Instituto Bernabeu is in favour of the Covid Vaccines administration, and we believe that it should be recommended to the entire population, as far as it is technically possible and always taking into account the personal situations of each case and advising the utmost prudence.
The aim is to fight against the persistence of the current uncertain situation and its unpredictable ups and downs. Fight against the disease progression and reduce the devastating effects for most professional activities and their unsustainable economic repercussions
- 1 Government guidelines
- 2 Our valuation
- 3 THE SITUATION REGARDING COVID VACCINATIONS AS OF 28th DECEMBER 2020
- 4 Recommendations for COVID vaccine administration
- 5 The case for pregnancy and breastfeeding, as provided for in the Comirnaty (Pfizer/BioNtech) product information sheet
- 6 The case for pregnancy and breastfeeding, as advised by Spanish scientific associations CAV (Vaccine Advisory Committee) and AEP (Spanish Paediatric Association)
- 7 Bibliography
In the upcoming weeks, government guidelines will, in all likelihood, be established regarding important aspects such as:
- Population vaccination order of preference.
- Information update regarding safety in pregnant women and risk groups such as: advanced age, immunosuppression, or coexistence of chronic diseases and special health situations; by antecedents or by individual genetic aspects.
- Security degree in blood, cells and tissues of human origin donations: organ transplants.
- Verified and independent information on the degrees of efficacy and safety to be confirmed, taking into account that currently there are no other alternatives to the well-known recommended prophylaxis measures: distance, mask, frequent hand washing, ventilation.
- Vaccination campaign organizational limits according to the SNS strategies of the and private centres, under government regulations.
- Geographical distribution and health infrastructures operation.
For all of the above, at Instituto Bernabeu we continuously evaluate and assess the situation and, at present, we recommend action guidelines to advise our patients in a clear and realistic way.
Therefore, and after the imminent start of vaccinations against COVID -19, Instituto Bernabeu’s position on the subject is detailed in the following four points:
- Vaccination opinion favourable, after the timely approval of the Health Authorities.
- As indicated in the first vaccines that have already been administered, you must wait two months after the last dose to gestate, both in patients with reproductive issues and any woman seeking pregnancy. Meanwhile, in patients with fertility problems, previous studies, ovarian stimulation, IVF, embryo biopsies and other stages of treatment can be started except embryo transfer.
- Patients who share a proactive vision: vaccinate as soon as possible and follow the previous point steps.
- Patients who are reluctant to vaccination: they can start Assisted Reproduction Treatments, stating this circumstance in the clinical course and always applying the established prevention measures.
We are prepared to always consider your preferences and we maintain our clear determination to offer the safest options in each case.
THE SITUATION REGARDING COVID VACCINATIONS AS OF 28th DECEMBER 2020
The New York Times Coronavirus Vaccine Tracker currently contains a list of 63 vaccines being tested on humans and at least 85 pre-vaccines being tested on animals. Vaccination with the Pfizer vaccine manufactured by a Chinese, German and American consortium has already begun in Spain and many European countries. It is an RNA vaccine. This new technology has already been used to fight other viruses such as rabies and zika virus. The vaccine encodes the SARS-COV-2 spike protein.
The New England Journal of Medicine recently published the results of a randomised, double-blind study of this vaccine. It involved 43,548 participants over 16 years of age. They were administered the vaccine or the placebo in two doses, 21 days apart. Monitoring spanned just two months. The vaccine was shown to give a certain degree of protection 12 days following the first dose and 7 days following the second dose. Its efficacy was 95%.
However, a number of unknowns still remain:
- Possible effects following the two month period after administration of the vaccine.
- Whether or not the vaccine protects against asymptomatic infections in people who have not been given the vaccine. Additionally, the possible outcome if a person is not administered the second dose.
- Efficacy against new strains of the virus.
- Possible effects in other groups of the population: pregnant women, children and people who are immunocompromised.
Recommendations for COVID vaccine administration
In line with the CDC, the American College of Allergy, Asthma and Immunology recommends the following: (*1)
- Patients who have a serious allergic reaction to the first dose should not be given the second one.
- Vaccines must be given in a working hospital environment where urgent healthcare can be provided if a patient has an allergic reaction. People who have been administered the vaccine should be kept under observation for between 15 and 30 minutes.
- Whilst no specific components of the vaccine that cause anaphylaxis have as yet been identified, one of its ingredients is polyethylene glycol which can cause potential negative reactions.
- People who are allergic to foods, latex and common pharmaceutical drugs are not necessarily more likely to have an allergic reaction.
- The vaccine can be given to immunocompromised patients since it does not contain any live viral particles.
The case for pregnancy and breastfeeding, as provided for in the Comirnaty (Pfizer/BioNtech) product information sheet
The initial version of the Comirnaty © product information sheet (the first Covid-19 vaccine administered in Spain) dated 21st December 2020 makes no mention of pregnancy and breastfeeding in the section on contraindications and special precautions. It only mentions the following:
‘There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.’
‘Breast-feeding. It is unknown whether Comirnaty is excreted in human milk.’
Therefore, despite the limited available data (the limiting factor for the product information sheet recommendations), the possibility of vaccination in certain, high-risk cases is left open.
The case for pregnancy and breastfeeding, as advised by Spanish scientific associations CAV (Vaccine Advisory Committee) and AEP (Spanish Paediatric Association)
- In areas where transmission rates are very high, the option of offering the COVID vaccine to pregnant women with a high risk of a serious illness (advanced age, obesity, existing high blood pressure and diabetes or others) and who are at a high risk of exposure to the virus should be assessed. The patient must be provided with all necessary information in order to be able to decide for herself if she will have the vaccine or not.
- To date, in cases of women of a childbearing age who are planning a pregnancy, the criteria has been to wait at least one month between receiving an attenuated vaccine and trying to get pregnant. Erring on the side of caution, this criteria may also be applicable to this vaccine.
- Taking into account the importance of breastfeeding and past experience with other inactive vaccines, the option of allowing women who are given the Comirnaty vaccine to continue breastfeeding should be assessed. The possibility of not postponing vaccination if the mother is a high-risk patient should also be addressed.
(*2) Asociaciones Españolas de Pediatría y de Vacunología y las Sociedades Españolas de Inmunología, Microbiología y de Virología manifiestan su apoyo y asesoramiento a la vacunación contra la covid-19.
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Dr Jordi Suñol and Dr Francisco Sellers. Instituto Bernabeu’s Gynecologists within the Covid-19 follow-up committee.