Merck Sharp & Dohme Farmacêutica Ltda. (MSD) presents this Friday (23/9) at the National Commission for the Incorporation of Technology in the Unified Health System (Conitec) an appeal against the decision to deny the incorporation of the antiviral molnupiravir for the treatment of patients with Covid-19.
In an interview with JOTA, the president of the company in Brazil, Hugo Nisenbom, said he was surprised by the collegiate’s veto of the merger. He also said that, in addition to withdrawing an alternative treatment for vulnerable and non-hospitalized patients, the decision jeopardizes the continuity of the technical cooperation agreement between the Institute of Technology in Pharmaceuticals (Farmanguinhos) / Fiocruz and MSD.
Formalized in April, the agreement provides for the transfer of technology for the production of molnupiravir to Fiocruz. With this, Farmanguinhos would be responsible for the production and supply of the drug in the SUS. The cooperation also provides for studies on the use of drugs for dengue and chikungunya.
Conitec’s decision was published in the first half of this month. The suggestion was to incorporate the drug for use among patients with mild to moderate, non-hospitalized Covid-19. To substantiate the refusal of incorporation, the commission stated that there was not enough evidence on the outcome and safety of the drug.
The use of molnupiravir was approved on an emergency basis by Anvisa, among patients considered vulnerable. The president of MSD in Brazil stated that the product should be commercialized as of October in the private market. “But we hope that there is also an opportunity for incorporation into the SUS”, he added.
In the interview, granted this Wednesday, Nisenbom also talked about strategies to improve vaccination coverage. He cited as an example the importance of requiring an up-to-date immunization card as a counterpart for income transfer programs. Following are the main excerpts:
How do you assess the reduction in vaccination coverage rates in Brazil?
Take the example of the Hepatitis vaccine. In 2015, coverage was 97%. Last year, the rate was 66%. The polio vaccine, in turn, exhibited a coverage rate of 98% in 2015 and today it is at 49%. In the case of HPV, the data improve, but only because they accumulate. Among girls aged 9 to 14 years, 57% completed the second dose. Among boys aged 11 to 14, 37%.
In a diametrically opposite situation is Covid. People in the country were vaccinated massively. It was a vaccine that did not exist before the pandemic. Although it was new, the threat was there. And in society there was an effort, especially by the media, to show the importance of vaccination. The mismatch worries, because some threats, although they seem a little distant, are approaching. Just look at the measles.
There has been a recent change in HPV vaccination in the National Immunization Program
The age range for vaccine indication was equal between boys and girls. But it’s no use having the vaccine available, increasing the target audience if people don’t get vaccinated. All our lives, we’ve dreamed of a cancer vaccine. And the immunizer protects, not only against cervical cancer, but also against cancer of the mouth, penis and neck. But adherence is still not good. Because? I’ve seen people in wheelchairs because they had polio at a time when there was no vaccine. But awareness is lacking. In the case of HPV: how many doctors actually recommend the vaccine?
In the specific case of the HPV vaccine, do you think that the conservative trend and the false association between the immunizer and the beginning of sexual life can contribute to resistance to the recommendation?
If it exists, it is minor. Because resistance is widespread. She is among all vaccines. What is unquestionable is that we face a communication problem. When there is an effort, a call to indicate the need for vaccination, the population responds. In the case of Covid-19, there was a fantastic job by the media. And the results came, with good vaccination indicators.
But there are other aspects. In the past, there was a public policy in the country that encouraged people to be vaccinated. Not to let the opportunity pass you by. This is essential. There are some studies that make it clear that the longer the interval between the vaccine recommendation and the actual going to the vaccination point, the lower the probability of getting vaccinated. Hence the need to ensure access, quickly. And hence the importance of vaccination in schools. You need to maintain a sense of urgency.
Why was the urgency lost?
In part, because many of the diseases became less common. But the risk exists. If there is an outbreak of hepatitis, anywhere, everyone runs. And it’s not meant to be. There needs to be a coalition, where everyone is committed. Better communication, greater access, greater advice. This is public power, the medical profession, health professionals, the media. Everyone doing their part.
We started a partnership with the National Council of Municipal Health Secretaries to show the importance of vaccination. An awareness campaign. Remind families when it was time for the booster. All this helps. And all professionals need to act. All doctors. Myself. In a consultation, I was advised to have two vaccines, pneumococcal and against herpes zoster.
Are you in favor of keeping the vaccination record up-to-date in income transfer programs?
Totally. For the common good. First, because they save lives, especially at a time when there is misinformation about this wonderful tool that is vaccination. Vaccination is a cost-effective strategy. It is good for the State, there is no better prevention than a vaccine. You avoid disease. You prevent millions of people from getting sick. There are resource savings in addition to risk reduction.
Conitec rejected the incorporation of molnupiravir. If the decision is maintained, how will the agreement with Fiocruz look like?
We were surprised. And respectfully, we will appeal. The decision, as it stands, removes the right to a solution for patients who are more vulnerable, such as the elderly, with cardiovascular complications. The drug is being used in other countries, with good results. In addition, we believe that the price offered was good for the country. We also assess that, if the measure is not reviewed, the basis around the cooperation agreement loses strength. If there is no use in SUS, there is no reason for technology transfer.
Ligia Formenti – Editor and Health Analyst at JOTA