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How is the global vaccine research and development after the United Kingdom approves the launch of the coronavirus vaccine?

How is the global vaccine research and development after the United Kingdom approves the launch of the coronavirus vaccine?

“Science’s searchlight has found an invisible enemy.”

December 2nd local time, British Prime Minister Johnson commented after the British government officially announced that the coronavirus vaccine developed by Pfizer of the United States and BioNTech in Germany had been urgently authorized.

According to the Associated Press, the British Drug and Health Products Authority (MHRA) said that the vaccine has been proven to be safe and can be vaccinated on a large scale in the UK, making the first country in the West to approve the launch of a coronavirus vaccine.

The United Kingdom approved the emergency authorization of Pfizer vaccine. / Screenshot of Associated Press report

“I re-emphasize that public safety is always the first,” the MHRA CEO said, “This authorization comes after MHRA’s rigorous scientific evaluation of every single data.”

Matt Hancock, the British Health Secretary of State, said that the United Kingdom will receive the first batch of 800,000 doses of vaccine from Belgium in the near future, and people will start injecting them immediately after all the vaccines arrive, two doses per person at intervals of three weeks.

According to AFP, as of mid-November, World Health Organization (WHO) statistics show that a total of 49 “candidate vaccines” are in the stage of human clinical trials, of which 13 have entered the third phase of clinical trials and are being tested for their effectiveness on a large scale.

Now that Pfizer vaccine has been authorized, what is the development process of other vaccines around the world? What kind of vaccination plans have been developed by countries?” Foreign affairs” takes you to find out.

Moderna vaccine in the United States: children’s testing is planned

The Moderna vaccine is similar to the Pfizer vaccine, and is a ribonucleic acid vaccine (mRNA). Data show that the Moderna vaccine must be stored at minus 20 degrees Celsius, and the effective rate for adults is as high as 95%. According to AFP, on November 30, local time, Moderna Pharmaceuticals has applied for emergency authorization for vaccines in the United States and Europe. The European Drug Administration (EMA) said it would decide whether to approve the Moderna vaccine by January 12, 2021.

On December 2nd local time, Moderna Pharmaceuticals officially issued a statement that it would test the vaccine among 3,000 children between the ages of 12 and 17. Dr. Paul Offett, a vaccine scientist at Children’s Hospital in Philadelphia, noted that vaccines are “to a large extent” effective for both children and adults, but sometimes require different doses.

Moderna will begin testing vaccine effectiveness in children. / Screenshot of the New York Times report

The New York Times pointed out that the United Kingdom first allowed mass vaccination, which invisibly increased pressure on the U.S. drug regulator. On December 1st local time, Trump’s White House Chief of Staff summoned relevant officials to the White House to ask them to explain why the United States is not ready for mass vaccination.

One of the reasons is that the review mechanisms of the two countries are very different. British and European regulators rely more on corporate analysis, and unless there is an abnormal situation, they will directly use corporate documents as the basis for decision-making. Instead of directly accepting data from vaccine manufacturers, the U.S. drug regulator reanalyzes the raw data of the trial. On December 1 local time, Stephen Hahn, director of the Food and Drug Administration (FDA), said that the FDA is one of the few institutions in the world to view the raw data. The New York Times pointed out that on December 2nd local time, scientists and industry experts had a fierce debate over the two censorship mechanisms.

According to Reuters. FDA will convene an advisory committee meeting on December 17 local time to discuss the request for emergency authorization to produce a coronavirus vaccine.

Russia’s “Satellite V” vaccine: mass vaccination is coming soon

According to Bloomberg, on December 2nd local time, Russian President Putin said that Russia will start mass vaccination against the novel coronavirus next week. Putin noted that “[Russia] will produce more than 2 million doses of ‘satellite V’ vaccine in the next few days, and Russia’s vaccine production industry and medical network are ready for mass vaccination, and now it is time to take the first step.” Russian vaccination will adhere to the principle of voluntary people and receive vaccination free of charge.

The effectiveness of the Russian “satellite V” vaccine is 91.4%. /Twitter screenshot

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In early August this year, the Russian government approved the “Satellite V” coronavirus vaccine independently developed by the Russian “Gamaleya” research institute, and said it was the first officially registered coronavirus vaccine in the world. According to the Associated Press, the developer of the “Satellite V” vaccine said that the medium-term analysis showed that the vaccine was effective at 91.4% based on trial data from 18,794 study participants.

Although experts warn against widespread use of vaccines until all necessary tests are completed. On December 2nd local time, Russian Health Minister Mulashko said that so far, more than 100,000 people in Russia have been vaccinated.

AstraZeneca & Oxford University, UK: The test results are questioned

The vaccine developed by Oxford University and AstraZeneca is a “viral vector vaccine”. It can be stored at a conventional refrigerator temperature and is cheaper, but the vaccine is relatively ineffective.

On November 23 local time, Oxford University and AstraZeneca announced the results of the medium-term trial of the vaccine. Subsequently, this data was widely questioned. The Guardian reported that when injecting 2,700 volunteers, only half of the first dose was used in the first injection and the full dose was used in the second round, according to the Guardian. In this case, the vaccine is as effective as 90%, while the effective rate of two full doses is only 62%.

AstraZeneca’s coronavirus vaccine may undergo a new round of global trials. /Twitter screenshot

HHS officials pointed out at the meeting that unless AstraZeneca can clearly explain why the efficacy of the vaccine varies significantly between the two situations based on facts and data, it will be difficult for AstraZeneca to pass the vaccine.

