Six African countries receive RNA technology for their anticovid vaccines

Six African countries – Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia – will receive the technology to produce their own messenger RNA vaccines, a key step in ending the global inequality in COVID vaccination.

A person protests in Cape Town (South Africa) for equal access to vaccines against covid. EFE/EPA/NIC BOTHMA

The Director General of the World Health Organization (who), Tedros Adhanom Ghebreyesusannounced the names of the six beneficiary countries of this initiative on vaccines in the framework of the European Union (EU)-Africa summit held in Brussels, and in the presence of the presidents of those nations, in addition to the French Emmanuel Macron and the European Commission, Ursula von der Leyen.

“They will be vaccines designed by Africa, owned by Africa, and with African leadership,” said Von der Leyen, who stressed that the EU, France and Germany have supported the project that has made this advance possible with an investment of 40 million euros. .

The initiative took its first steps last year with the creation of a research center on messenger RNA technology in Cape Town (South Africa), in which not only the EU, France and Germany have collaborated, but also Belgium, Norway and Canada.

Its goal was to develop its own mRNA technology, a new field for vaccine design that has achieved the most effective in the current COVID-19 pandemic: the drugs developed by Moderna and Pfizer-BioNTech were based on it, and showed the rates higher effectiveness against the coronavirus.

mRNA vaccines differ from traditional ones (normally based on weakened forms of the virus) in that they introduce ribonucleic acid (RNA) molecules that by themselves contain instructions with which the human body can produce the virus and at the same time the antibody that neutralize.

First African anticovid vaccine

The Cape Town center, which Tedros visited last week, has already managed to develop an anticovid vaccine similar to Moderna’s in the laboratory, although there is still a long way to go: clinical trials will begin this year, and even if they are developed with success may have to wait until 2024 for it to be available.

The center is run by a consortium that includes the South African vaccine manufacturer Biovac, the firm Afrigen Biologics (which developed the necessary technology) and the South African Medical Research Council.

The necessary training to develop the vaccine production centers in the six selected countries will begin in March, and although the fight against COVID-19 will surely be its first priority, the longer-term objective is to combat other diseases such as malaria, tuberculosis or AIDS.

Von der Leyen highlighted in this regard that currently only 1% of the vaccines administered in Africa are produced on the continent, but that with initiatives such as the current one, it is hoped that by 2040 that percentage will rise to 60%.

“It is not acceptable that Africa is always at the bottom of access to vaccines. We appreciate the donations, but they are not sustainable solutions and we want to empower ourselves », she added at the ceremony South African President Cyril Ramaphosa.

Queue to get vaccinated in Johannesburg (South Africa). EFE/EPA/Kim Ludbrook

Vaccines in Africa: only 20% immunized

Although more than 10,000 million anticovid vaccines have already been administered in the world, with which more than 60% of the global population has received at least one dose, the distribution is very unequal.

While developed countries have very high vaccination rates and many of their citizens have even received booster injections, in Africa 80% of the population has not received a single dose.

“We have many tools to combat COVID-19, the great tragedy has been that millions of people have not yet benefited from them,” lamented Tedros, who recalled that 116 countries in the world are still far from achieving the great goal of achieving by mid-2022 that 70% of its population is vaccinated.

Although today’s announcement is important, Ramaphosa recalled that there are other ways to fight inequality in the pandemic, such as the suspension of vaccine and treatment patents that his country and India have been defending since 2020 before the World Trade Organization (WTO). .

Dozens of countries have joined the Indo-South African request, but an agreement has not yet been reached due to the reluctance of countries that are the headquarters of large pharmaceutical companies, as is the case of many in the European Union, Japan or Switzerland.

“With today’s initiative we limit the benefits of companies but at the same time we protect the precious asset that is intellectual property, we have to find a bridge between both things,” said Von der Leyen

MSF values ​​the decision but asks for greater involvement of Moderna

Doctors Without Borders appreciates the WHO’s decision but urges Moderna to help the Cape Town center to shorten production times and recalls that its vaccine was financed with public funds.

According Kate Stegeman, MSF Access Campaign Advocacy Coordinator For the Africa region, “This announcement marks a positive milestone on the path to expanding vaccine manufacturing capacity in low- and middle-income countries.”

In a statement, MSF highlights that the center’s research and development partner, the South African company Afrigen Biologics and Vaccines, has recently succeeded in producing microliter batches of an mRNA vaccine based on the publicly available sequence of the vaccine from the American pharmaceutical corporation Moderna. .

