AstraZeneta's new crown vaccine has revived the UK trial of a global vaccine research and development competition

On September 12, at 14:20 bST (UK Daylight Saving Time), a clinical trial of the new crown vaccine AZD1222 has resumed in the UK after safety confirmation by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA).
, however, clinical trials in other countries have not yet resumed and AstraZeneta will continue to work with health authorities around the world to recover in due course under guidance.
(Figure 1) Chart 1. AstraZeneza's new crown vaccine AZD1222 Clinical trials worldwide Source: AstraZenecom, clinicaltrials.gov, China Health Industrial Capital Research Centre, September 6, a British woman who developed a serious adverse reaction to a candidate vaccine AZD1222 in a clinical study (COV002), followed by a standard review procedure that triggered a proactive suspension of all global trials to allow independent committees and international regulators to review safety data.
committee in the UK recommended to the MHRA that it would be safe to resume testing in the UK after completing its investigation.
as the organisers of the trial, AstraZeneta and Oxford University were unable to disclose further medical information,' AstraZeneta said in a statement on its website on September 12.
all trial researchers and participants will be updated and disclosed in the global clinical trial registration, based on clinical trials and regulatory standards.
with the resumption of clinical trials in the UK, AstraZeneta's CEO told a press conference that it was still possible to meet its target of submitting clinical trial data by the end of the year and then obtaining a listing by the end of the year or early next year.
Swaminathan, chief scientist at the World Health Organization, said the suspension of AstraZeneta's new crown vaccine did not cause unnecessarily concern at WHO, but rather a reminder of the ups and downs of international medical research and development.
thinking after the clinical suspension of the new crown vaccine, with the joint efforts of the people of the whole country, China has taken the lead in controlling the new crown epidemic in the world and entered a low-risk "post-epidemic era".
, the new crown epidemic abroad is still raging, not only in Europe and the United States did not significantly ease, but also in Latin America, India, Russia and other regions and countries are becoming more intense.
according to the World Health Organization, as of 21:28 BST on September 14, 2020, there were nearly 29 million confirmed cases of neo-crown pneumonia worldwide, of which more than 920,000 died.
confirmed cases of new coronary pneumonia in the United States, India, Brazil and Russia exceeded 1 million, with some 6.42 million, 4.84 million, 4.31 million and 1.06 million cases, respectively.
Chart 2. Global New Crown Pneumonia Outbreak (as of 21:28 on 14 September) Source: The global pandemic of the New Coronavirus of the World Health Organization and the China Health Industry Capital Research Center has led to a sustained global economic downturn, and the plight of the economic base has intensified various social and political problems and contradictions.
background, the release of safe and effective new crown vaccine as soon as possible has become the key to control the epidemic and restart the global economy, and has won the attention of governments.
a press conference on the evening of September 4th, US President Donald Trump said the new vaccine would be available one day in October.
, the U.S. Centers for Disease Control and Prevention (CDC) urged health authorities across the U.S. to develop a vaccine distribution plan no later than October 1.
health experts such as Anthony Fauci, an American virologist, worry that the FDA is under political pressure to license a vaccine until clinical trials are complete.
global market demand for new crown vaccines is evident in global outbreaks and statements by individual governments.
economic interests and political factors, in order to pre-market the new crown vaccine, there is likely to be a violation of scientific principles.
to allay concerns about the politicization of the new crown vaccine, nine pharmaceutical companies that are developing the new crown vaccine have signed a pledge to preserve the integrity of the scientific process and ensure that the vaccine meets stringent approval standards.
signed the pledge from AstraZeneca, BioNTech, GSK, J and J, Merck, Moderna, Novavax, Pfizer and Sanofi.
signed a commitment, but then AstraZenecom's new crown vaccine Phase III clinical suspension reflects a lack of transparency.
Astrain did not report adverse reactions in a timely manner, causing the global clinical trial to be suspended on September 6th, until September 8th, when it was exposed by the US STAT website, and issued a statement on the company's official website suspending the trial on September 9th, and no specific adverse reactions were officially disclosed.