As AstraZeneca’s coronavirus vaccine is facing questions about its effectiveness, the vaccine may undergo a new round of global trials to evaluate the efficacy of the vaccine, according to Bloomberg. Reuters pointed out that AstraZeneca may obtain data on its vaccine trials in the United States by the end of January 2021, and then apply for emergency authorization.

French Sanofi vaccine: Entering the human trial stage

According to the official website of Sanofi Pharmaceutical Company of France, in September this year, the coronavirus vaccine jointly developed by Sanofi and the British GSK Vaccine entered the human test stage. The test will recruit 440 volunteers to conduct randomized, double-blind and placebo-controlled trials to test volunteers’ tolerance to the vaccine. Resorability.

Sanofi and GSK initiate phase 1/2 clinical trials of recombinant protein candidate vaccines. / Screenshot of the official website of Sanofi Pharmaceutical Company.

Sanofi said that if the research progresses smoothly, the research and development of the vaccine will enter the final stage at the end of this year and prepare for mass production to go public. It is expected that the vaccine will be put into mass production in the first half of 2021, achieving an annual production of 1 billion.

According to AFP, on December 1 local time, French President Macron said that France plans to be vaccinated against the novel coronavirus on a large scale between April and June next year. Previously, France had initially vaccinated the most vulnerable people.

France is one of the most skeptical of vaccines, according to the French newspaper Sunday, and polls show that only 41% of French people plan to be vaccinated. Therefore, Macron reiterated that vaccination will not be mandatory.

Five vaccines in China enter the third phase of trial

On November 18, Chinese Foreign Ministry spokesman Zhao Lijian said in response to reporters’ questions, “So far, five vaccines in China are carrying out phase III clinical trials in the United Arab Emirates, Brazil, Pakistan, Peru and other countries, and many vaccines are stepping up the promotion of phase I and II clinical trials.”

Zhao Lijian pointed out that since the outbreak of the novel coronavirus epidemic, the Chinese government has laid out five technical routes: inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine.

He also said that the Chinese government and enterprises are not only involved in international cooperation on vaccines through multilateral and bilateral channels. China also maintains close communication and cooperation with the World Health Organization, the Global Alliance for Vaccines and Immunization, the Alliance for Epidemic Prevention and Innovation and other international organizations. China has also joined the “Coronavirus Vaccine Implementation Plan” to promote the equitable distribution of vaccines, ensure the provision of vaccines to developing countries, and at the same time drive more capable countries to support the “Implementation Plan”.

Japan and South Korea invest a large-scale budget to buy vaccines

According to Kyodo News Agency, the research and development of domestic vaccines in Japan is slightly slow. Only one pharmaceutical company in Japan, AnGes, has entered the clinical trial stage of the coronavirus vaccine.

However, Japan has reached agreements with Pfizer in the United States, Moderna and AstraZeneca in the United Kingdom. After the successful development of the vaccine, Japan will invest $6.4 billion in a budget to provide 145 million Japanese with enough vaccines.

On December 2nd local time, the plenary session of the Japanese Senate unanimously voted to adopt the revised Vaccination Law, which will bear the cost of vaccination against the Japanese people against the novel coronavirus, and stipulate that the Japanese people are obliged to receive vaccination, but if the effectiveness and safety of the vaccine cannot be guaranteed, there is no obligation.

The situation in South Korea is similar to that in Japan. According to South Korea’s edaily, South Korea’s coronavirus vaccine is still in the early stage of research and development. At present, only the “NVP2001” vaccine of SK Biosciences has been approved by the Korean Food and Drug Service to enter the first phase of clinical research.

According to South Korea’s Money Today report, on December 1 local time, the Central Disaster Safety Response Headquarters of South Korea said that the government plans to ensure 10 million vaccines by 2020 and conduct pre-order negotiations with international pharmaceutical companies entering the third phase of clinical trials. South Korea originally planned to purchase a coronavirus vaccine budget of 320 billion won, and then added 900 billion won to ensure 44 million vaccines. According to Yonhap News Agency, on December 3 local time, the South Korean government signed a contract with AstraZeneca for the supply of coronavirus vaccine.

WHO advances deployment plan

After Pfizer’s vaccine was approved in the UK, the WHO also tweeted that it is currently reviewing the vaccine trial data submitted by pharmaceutical companies, which will accelerate its access to the WHO emergency use list.

The WHO Emergency Use Inventory will allow countries to approve vaccines for national emergency use and allow the vaccine to go international through global buyers such as UNICEF.

WHO tweet. /Twitter screenshot

On November 13th, local time, the WHO Advisory Expert Group on Immunization Strategy released a road map for prioritizing the use of the novel coronavirus vaccine, guiding countries on how to divide the priority vaccination groups within countries and how to develop overall public health strategies in different epidemiological environments and vaccine supply stages.

According to the WHO website, so far, WHO has raised $8.1 billion to promote international exchanges and accelerate research cooperation. WHO also works with the Global Alliance for Vaccine Immunization and the Alliance for Innovation in Epidemic Preparedemiological Prevention to implement the COVID-19 Vaccine Implementation Plan (COVAX) within the framework of the International Cooperation Initiative of the Access Tool Accelerator to Combat COVID-19 to coordinate global vaccine development.

WHO pointed out that COVAX aims to accelerate the development and production of COVID-19 vaccine, and promises to provide 2 billion vaccines by the end of 2021. On August 24th local time, WHO Director-General Tedros Tedros said that a total of 172 countries had joined the COVAX program and agreed to have equitable access to safe and effective vaccines through joint international procurement of vaccines.

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