BRUSSELS (Pakistan Point News / Sputnik - 06th June, 2020) After the cacophony around masks, tests and border closures, EU countries are now focusing on the next step, striving to develop a COVID-19 vaccine, or rather vaccines, and secure access to such a substance if someone else produces it first.
On Thursday, Handelsblatt newspaper reported that Germany is set to launch an alliance of four EU nations to ensure access to coronavirus vaccines for the bloc once they become available amid worries that China and the United States might secure control over large amounts of vaccines first.
German Health Minister Jens Spahn, together with his counterparts from France, Italy and the Netherlands, reportedly said in a letter to the European Commission that the development of a vaccine was one of the most pressing issues for the bloc.
Developing a vaccine is only half the problem. The production of billions of doses will demand time, and every country around the world is now jockeying for position to pre-pay pharmaceutical companies that have the expertise and capacity to do it. Such firms are sometimes separate from the laboratories developing the vaccines.
GSK, AstraZeneca, Johnson & Johnson and Sanofi are among the companies that will produce vaccines, whatever laboratories are going to come first with a vaccine.
Since the novel coronavirus was detected in China's Wuhan in late December, vaccine projects have been launched around the world. As of early April, there have been 115 such projects, with 73 of them already in pre-clinical development and five others in phase 1 of clinical development.
Most laboratories base their work on existing vaccines against different types of viruses. Normally, this would take five years, but now it is a race against time.
Laboratories try to get publicity by announcing that they are "nearly there," as France's Sanofi has done. So did British-Swedish pharmaceutical giant AstraZeneca working with Oxford University, so did an Israeli laboratory, Migal, in Galilee. So did an American biotech laboratory, Moderna.
Moderna is a typical example of these fast-growing hi-tech companies: the firm has lost money over the last nine years, but is valued $10 billion at the Stock Exchange.
In Germany, biotech company CureVac, headquartered in the town of Tübingen in the southwestern state of Baden-Württemberg, is very advanced in the development of a vaccine too, with the help of the German Health Ministry's Paul-Ehrlich institute. The US, which owns some shares of the company, reportedly sought to "reserve" the potential vaccine, with stirred a backlash in Europe. Later, the� firm dismissed such media reports, saying that the US had made no such offer. The company hopes to have an experimental vaccine ready in the summer and then seek a go-ahead for testing on humans.
In France, the government expressed concerns earlier in May over Sanofi CEO Paul Hudson saying that the United States has a right to the largest preorder of a potential vaccine because it had invested a lot.
Prime Minister Edouard Philippe warned that a Sanofi vaccine should be a "public good" and access to it must be equitable. President Emmanuel Macron even chaired a meeting with the Sanofi leadership to deliver it this message personally.
The European Commission immediately sided with Paris and took the same position, doubting that the rule of commercial law applies here.
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Experts explain that pharmaceutical companies are not only racing to develop a vaccine, but also gearing up for their mass production.
"The public does not fully understand that there are two important elements in the production of a vaccine: laboratory research and development of the vaccine first, and then mass production of vaccine doses, which can be intramuscular injection or aerosol. They are often different companies: the research and development laboratory and the producer of vaccine doses," Dr Jean-Luc Gala, epidemiologist and professor at the Catholic University of Louvain, told Sputnik.
According to Gala, it is possible that the EU will buy at a high price, given the cost of R&D, a patent for a vaccine and make it available to humanity, but "states will still have to pay for the production of billions of doses of vaccine which will be produced by private companies, the 'big pharma' in stride."
Thus, a huge market is "looming on the horizon" for the industry.
The professor dampens high hopes for a vaccine very soon, citing multiple technical steps that are needed to have it ready.
"Step 1 for the lab is to find the right antigens that fight the virus; they seek to identify and develop a virus surface protein, which triggers the patient's immune response. The second step is the most difficult, it is the coupling of this protein to clones of the virus (other less toxic coronaviruses, like the cold for example) to produce a sequence containing the weakened Covid-19 virus, against which we want to create immunity," Gala said.
The third stage, he went on, is a first phase of basic tests: on animals and cultures of human cells.
"We are talking about phases 0, 1, 2, 3 of the tests. First the Safety tests (absence of toxic reactions) on a small group of volunteers. Then we test on a larger group, the effectiveness of the antibodies generated and we check if there are any side effects. We also define what is the right therapeutic dose," the expert explained.
Many vaccines fail at this stage, Gala noted, because undesirable side effects emerge. Those successful move on a large-scale testing on large cohorts of patients, to compare the effects of the vaccine with a placebo.
"The first of these final tests should take place at the end of the year or early 2021. Clinical trials concern up to 30,000 participants ... The first vaccines will not be able to go into production until the spring next year. Not on the market before June 2021! So beware of announcement effects!" he warned.
A vaccine often becomes available when an epidemic ends and when it is no longer useful, except in case of resurgence of the virus later, which will be slightly different, as is the case with the influenza virus, which requires the vaccine to be adapted every year, the expert pointed out.
Epidemiologists still call for investing in basic research before a new virus comes, as the world has a new coronavirus almost every 10 years. SARS-CoV in 2002-2002, MERS-CoV in 2012 and now SARS-CoV-2. If we had developed prophylactic and curative treatments 10 years ago, we would be better prepared for fighting the novel coronavirus.
"The virus no longer clinically exists in Italy," Dr. Alberto Zangrillo, the director of the San Raffaele hospital in Milan, boldly said on Italian television on Sunday.
According to him, "the samples taken during the last ten days show an absolutely infinitesimal viral load compared to those taken a month or two ago".
In other words, recently infected patients have less strong virus than those at the start of the epidemic.
Another professor, Dr Matteo Bassetti, the head of the infectious diseases department at the San Martino hospital in Genoa, is also convinced that the strength of the virus two months ago is not the same as today." Could it be the first ray of hope? We cross our fingers.
The World Health Organization, however, warns of high risks of COVID-19 resurgence, adding that the second wave may be "truly devastating."
