manufacture a specific antigen of the coronavirus: the "spicule" of the coronavirus, its tip so recognizable which is on its surface and allows it to attach itself to human cells to penetrate them. This spike, harmless in itself, will then be detected by the immune system which will produce antibodies, and these antibodies will stay on guard for, hopefully, a long time.

The advantage is that with this method there is no need to cultivate a pathogen in the laboratory, it is the organism that does the work. It is for this reason that these vaccines are faster to develop. The downside of the latter: they must be stored at very low temperature. The US government has been putting in place the necessary logistics for several months. To date, no RNA vaccine has been approved for humans.

Soaring stock markets

The world stock markets were exulting on Monday and the European places ended very strongly after the announcement of Pfizer and BioNTech, which gives hope in the long term for a return to normal activity for many suffering companies.

Driven at the start of the session by the scenario of the US presidential election bringing Democrat Joe Biden to the White House, the markets took off after an announcement from the two laboratories around 1 p.m. (French time). The European markets then soared and remained ecstatic until the close: Paris took 7.57%, Frankfurt 4.94%, London 4.67%, Milan 5.43% and Madrid 8.57%. Paris, London and Milan posted their best single-session performances since March, and Frankfurt since May. The latter even briefly wiped out all of its annual losses, a first since the start of the health crisis among the major European stock markets.

The New York Stock Exchange's flagship index, the Dow Jones, closed up 2.95%, and the S&P 500, the most representative index of the US market, gained 1.17%. Pfizer shares soared 7.68%.

Speed ​​record

No vaccine has yet received approval for large-scale commercial distribution. But Chinese authorities have given the green light for emergency use for some of these vaccines.

According to the World Health Organization (WHO), ten vaccine clinical trials are currently in phase 3 worldwide, including those of the American biotech Moderna, several Chinese state laboratories and the British AstraZeneca, in collaboration with the university from Oxford. Pfizer and BioNTech are the first to release interim results from these trials.

In Russia, much of the political elite have said they've been vaccinated with the Sputnik V vaccine, which the government hopes to roll out massively in the coming months. At the end of October, the country submitted to the WHO a request for prequalification of this vaccine, “registered” by the authorities in early August, which in Russia corresponds to the stage prior to the final phase of clinical trials. A second Russian vaccine was registered in mid-October.

Pfizer was originally due to release these results at the end of October, but its CEO on October 27 called for "patience" , explaining that they were not yet ready. However, this would be a speed record for the development of a vaccine, less than a year after the appearance of the SARS-CoV-2 coronavirus in China.

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