Pfizer's propaganda is also false.
BioTech, a German biotech company with Pfizer, announced on September 12th that phase II/III clinical trials (NCT04368728) would recruit 30,000 participants next week and planned to recruit an additional 14,000 to increase the diversity of the trial population, including adolescents as young as 16 years of age, chronically stable HIV infections, HCV or HBV infections.
Pfizer CEO Albert Bourla has repeatedly said he will clarify the effectiveity of the BNT162 mRNA vaccine by the end of October, a time that is in line with Mr. Trump's proposed time to market, but it is almost impossible to complete additional recruitment and obtain clinical data in the remaining six weeks.
(Figure 3) Chart 3. Pfizer and BioNTech's new crown vaccine "speed of light" development source: BioNTech's official website, The Global Leader in the Global New Crown Vaccine Research and Development Competition at the China Health Industry Capital Research Center, and pharmaceutical companies are racing against time to develop the new crown vaccine at an unprecedented rate, sparking a debate about this overly aggressive high speed.
35 vaccine candidates worldwide are in clinical stages, according to a panoramic view of the world's development of candidate new crown vaccines released by the World Health Organization on September 9.
new crown vaccine will undoubtedly have a significant impact on market share if it leads the market and gains a first-mover advantage.
, on the other hand, several approved new crown vaccines may be needed to meet the huge initial demand in the market.
, companies such as Merck and Co have deliberately opted for a steady approach, not being too aggressive in their research and development speed.
following introductions to several new crown vaccines that have clearly entered Clinical Phase III trials and are about to reach the end of the research and development competition.
Pfizer/BioNTech's BNT162b2 Funding: $1.95 billion in the United States; 750 million euros in Germany: 30 million doses in the United Kingdom; 120 million doses in Japan; 200 million doses in the European Union, another 100 million doses selected; and clinical I/I/Canada not disclosed Phase II: No Serious Side Effects; Antibody Response; T-Cell Response Clinical Phase III: Starting in July, 30,000 participants were recruited in the United States, Argentina, Brazil, and Germany: Pfizer and BioNTech surveyed four candidate mRNA vaccines, two of which were FDA fast-track qualified.
candidate, BNT162b2, entered Phase II/III trials at the end of July.
BioNTech is also developing the vaccine in China with Fosun Pharma.
may be priced at $19.50 per dose and is expected to produce 100 million doses this year and 1.3 billion doses next year.
: On August 28th the two companies announced that they would recruit more than 11,000 participants this week.
12 September, it announced another expansion of 14,000 (see above).
August 26, Fosun Pharma announced that BNT162b1 in China Phase I trial results are good, BNT162b2 has submitted a clinical trial application to the State Drug Administration, and communication on how to carry out bridding trials, bridge trials and foreign Phase III clinical completion.
Moderna's mRNA-1273 funding: $959 million for research and development orders in the United States: 100 million doses in the United States, $1.525 billion in Clinical Phase I/II: High doses with some serious side effects; Rapid Antibody Response Clinical Phase III: Starting July 27, 30,000 cases recruited in the United States Background: Early clinical data show that participants who are vaccinated have more antibodies than those who recover from the new coronavirus.
Lonza to produce 5-1 billion doses per year starting in 2021.
for small orders, the price per dose of vaccine is $32-37, and for 100 million U.S. orders, the discount is $15.25.
progress: On August 28th, the company expects to complete the Clinical Phase III trial in September, with data available by the end of the year.
new interim Phase I data show that in the three age groups of 18-55, 56-70, and 71 plus, the vaccine scores were consistent at 100 μg doses, and the level of moderate antibody was observed in all participants.
AstraZeneca's AZD-1222 funding: $1.2 billion in the United States; $750 million in CEPI and GAVI; 65.5 million pounds in the United Kingdom; $127 million in Brazil; 750 million euros in Orders from Germany, France, Italy and the Netherlands: 1 billion doses from the Indian Blood Institute; IVA4 in Europe 100 million doses; Clinical Phase I/II in Japan: Some moderate side effects; weak response to antibodies in participants exposed to adenovirus and single injections only; T-cell response Clinical Phase III: 50,000 cases recruited in Brazil, the United Kingdom, the United States and South Africa starting in July: in early tests, vaccine-induced antibodies and T-cell responses.