“And it has succeeded despite the lack of help from Moderna even though its vaccine has been financed, to a large extent, with public funds. The timeframe for the center to produce a final mRNA vaccine and eventual technology transfer to manufacturers is considerable, but could be shortened significantly if Moderna were to provide technical assistance to the center.”

The medical organization believes that many more advances are needed, such as developing a more heat-stable version, conducting clinical trials, and developing a large-scale manufacturing process. Thus, MSF urges Modernawhose vaccine is the most similar to the one designed by Afigen, to provide technical assistance to the center to shorten production lead timesNo of the vaccine.

“Although the hub is certainly an important initiative now and for future pandemic responses, the fastest way to start vaccine production in African countries and other regions with limited vaccine production remains the full and transparent transfer of vaccine know-how from already approved mRNA technologies to companies with existing capacity that can be retrofitted to produce mRNA vaccines,’ he says.

“We are entering an era of pandemics and the focus must be on vaccines”

Graziella Almendral presents in “Vacunas” (Ed. Urano) a complete perspective on present, past and future pandemics and everything that surrounds the world of vaccines.

Since the outbreak of covid, almost two years ago, science parked other work to investigate a vaccine against the new virus.

In December 2020, the first vaccine, from Pfizer-BionTech, was approved in record time. However, the race to find a suitable immunization method has not stopped.

EFEsalud speaks with the journalist to get a little closer to the scientists or “warriors”, as she calls herself, who lead the investigation against the coronavirus and the discoveries that have led us to current immunization methods.

What does your book contribute to the debate on vaccines and immunity against covid?

I think the book Vaccines offers scientific information told in a very informative way, about everything behind the appearance of a vaccine from the original idea in the mind of the person who created it.

For this reason, I wanted to put the vaccines with their protagonists, the men and women scientists, who have created them. And also see what has motivated them to generate a vaccine, what they have faced and the scientific knowledge behind it.

Many times they have had to face their own environment and the ignorance that existed at that time. Approaching that knowledge and those protagonists, I believe that many people are going to discover everything that is behind the appearance of a vaccine.

Many times it is thought that everything is the business of some companies, that I am not saying that they do not do business, but what is behind it is pure science, knowledge and commitment.

I do not think that a person who is against the vaccine will read it, but a person who is curious to clarify concepts will find clarity, knowledge, outreach and also adventure in this book.

Do you think the scientific community will be taken more seriously after the pandemic?

I am critical of this because I believe that the vast majority of society had prior recognition of the scientific community.

This was pending on the part of the governments and the political class, very far from science because they have not promoted it for decades, especially in a country like Spain.

And I hope that the visibility that is being given now is the push they needed to put the scientific community where it deserves to be. We owe everything to them and to the health workers and that is what I think the pandemic is going to do.

What has been the role of politicians during these two years of pandemic?

They have understood what the role of science was and they have understood that without it we would not have vaccines for the time being. I don’t know if out of personal belief, but certainly out of commitment and visibility they are going to start betting much more on science.

I hope so, but I am not yet convinced because we have a huge lack of commitment to science in Spain because it is not given the means it needs. A lot of infrastructure is needed and above all, a fixed, continuous and thought-out commitment in the short, medium and long term.

Only with short-term measures to win elections we are not going to solve the problem of science because we have to recover the great scientists who left and who cannot return. So I hope the pandemic is the beginning of historic debt relief.

Photo courtesy of Editorial Urano

How can you combat anti-vaccines from journalism and win the pulse of fake news?

The most important thing is transparency and the way the information is reported by the media, but especially by the health authorities.

We need to see the face and resume of all the people who are making the decisions. We need to understand that decisions must be based on scientific evidence.

You have to fight fake news with good information.

In Spain we do not have a strong anti-vaccine problem. We have another problem that is people who do not get vaccinated, not so much because of anti-vaccines, but because of complacency with this pandemic or because they have doubts.

In that sense, I hope that the book helps to understand that vaccines have been with us for many years and understand the procedure of how a vaccine is approved and that behind each of the vaccines that we are seeing now there are many years of research and there is no nothing improvised.

Are we going to have to get vaccinated every year?

Scientists don’t know. We must also understand that science has its times and that it has given us an impressive thing, which is to obtain many vaccines in less than a year. And we also already have new antiviral treatments that have been researched for decades and are now getting approved.

Knowing how the immune system will respond to new vaccines and what the duration of immunity is, we do not yet know.

We do know that each new variant that has appeared, especially omicron, has lowered the antibody response and that has indeed been important because it has caused us the reinfections that we are seeing now, but clearly we are already going to booster doses .

Ómicron has changed the landscape. In some cases in a very positive way and in others it has reminded us that we need to update vaccines. They are going to fight for a much more global vaccine that is not as specific as the one we have now, but against all the variants of coronavirus.

Graziella Almendral, president of the National Association of Health Informants (ANIS). Photo courtesy of ANIS.

What do you think about the vaccines that are being developed in Spain?

My big bet is the vaccine led by Luis Enjuanes. I think it will be the great vaccine. Enjuanes is one of the best coronavirus experts in the world. He has been studying viruses for 30 or 40 years together with the rest of his team.

It is a vaccine that has the vision of giving much more global immunity against the virus. With small doses it will have a wide spectrum and it is a vaccine that, if achieved, will be administered intranasally. Therefore, it will immunize the mucous membranes, the gateway of the virus to the body.

This will allow us to avoid infection and transmit the virus. I hope it is the great vaccine. If we are able to support them because we are late. We need to support them as a country.

Do you think we are prepared to face future pandemics?

Not quite yet. In Spain we have faced a lack of coordination between the autonomous communities when establishing measures that have greatly confused the population.

One of the most important elements is international coordination, such as the European Union has done, leading the purchase of vaccines and I wish that this had been done worldwide so that everyone had access to vaccines. If we had done it globally, the pandemic would be something else right now.

Although we are missing something essential, strengthening the health system because we are seeing how it is collapsing and we are not strengthening it.

The World Health Organization has established five priorities to defend ourselves against future pandemics, including strengthening primary care, and we are doing just the opposite.

What do you think about patents?

I would like that there is no need to release a patent, but that whoever manufactures the vaccines understands that in a pandemic and profit is behind it. The priority is to have vaccines for everyone.

In addition, it is not only producing vaccines, but allowing someone else to produce it and to do that you have to transfer the knowledge.

Once we end the pandemic, this accessibility can be closed, but in a pandemic the priority is to end it by vaccinating the entire population.

In some countries, 10% of the population has been vaccinated, while in others it has reached 80 or 90%. That inequality is causing two pandemics right now.

in your book Vaccines you talk about a single health, what does it consist of?

I always have my head set on the rest of the countries, what we can call “global health”. Attending to all conditions is a challenge to achieve. I put the focus on vaccines and understand that health is a single health.

Human health cannot be separated from animal health or the environment. If we believe that human health is going another way, we will never end infectious diseases.

Every time the Earth warms one tenth affects human and animal health. This is for me the great learning of the pandemic. We are entering the age of pandemics and one after another is going to come to us. The priority must be to take care of the Earth, the animals and ourselves.

It is not sustainable to administer several doses of vaccines in the short term

The European Medicines Agency (EMA) and other international regulators reiterated this Friday that the administration of several doses of vaccines against covid “at short intervals is not a sustainable approach” in the long term.

Vials of vaccines against covid. EFE/EPA/NARENDRA SHRESTHA

EMA: It is not sustainable to administer several doses of vaccines in the short term

The EMA and these organizations believe, however, that “the need is becoming clearer” to administer booster doses to extend the protection of COVID-19 vaccines.

These ideas are part of a report published this Friday on the conclusions of a meeting held last week of drug regulators from different regions, co-chaired by the EMA and the United States Food and Drug Administration (FDA).

In the document, the agencies urged to “develop a long-term strategy” on the types of vaccines needed to manage COVID-19 in the future.

“In discussing potential vaccination approaches against omicron and other variants of the virus, meeting participants agreed that giving multiple booster doses at short intervals is not a sustainable long-term approach,” they add.

Participants included experts from the World Health Organization (WHO), the European Commission, South Africa, and Israel, among other countries, who acknowledged that vaccines offer less protection against contagion and mild COVID-19, but are effective against hospitalization and severe illness with omicron, especially after the booster dose.

“It is becoming increasingly clear that a booster dose is needed to extend the protection of the vaccine,” they consider.

The long-term strategy debate is “an ongoing global debate,” acknowledges the EMA, which underlines that this discussion “is at the crossroads of science, public policy and public health” and will require coordination between public health authorities at all levels.

Regarding the composition of the updated vaccines, drug regulators urge the international scientific community and pharmaceutical companies to “seek alternative approaches to monovalent vaccines”, exploring the feasibility of developing bivalent or multivalent vaccines that can neutralize other variants of interest in the future.