2 billion doses, mainly next year, and plans to sell vaccines widely and without profit.
: On September 6th, global clinical trials were suspended.
12 September, clinical trials resumed in the UK and trials in other countries await.
Sinopharma Inactivated Vaccine Funding: China's State-owned Clinical Phase I/II: Clinical Phase III begins in April: 15,000 participants were recruited in Abu Dhabi, United Arab Emirates, in July: In the Clinical Phase I/II trial, the candidate vaccine produced by the Wuhan Institute of Biological Products was used, and all patients who were injected with level 2 vaccine 2 days apart developed an immune response.
expected the vaccine to be approved by the end of the year, producing up to 200 million doses a year.
latest developments: An interim analysis of an I/II trial showed that the vaccine induced an immune response and that participants did not experience serious side effects.
most of the vaccinated participants under the study had serum transformation, and longer intervals between the first and second vaccinations led to higher antibody responses.
15 percent of the participants reported mild side effects, most commonly pain and fever at the injection site.
Sinovac's CoronaVac funding: Of the company's $140 million investment in the vaccine, the Chinese government contributed part of Clinical Phase I/II: No Serious Side Effects;
and Brazilian immunobiology manufacturer Instituto Butantan signed an agreement in June to advance clinical trials to Phase III.
can manufacture up to 100 million doses per year.
: CoronaVac, the inactivated vaccine for Coxing Bio, was added to emergency use programs in China in July and is scheduled to be used by medical professionals and border inspectors.
CanSino's Ad5-nCoV Clinical Phase I/II: No Serious Side Effects; Antibody Responses, but Weak Responses in Older Adults and People Already Exposed to Adenovirus; T-Cell Response Clinical Phase III: Plan to Recruit 40,000 Cases in Russia, Brazil, Chile and Saudi Arabia: China's First Candidate for Human Trials.
On June 25, the Health Bureau of the Ministry of Logistics and Security of the Central Military Commission issued a special needs drug approval for the military, approving the new crown vaccine for adenovirus vectors developed by the Chinese Academy of Military Sciences in cooperation with Consino Bio for use within the armed forces for one year, but not to expand the scope of vaccination.
: On September 3rd, Concino teamed up with Russian biopharmaceutical company Petrovax to begin a Phase III trial in Russia, with an estimated 40,000 volunteers.
was detained by Canadian customs for testing candidate vaccines, Concino abandoned clinical Phase I/II trials in Canada.
political tensions between the two countries may have contributed to the problem.
Gam-COVID-Vac Funding from Gamaleya Research Institute: Ministry of Health of the Russian Federation, Russian Direct Investment Fund, Sistema PJSF, Total Unknown Clinical Phase I/II: Starting in June, Test candidates for the vaccine Gam-COVID-Vac and freeze-dried agents Gam-COVID-Vac Lyo, two trials in Russia involved 38 participants in Clinical Phase III: the Gamalea Research Center in August conducted the equivalent of Phase III clinical trial background: Russia based on Phase I/II clinical trial data approved this adenovirus vector vaccine.
Russian President Vladimir Putin announced in the state news media that his daughter had been given the newly approved vaccine.
because the vaccine has not yet completed Phase III clinical trials, countries around the world remain questionable about the safety and effectiveness of the vaccine.
latest developments: On September 4, the vaccine was safe in 76 volunteers, and antibodies were detected in all participants, according to early clinical Phase I/II trial data published in The Lancet.
also found T-cell responses, with both CD4-plus and CD8-T cells proliferating.
speed of the new crown vaccine, which is safe and effective, will ultimately determine when this pandemic, which has killed nearly a million people and profoundly affected the progress of human history, can be contained.
on the one hand, we hope that the new crown vaccine can be launched as soon as possible, on the other hand, the existing technology and research and development model is restricted