In any case, they emphasize that any vaccine with an adapted composition must undergo clinical studies to support its safety, quality and efficacy before being approved for use in mass vaccination campaigns.

“These studies should be designed to show that the immune response, measured as neutralizing antibodies, generated by the updated vaccine is superior to that achieved with current vaccines. The ability of the updated vaccines to cross-neutralize other variants of interest would be an additional feature.”

Marco Cavaleri, head of Vaccination Strategy, warned on Tuesday that if it is necessary to vaccinate again in the future, at least to risk groups, the reinforcement could be offered with the arrival of the cold, as is already done with the flu, because “this would increase the antibody response when we need it most,” as opposed to consecutive doses.

“The repeated administration of boosters with several short time intervals could reduce the level of antibodies that can be produced in each administration, since our immune system needs a certain amount of time to show the response to the antigen that is presented to it. This will potentially make vaccination a little less efficient over time.”

The nocebo effect of the symptoms of anticovid vaccines

Sometimes, placebo effects can also be harmful, it is what is known as the nocebo effect. According to a large analysis using volunteer data from 12 clinical trials, more than two-thirds of adverse symptoms from covid-19 vaccines were due to them.

The symptoms of covid vaccines can also be due to the nocebo effect, according to a study. EFE/Jeffrey Arguedas

The nocebo effect of the symptoms of anticovid vaccines

The placebo effect is the supposed improvement in a person’s physical or mental health after a treatment with no pharmacological therapeutic benefit, a sugar pill or a syringe filled with serum, and it has an opposite version, the nocebo, which occurs when an individual experiences unpleasant side effects after also receiving this “lie treatment”.

The exact biological, psychological and genetic underpinnings of why they occur -placebo/nocebo effect- are not well understood, although there are theories that point to expectations as the main cause and others maintain that unconscious factors embedded in the doctor-patient relationship automatically lower the volume of symptoms.

To verify its role in covid-19 vaccines, the team from the BIDMC center, associated with the medical school of Harvard (EE.UU.), conducted a meta-analysis of 12 clinical trials.

The objective was to compare the rates of adverse events reported by the participants who received the vaccines with the rates of those who received a placebo injection – without any vaccine. The results are published in JAMA Network Open.

The 12 trials included reports of adverse events from 22,578 placebo recipients and 22,802 vaccine recipients.

nocebo effect, placebo effect

Although the scientists found that significantly more participants who received the vaccine reported adverse events, almost a third of the participants who received the placebo also reported at least one, with headache and fatigue being the most common.

Specifically, Julia W. Haas and her colleagues at the BIDMC found that after the first injection, more than 35% of placebo recipients experienced systemic adverse effects -symptoms that affect the entire body, such as fever-, the pain being headache and fatigue the most common, with 19.6% and 16.7%, respectively, the center reports in a statement.

16% of placebo recipients reported at least one local effect, such as injection site pain, redness, or swelling.

Haas reminds that adverse events after placebo treatment are common in randomized controlled trials.

“Gathering systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide, especially as concerns about side effects are reported to be a reason for vaccine hesitation.” .

Compared to the placebo group, after the first injection, 46% of vaccine recipients experienced at least one systemic adverse event and two-thirds of them reported at least one local one.

Although this group received a pharmacologically active treatment, some of their adverse events are attributable to the placebo effect – or in this case, nocebo – since many of these effects also occurred in the placebo group, the researchers say.

The analysis suggests that nocebo accounted for 76% of all adverse events in the vaccine group and nearly a quarter of all reported local effects.

After the second dose, adverse effects in the placebo group decreased to 32% for systemic cases and 12% for local effects.

In contrast, participants who received the vaccine reported more side effects, with 61% systemic adverse events and 73% local adverse events.

The researchers calculated that nocebo accounted for nearly 52% of reported side effects after the second dose.

Ted J. Kaptchuk, another of the signatories, explains that “non-specific symptoms such as headache and fatigue – which we have shown to be especially sensitive to nocebo – are among the most common adverse reactions after vaccination in many information leaflets” .

Evidence suggests that this type of information may cause people to mistakenly attribute common everyday sensations as being from the vaccine, or cause anxiety and worry that make people hyper-alert to the bodily sensations of adverse events.

“Medicine is built on trust,” Kaptchuk stresses: “Our findings lead us to suggest that informing the public about the potential for nocebo responses could help reduce concerns about covid vaccination, which could decrease hesitancy.”